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MedTech Europe updates MDR symbols guidance

The pan-European industry association MedTech Europe has updated guidance first published in May 2019 relating to the requirements in the Medical Devices Regulation (MDR, 2017/745) for new symbols to indicate specific characteristics of the devices concerned. The guidance was initially issued to provide advice while the applicable international standard, ISO 15223-1, went through the revision…

10 January 2020
MDCG adopts IMDRF guidance on device cybersecurity

The EU Medical Device Coordination Group (MDCG) has issued new guidance to help manufacturers fulfill the cybersecurity requirements in Annex I of the Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostic Regulation (IVDR, 2017/746). The 47-page guidance, which aligns with the cybersecurity guidance published by the International Medical Device Regulators Forum (IMDRF), explains both…

9 January 2020
Brexit: progress being made

Following the General Election the UK Government is moving forward to implement the Withdrawal Agreement and the Northern Ireland Protocol, and negotiate on the future partnership with the EU. In light of the successful vote at Second Reading of the Withdrawal Agreement Bill (WAB), the Prime Minister has now confirmed the Government’s intention to stand…

9 January 2020
Commission issues guidance for Class I manufacturers

The European Commission has published a new guidance document for manufacturers of Class I devices under the medical devices Regulation (MDR, 2017/745), document reference MDCG 2019-15. The 22-page document includes sections on: Definitions Placing on the market Integration of MDR in Quality Management System (QMS) Confirmation of product as a medical device Confirmation of product…

7 January 2020
FDA exempts dozens of devices from 510(k) requirements

The US Food and Drug Administration (FDA) has published a final order that exempts many Class I and Class II medical devices from 510(k) premarket review with effect from 6 January 2020. The final order decreases regulatory burden on medical device manufacturers and eliminates costs associated with complying with those rules, the agency said. Devices…

6 January 2020
Eighth and ninth MDR NBs and one further IVDR NB named

DEKRA Netherlands and Medcert Zertifizierungs-Und Prüfungsgesellschaft Für Die Medizin GmbH, Germany, have been added during December to the list of Notified Bodies (NBs) designated under the Medical Devices Regulation (MDR, 2017/745), making nine in total now available. Around three months ago, the Commission was estimating that 20 NBs would be named before the end of…

2 January 2020
New EU Vigilance Report Forms mandatory from 1 January 2020

Manufacturers should remember that the EU has introduced new forms for vigilance and field safety corrective action (FSCA) reporting, reflecting certain requirements from the Medical Devices Regulation (MDR, 2017/745), which became mandatory from 1 January 2020. The new MIR Form can be downloaded from here, and Help Text, in Excel format, is available from here.

2 January 2020
MDR/IVDR Corrigenda 2 receives EP consent

The second corrigenda to the European Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746) have now been approved by the European Parliament and Council of the EU, confirming clearances in the ENVI and EPSCO committees. This means that now under the MDR, certain devices have been granted additional time for demonstration…

18 December 2019
Boris wins large majority in UK election

So the UK general election has resulted in a larger than expected victory for Boris Johnson and the Conservative Party, meaning that there is no chance that Brexit will not happen, to the chagrin of the vast majority of the medical device industry. UK device manufacturers now hope that a sensible transition agreement can be…

13 December 2019
Partial U-turn on Eudamed delay

As indicated in an earlier news item, while the EU ENVI Committee approved the second corrigenda for the MDR and IVDR, at the EPSCO Council meeting on 9 December, it is reported that the European Commission accepted a concession from the member states to ‘voluntarily’ introduce one Eudamed module by May 2020. The module…

13 December 2019
Commission updates web page on MDR guidance

The European Commission has made changes to its list of guidance documents related to the forthcoming Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/756), which can be found here. Revisions to the list include: Multiple guidances on Unique Device Identification (UDI) MDCG 2019-13 Guidance on sampling of MDR Class IIa /…

12 December 2019
MedTech Europe publishes paper on AI in MedTech

MedTech Europe has published a position paper titled ‘Artificial Intelligence in MedTech: Delivering on the Promise of Better Healthcare in Europe’, in which it welcomes the European Commission’s new focus on Artificial Intelligence (AI) and provides policy recommendations that are especially relevant for the healthcare sector. The medical technology industry “envisages a great potential of…

10 December 2019
COCIR publishes report on radiotherapy equipment age profile and density in Europe

Despite its impressive impact on clinical outcomes, there remains a large gap between how radiotherapy is currently being used in European healthcare settings and its most effective deployment, opines European industry association COCIR in a report titled ‘Radiotherapy Age Profile and Density‘. In addition, COCIR states that these gaps are being exacerbated by shortages of…

9 December 2019
New symbols for MDR now available on ISO website

The Medical Devices Regulation (MDR, 2017/745) requires a significant number of new details to be added to the labels of medical devices. To ease the burden on manufacturers, symbols may be used in order to avoid translation issues. In May 2019, MedTech Europe published guidance on symbols recommended for use on medical device labels for…

6 December 2019
ISO 14971:2019 published

The International Standardisation Organisation (ISO) has now published the latest edition of the medical device risk management standard ISO 14971, titled ‘Medical devices — Application of risk management to medical devices’. The EN version is expected to also be published before the end of 2019. Risk management is a critical cornerstone of compliance with the…

5 December 2019
Second MDR/IVDR Corrigenda published

With less than six months left before the Medical Devices Regulation (MDR, 2017/745) takes effect, the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) has voted to adopt a second MDR corrigendum that will give manufacturers of certain up-classified Class I devices an additional four years to comply. This delay for…

4 December 2019
FDA pushes back timeline for harmonising QSR with ISO 13485

The US Food and Drug Administration (FDA) has revised again the planned timing of release of the Agency’s draft Quality System Regulation (QSR), which is aimed to harmonise FDA requirements for medical device manufacturers with the international quality system standard ISO 13485:2016. FDA’s first target date, announced in May 2018, was April 2019, revised to…

15 November 2019
16th IMDRF meeting in Russia, September 2019 – meeting documents now available

The last meeting of the IMDRF took place in Yekaterinburg in Russia on 16-18 September and the outcome statement of the IMDRF management committee (MC) as well as the presentations delivered during the stakeholders’ meeting are now available on the IMDRF website. Included among the documents are the following final versions related to clinical affairs:…

13 November 2019
BSI Netherlands now designated as NB for MDR

BSI Netherlands is the seventh Notified Body (NB) to be designated under the Medical Devices Regulation (MDR, 2017/745), providing an MDR ‘escape route’ for UK manufacturers who are currently using BSI UK as their NB for the Medical Devices Directive (MDD, 93/42/EEC). If there is a no-deal Brexit on or before 31 January 2020, the…

8 November 2019
One more NB for MDR announced

DARE!! Services has become the first Notified Body from the Netherlands to be designated for the Medical Devices Regulation (MDR, 2017/745). DARE!! is the sixth Notified Dody to be designated under the MDR, the others being are BSI UK, TÜV SÜD, DEKRA Germany, IMQ and TÜV Rheinland. DARE!!’s focus is active non-implantable medical devices.

7 November 2019
It’s official: Eudamed delayed until 2022 for both MDR and IVDR

The European Commission has now concluded the obvious: that the Eudamed database for medical device information required by the Medical Devices Regulation (MDR, 2017/745) and the In Vitro Diagnostics Regulation (IVDR, 2017/746) will not be fully operational by the initial target date of March 2020. The Commission has decided against introducing Eudamed in a modular…

1 November 2019
IVDR now has two Notified Bodies

The NANDO database has been updated to show that there are now two Notified Bodies designated for the In Vitro Diagnostics Regulation (IVDR, 2017/746). The latest designation is for BSI UK, which joins DEKRA Germany with the ability to offer notified body services under the IVDR.

1 November 2019
FDA Modifies List of Recognized Premarket Review Standards

The US Food and Drug Administration (FDA) has updated its list of recognized standards for premarket reviews of medical devices. The revisions include standards in the areas of anesthesiology, cardiovascular, dental, nose and throat, and in vitro diagnostics devices. The list of revisions has been published in the Federal Regiater.

30 October 2019
Donawa Lifescience Consulting announces opening of CRO office in United States

Donawa Lifescience Consulting (DLC), headquartered in Rome, Italy, has announced the opening of a wholly owned company in the US State of Massachusetts, Donawa Lifescience Inc., to promote its Clinical Research Organisation activities to both its existing and potential North American clients. Donawa Lifescience Inc., together with…

25 October 2019
FDA updates 1989 Guidance on Drug Master Files

The 1989 guidance on drug master files (DMFs) is the subject of a revised draft , which deals with submissions of confidential information about facilities, manufacturing, processing, packaging and storing drugs. FDA states that the update includes new procedures for DMFs referenced in abbreviated new drug applications (ANDAs), more detailed instructions on submitting original DMFs…

24 October 2019
FDA publishes its list of guidance priorities for 2020

The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has published a list of the guidance documents that it considers to be of the highest priority for development and publication in 2020. The list, available from here, includes: The A-list; The B-list. Also included, for interest, are copies of the lists of final guidance documents issued in…

15 October 2019
FDA issues two guidance documents on chemically-coated devices

The US Food and Drug Administration (FDA) has published two final guidance documents intended to provide manufacturers with information on potential risks from certain devices, including catheters and guidewires, that are coated in materials to make introduction easier. The guidelines are: ‘Intravascular Catheters, Wires, and…

14 October 2019
ISO 13485 Confirmed until 2024

Good news for medical device manufacturers has emerged from the ISO/TC 210 meeting that took place in London during week commencing 7 October 2019, in that the Technical Committee took action to confirm ISO 13485:2016 for an additional standard period (five years), until 2024. The ballot was nearly unanimous with just one vote for revision and…

14 October 2019
MDCG publishes guidance on classifying software under the MDR and IVDR

The European Commission’s Medical Device Coordination Group (MDCG) has released guidance to help medical software manufacturers understand the criteria for the classification of software under the Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746). The document is titled ‘Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and…

14 October 2019
DEKRA Germany first IVDR Notified Body to be designated

German Notified Body DEKRA, already designated under the Medical Devices Regulation (MDR, 2017/745) has become the first Notified Body to be designated under the In Vitro Diagnostics Regulation (IVDR, 2017/746). A copy of the designation notice can be found here.

11 October 2019
MDCG publishes guidance on MDR Article 120 transitional provisions

The Medical Device Coordination Group (MDCG) of the European Commission has released a guidance document covering the ransitional provisions in Artilce 120 of the Medical Devices regulation (MDR, 2017/745) to clarify how manufacturers may take advantage of Notified Body certificates issued under the Medical Devices Directive (MDD, 93/42/EEC) and Active Implantable Medical Devices Directive (AIMDD, 90/385/EEC)  while…

8 October 2019
IMDRF publishes draft guidance on cybersecurity

The International Medical Device Regulators Forum (IMDRF) has released its draft guidance document dealing with the cybersecurity of medical devices. The draft, titled ‘Principles and Practices for Medical Device Cybersecurity’, with the intent of facilitating better international regulatory convergence on the topic. The 45-page guidance document, developed by a working group led by officials from the US…

7 October 2019
FDA introduces patient engagement initiative for clinical studies

The US Food and Drug Administration (FDA) has released draft guidance on ‘Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations’. The draft provides the Agency’s proposed recommendations for manufacturers to engage patients in multiple aspects of medical device clinical investigation design. The draft was introduced by a press statement from the FDA Acting Commissioner. The Agency…

2 October 2019
FDA releases draft guidance on future eSubmission requirements

The US Food and Drug Administration (FDA) has published a new draft guidance with “both binding and nonbinding provisions” related to electronic submissions for medical devices. At the outset of the seven-page draft, FDA warns that it has concluded “that it is not feasible to describe and implement the electronic format(s) that would apply” to all the device submissions…

27 September 2019
TÜV Rheinland Becomes 5th MDR Notified Body

The European Commission has announced that Germany’s TÜV Rheinland is the fifth notified body (NB) to be designated under the Medical Devices Regulation (MDR, 2017/745). The latest version of the NANDO database for the MDR can be accessed here. A TÜV Rheinland spokesperson advised that “We are accepting applications under MDR. We have also applied under IVDR…

27 September 2019
EC medical device unit set for move

Responsibility for medical device regulations is set to move from DG GROW to DG SANTE. The announcement was made by European Commission President-elect Ursula von der Leyen as she named her new team of Commissioners who will take over their portfolios in 2020. Stella Kyriakides, a Cypriot medical psychologist, is to lead on health. In her…

26 September 2019
Commission updates guidance on the SSCP

The Medical Devices Regulation (MDR, 2017/745) requires that manufacturers draw up a summary of safety and clinical performance (SSCP) for implantable devices and for class III devices, other than custom-made or investigational devices. The SSCP must be validated by a notified body (NB) and made available to the public via the European database on medical…

25 September 2019
Final SCHEER guidelines on phthalate benefit risk now available

The European Commission has now released final guidelines from SCHEER on how to perform a benefit-risk analysis for phthalates in medical devices, following a public meeting to discuss the draft guideline in April. As a result of the public availability of the draft, 197 submissions from 19 contributors (providing 378 comments and additional references) provided input to different chapters and…

19 September 2019
FDA updates RTA Guidance

The US Food and Drug Administration (FDA) has updated its final guidance on its “refuse-to-accept” (RTA) policy for 510(k) submissions. The revised guidance continues to include detailed checklists for Traditional, Abbreviated and Special 510(k)s, in which some detail changes have been made. The agency will respond to submissions within 15 calendar days from receipt with…

17 September 2019
FDA publishes new 510(k) Guidances

The US Food and Drug Administration (FDA) has updated three guidance documents on preparation and formatting of Traditional, Abbreviated and Special premarket notifications (510(k)s). The documents are: Format for Traditional and Abbreviated 510(k)s The Abbreviated 510(k) Program The Special 510(k) Program The guidance for Traditional and Abbreviated 510(k) formatting does not appear to change the 2005 guidance significantly…

16 September 2019
AAMI TIR102:2019 mapping QSR to ISO 13485:2016, published

The Association for the Advancement of Medical Instrumentation (AAMI) has now published AAMI TIR102:2019, which maps the US Food and Drug Administration (FDA) Quality System Regulation (QSR, 21 CFR 820) to ISO 13485:2016 and vice versa. The abstract for the Technical Information Report (TIR) reads: “This document provides a mapping of the US FDA 21 CFR…

11 September 2019
FDA issues final guidance and checklists for de novo submissions

A final version of the draft document issued in October 2017 relating to US Food and Drug Administration (FDA) acceptance of de novo submissions has now been issued by the Agency. Titled ‘Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff’, 9 September 2019, it explains the procedures…

11 September 2019
MDR Corrigendum 2 to expand grace period to Class IR devices?

The European rumour mill is busy at work talking up the prospect of a second corrigendum to the Medical Devices Regulation (MDR, 2017/745) being issued within the next few weeks, and that it will include an extension of the MDR Article 120 provisions to Class I devices that need to be reprocessed between uses (so-called…

11 September 2019
Danish Competent Authority offers free MDR advice pilot study to device manufacturers

As part of a new pilot project, the Danish Medicines Agency is offering regulatory advice especially for startups and small and medium sized medical device manufacturers as well as educational and research units. As the agency explains: “We are offering one-to-one meetings to help them get off on the right foot. We offer these meetings…

10 September 2019
FDA issues final guidance on Humanitarian Device Exemption process

The US Food and Drug Administration (FDA) has finalised guidance on the Humanitarian Device Exemption (HDE) process, updating the draft issued in June 2018, and superseding ‘Guidance for HDE holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff, Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers’. dated 8 July 2010. The new guidance,…

9 September 2019
MHRA updates Brexit ‘no deal’ guidance

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published an update to its guidance for medicines and medical devices in the event of a no deal Brexit taking place. The latest guidance can be obtained from here.

5 September 2019
IMDRF Seeks Feedback on two consultation documents

The International Medical Device Regulators Forum (IMDRF) has issued two new draft documents for consultation and comment, these being: Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews, and IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes. Comments are due by 10 September 2019 and…

26 August 2019
Another Notified Body shuts up shop

This time it is German Notified Body (NB) ECM (ecm Zertifizierungsgesellschaft für Medizinprodukte in Europa GmbH) which has decided to withdraw from offering NB services under the current directives, in addition to not applying for designation under the new regulations. ECM had been under notice from the Commission for some time concerning corrective actions that…

23 August 2019
EU Common Specification draft for reprocessing single-use devices

According to the latest update to the European Commission’s ‘rollling plan’, the draft implementing act relating to the requirements for organisations that intend to reprocess devices that are labelled by their manufacturers as being suitable for single-use only is now available for public comment until 20 August 2019. The draft implementing act, titled ‘Single-use medical devices…

16 August 2019
Two more Notified Bodies designated under the MDR

News from the European Commission and NANDO website is that an additional two Notified Bodies (NBs) have now been designated under the Medical Devices Regulation (MDR, 2017/745), but only one of these has yet appeared on the NANDO website. DEKRA Germany has become the third NB designated under the MDR, with an entry on the NANDO…

16 August 2019
FDA publishes draft Guidance on Testing and Labeling Devices in the MR Environment

The US Food and Drug Administration (FDA) has issued a draft guidance document titled ‘Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Draft Guidance for Industry and Food and Drug Administration Staff’. “This draft guidance document is anticipated to aid in consistency of reviews, testing, and MRI safety labeling across a…

9 August 2019
FDA publishes fees for fiscal year 2020

The US Food and Drug Administration has released details of the fees that will apply to medical device manufacturers seeking market clearance of new products for the US market for the Agency’s fiscal year 2020, which starts on 1 October 2019. A general 6% increase has been introduced, but a reduced increase is noted for…

4 August 2019
MHRA revises clinical investigation guidance

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated 2013 clinical investigation guidance to better reflect the forthcoming Medical Device Regulation (MDR, 2017/745). The guidance introduces the need for ensuring that the “anticipated benefits to the patients enrolled in the clinical trial justify the foreseeable risks” in accordance with Article 62 of MDR,…

1 August 2019
Commission publishes draft regulation on single-use device reprocessing

The European Commission has published a draft regulation setting out rules for the application of the Medical Device Regulation (MDR, 2017/745) with regard to common specifications for the reprocessing of single-use medical devices. Whether or not such reprocessing is permitted is in the gift of the member states. Some, such as France, have outright banned the practice…

30 July 2019
MHRA offers to support ‘orphaned’ manufacturers

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has put in place a process to support UK manufacturers affected by LRQA’s decision to close its medical device business. Subject to some conditions, MHRA is able to support LRQA manufacturers in their transition to a new notified body by allowing products to continue to be…

26 July 2019
ECHA recommends ending medical device exemption for DEHP

The European Chemicals Agency (ECHA) has recommended removal of the medical device exemption from REACH Authorisation for four phthalates, including DEHP. The dossier is now with the European Commission, which will take the final decision together with the EU Parliament and the Council. The four substances BBP, DBP, DIBP and DEHP were identified as substances…

25 July 2019
MDR implementation: USA, Canada and South Korea voice concerns at WTO

The latest to take aim at the EU regarding the pace of MDR implementation were delegations from the USA, Canada and South Korea at the WTO Goods Council meeting on 8/9 July 2019. According to notes of the meeting: “The EU risks disrupting its US$ 125-billion medical device market and harming patients’ access to medical technologies…

24 July 2019
Commission ‘pre-notifies’ call for experts

The European Commission has published advance notice of its intention later in the year to seek clinical and other experts to participate in the MDR and IVDR Expert Panels. The panels are intended to support the assessment of specific high-risk devices and to contribute to the prospective improvement of the overall framework by advising the Commission, the…

22 July 2019
IMDRF consults on adverse event reporting

The international Medical Device Regulators Forum (IMDRF) has published a consultation document on terminologies for categorized adverse event reporting. The consultation which runs until 10 September 2019 covers terminology, codes and coding structure. A number of annexes deal with cause investigation, health effects and terms and codes for parts and components. However, as yet there is not…

19 July 2019
Commission updates MDR Notified Body status

The European Commission has made available on its website a short PowerPoint presentation advising on the latest state of play with regard to the assessment of Notified Bodies under the Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746). The presentation, available from here, advises that 51 applications have now been received, 41…

16 July 2019
European Commission publishes two guidance documents for MDR

The European Commission has just released two MDR guidance documents covering the subjects of Article 15, on the ‘Person Responsible for Regulatory Compliance’ (PRRC), and Article 18 on ‘Implant Cards’. The documents are available from the following links: MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation…

2 July 2019
Canada Proposes New Device Regs to Improve Safety

On June 15, 2019, Health Canada pre-published proposed regulations in Canada Gazette, Part I, to amend the Medical Devices Regulations to: Operationalize the powers included in Vanessa’s Law to require assessments, tests and studies by establishing the rules needed to structure the exercise of those powers for medical devices; Create new rules for reporting actions in…

1 July 2019
FDA publishes final guidance for ultrasound devices

The US Food and Drug Administration (FDA) has issued final guidance for manufacturers seeking 510(k) clearance for diagnostic ultrasound systems and probes. The guidance, which replaces draft guidance published in October 2017, recommends regulatory approaches for diagnostic ultrasound systems. FDA explains that: “This final guidance provides recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers….

30 June 2019
Commission admits to potential device shortages because of MDR

A new Commission ‘Factsheet for healthcare professionals and health institutions’ acknowledges there may be supply chain problems during the MDR transition, stating the potential for some devices to “become temporarily unavailable.” The full extract from the Factsheet reads: “These changes could have consequences for the availability of medical devices for health institutions. For instance, manufacturers may choose to…

29 June 2019
Commission publishes the draft standardisation request for MDR and IVDR

The European Commission has released a copy of the draft harmonised standards request to CEN and CENELEC, titled “Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746”, copy available from here. The previous draft from the Commission received criticism…

28 June 2019
ISO 20916:2019 published

ISO 20916:2019, ‘In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice’, defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes….

24 June 2019
Swiss NB numbers continue to fall

Because of political disagreements between Switzerland and the EU with regard to bilateral access agreements, including that covering medical device regulation, there is uncertainty over the future of the Institutional Agreement (InstA) with the EU, and this has been making difficulties for Swiss device manufacturers and for the country’s two remaining notified bodies (down from…

21 June 2019
One year out, COCIR makes MDR recommendations

With a year to go before the MDR date of application, COCIR has published a series of recommendations. This is an update from the ‘halftime’ assessment published in November last year and the conclusions are not encouraging. COCIR sees very little progress in the last six months. Despite the considerable resources that industry has invested in…

19 June 2019
Commission designates UDI organisations

The European Commission has designated four organisations for issuing Unique Device Identifiers (UDI). On 6th June it published ‘Implementing Decision 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices’. The organistations are: GS1 AISBL Health Industry Business Comunications…

18 June 2019
Commission publishes notified bodies Q&A

The Medical Device Coordination Group has published a Q&A document on requirements for notified bodies. The issues covered have been identified in the context of joint assessments, and the document may be updated from time to time as new issues are identified. The Q&As cover technical aspects relating to notified bodies’ operations, such as “Are CABs obliged to…

18 June 2019
LRQA withdraws NB services for MDD/IVDD

UK Notified Body (NB) LRQA has announced its withdrawal of services relating to the MDD and IVDD, with 90 days’ notice being provided to its client base. LRQA has also confirmed that it will not be seeking to become a NB for the new MDR and IVDR. All LRQA clients have been informed directly, and LRQA is working…

17 June 2019
MedTech Europe publishes symbols guidance

MedTech Europe (MTE) has issued a guidance document on the use of symbols to indicate compliance with the MDR. The aim is to help manufacturers comply with new MDR requirements in an efficient manner before the relevant international standard is available. The graphical symbols in the guidance have all been validated with users, including patients and healthcare…

6 June 2019
EMA publishes draft combination products guideline

The European Medicines Agency (EMA) has published a draft ‘Guideline on the quality requirements for drug-device combinations’. The new document provides guidance on the documentation expected for Drug-Device Combinations (DDCs) in the quality part of the dossier for a marketing authorisation application or a variation application. Products covered include medicinal products which contain one or more…

5 June 2019
Another Notified Body shuts up shop

UL International, designated as a Notified Body (NB) by the UK Medicines and Healthcare products Agency (MHRA) is one more NB that has decided not to offer services under the Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746), and has reached an agreement with the Polish NB Polskie Centrum Badan I…

3 June 2019
EU designates TÜV SÜD as second Notified Body under MDR

German Notified Body (NB) TÜV SÜD is the second NB to be designated under the EU Medical Devices Regulation (MDR, 2017/745). The Commission’s Nando database on NBs was updated to reflect this latest development on 22 May 2019. TÜV SÜD says it has a large capacity, with delegates at the MedTech Forum in Paris earlier…

29 May 2019
European device Borderline Manual updated

The European Commission has updated its ‘Manual on borderline and classification in the community regulatory framework for medical devices’, available from here. New entries include: Automated external defibrillator storage units Lubricants intended for alleviation of vaginal dryness Medication decision support software

24 May 2019
FDA releases final version of Q-Sub guidance

The US Food and Drug Administration (FDA) has published the final version of its guidance document titled ‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’, superseding the draft published in June 2018.
As in the draft, the guidance provides advice to medical device manufacturers on the following types of …

7 May 2019
FDA publishes list of patient priority areas

The US Food and Drug Administration (FDA) has published a list of patient preference priority areas that may be useful in developing medical devices and in the agency’s assessment of those devices.
“Patients are the experts in living with their disease or condition, the outcomes that are most important to them, and how they weigh benefits and risks…

5 May 2019
FDA announces implementation of CDRH’s new Office of Product Evaluation and Quality

The US Food and Drug Administration (FDA) has officially opened the new Office of Product Evaluation and Quality (OPEQ) at the FDA’s Center for Devices and Radiological Health (CDRH). OPEQ implementation is a key step in the Center’s reorganization that is planned …

3 May 2019
FDA finalises guidance on non-clinical bench performance testing

The US Food and Drug Administration (FDA) has published a final guidance document titled ‘Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions’, copy available from here. The guidance supersedes the draft issued in May 2018, and includes formatting and content recommendations for test report summaries, test protocols, and complete test…

30 April 2019
FDA releases draft guidance on becoming ‘recall ready’ in the event of a voluntary recall

The US Food and Drug Administration (FDA) has issued a draft guidance document titled ‘Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C’, which states that it is critical for manufacturers of FDA-regulated products to be ‘recall ready’ should there be a need to instigate a voluntary recall. The draft, copy available from…

30 April 2019
MDCG publishes guidance on legacy device registration

The European Commission’s Medical Device Co-ordination Group (MDCG) (MDCG) has published two papers on registration of legacy devices on the Eudamed database: Timelines for registration of device data elements in Eudamed Registration of legacy devices in Eudamed The first of these highlights an inconsistency in the MDR text, stating that “On the one hand, Article 123(3)(d)…

30 April 2019
FDA Finalizes Guidance on UHMWPE in Orthopedic Devices

The US Food and Drug Administration (FDA) has published final guidance on the use of various types of ultrahigh molecular weight polyethylene (UHMWPE) in orthopedic devices. The 18-page guidance finalizes a draft version released for comment in 2016 and provides recommendations for characterizing and testing Class II and III orthopedic devices that contain UHMWPE materials…

29 April 2019
FDA issues draft guidance on labeling for surgical staplers and staples

The US Food and Drug Administration (FDA) has published draft guidance on labeling of surgical staplers and staples for internal use, following multiple reports of patient deaths and injuries resulting from malfunction and misuse. The draft recommends that manufacturers place visible contraindications on their products regarding their use on tissues for which stapling is overly…

29 April 2019
IMDRF consults on clinical evaluation documents

The International Medical Device Regulators Forum (IMDRF) has issued a number of documents on clinical evaluation for consultation: Clinical Evaluation Clinical Evidence – Key Definitions Concepts Clinical Investigation The first of these provides general information on clinical evaluations such as what they are, when they are undertaken, why they are important, the process for carrying…

24 April 2019
MHRA updates guidance for virtual manufacturers

MHRA has now published the final version of its lomg-awaited guidance document ‘Virtual manufacturing of medical devices’. New sections now cover the options for a virtual manufacturer when their OEM loses their CE certificate, and on changing from being the legal manufacturer to being the distributor. In the first case, the manufacturer should: a) obtain…

24 April 2019
FDA issues draft guidance on assessment of medical devices containing nitinol

FDA explains in the draft guidance, titled ‘Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol’, that nitinol is a commonly used material in the medical device industry, with device manufacturers using nitinol’s unique properties (i.e., pseudoelasticity and shape memory behavior) to design innovative medical devices that would not be possible with conventional materials….

22 April 2019
FDA releases draft guidance on quantitative imaging devices

The US Food and Drug Administration (FDA) has issued a draft guidance document on premarket submissions for devices with quantitative imaging functions, titled ‘Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions’, copy available from here. FDA explains that most medical images require a trained physician to identify the presence or absence of a certain…

22 April 2019
MedTech Europe publishes materials declaration guidance

Companies are faced with ever-increasing requirements to document and report chemical composition, to track the volumes of substances, and to document the origin of product components, etc. To assist in this, MedTech Europe (MTE) has published a new paper, ‘Guidance on Material Declaration in the In Vitro Diagnostic Medical Device and Medical Device Industry’. The…

15 April 2019
COCIR publishes harmonised standards position paper

COCIR, the European Co-ordination Committee of the Radiological, Electromedical and Healthcare IT Industry, has issued a position paper suggesting ways for the Commission to get the system for mandating and approving harmonised standards back on track. The paper makes a number of recommendations: Speed up the approval of the Standardisation Request; Ensure flexibility in the…

10 April 2019
GMDN now available as free service

The GMDN Agency has announced that GMDN, a global standard for identifying millions of medical devices around the world, has now been made freely available to all users since 1 April 2019. The new free Basic Membership will allow users access to the GMDN data, while the existing membership charges will remain for manufacturers needing…

5 April 2019
Italian CND nomenclature system selected for EUDAMED II

The European Medical Devices Coordination Group (MDCG) has apparently agreed, at its 14-15 February 2019 meeting, to endorse the Italian ‘Classificazione Nazionale Dispositivi Medici’ (CND) nomenclature system for use with the EUDAMED II medical device centralised database, to support operation of the Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746). That…

27 March 2019
Commission releases MDR/IVDR corrigenda

The eagerly-awaited corrigenda for the European Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746) have now been released by the European Commission. To many in the industry, the revisions to the regulations will be disappointing, as they correct only typographic or other obvious errors in the original documents, without addressing any…

22 March 2019
Preliminary SCHEER guidelines on phthalate benefit risk now available

As reported in this news column on 1 March 2019, the European Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has now published its preliminary report on the benefit risk assessment (BRA) of phthalates in medical devices, following the committee’s September 2017 acceptance of a request from the European Commission’s Directorate-General for Internal Market,…

21 March 2019
Commission opens new web portal for medical devices

The European Commission has launched a new web portal to try and improve access to stakeholder for items related to the new medical devices regulations (MDR, 2017/745 and IVDR, 2017/746). Highlights Regulatory framework Current Directives on medical devices New Regulations on medical devices Together with the opportunity to sign up for a subscription to a…

18 March 2019
FDA finalises guidance on devices with animal-derived material

The US Food and Drug Administration (FDA) on has finalised its guidance, drafted in 2014, for medical devices containing animal-derived materials. The Agency states that the final guidance seeks to help industry address the risks of human pathogens that could contaminate animal material, and thus be present in a medical device that contains contaminated material…

16 March 2019
CDRH Reorganizes

The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) is beginning to implement a reorganization that will, according the the Agnecy, “create an agile infrastructure that can adapt to future organizational, regulatory and scientific needs”.  Since June 2018, CDRH has been piloting a more integrated approach to device safety throughout…

14 March 2019
FDA downclassifies software for contraception

The US Food and Drug Administration (FDA) has reclassified software applications for contraception as Class II medical devices with special controls, making them exempt from premarket notification requirements. The Agency has moved this type of medical device type automatic Class III into Class II (special controls) because it has determined that the change “will provide…

11 March 2019
COCIR & MedTech Europe send open letters to the Commission on Brexit

COCIR, the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry, has expressed its concern about the lack of a transition period with the UK in the event of a no-deal Brexit in an open letter to the Commission and Competent Authorities, dated 7 March 2019. In introducing the subject in the letter,…

9 March 2019
Who can be the UK responsible person post-Brexit?

The MHRA has published the draft Statutory Instrument that, when finalised, will replace the current UK Medical Device Regulations, and despite the publication of multiple new or updated MHRA guidance documents on 26 February 2019, confusion remains over the definitions and roles of the UK responsible person and the importer, should the manufacturer be located outside of…

9 March 2019
FDA proposing to upclassify surgical staplers for internal use to Class II

The US Food and Drug Administration (FDA) has written to healthcare providers because the Agency is concerned by the increasing number of adverse events associated with surgical staplers and staples for internal use. As a result, FDA is providing additional recommendations for healthcare providers to help protect patient safety and reduce the risk of adverse…

8 March 2019
Which nomenclature system will be selected for MDR/IVDR?

There was a time that many people in the healthcare workspace considered that the only option for a nomenclature system to be used for EUDAMED II, which underpins the new Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746), would be the Global Medical Device Nomenclature (GMDN), but rumours are that this…

8 March 2019
New version of the European Commission’s IVDR/MDR rolling plan published

MedTech Europe reports that the Commission’s ‘Implementation Rolling Plan’ was updated on 19 February 2019, providing revised timing and next steps for the development of implementing regulations and other actions/initiatives, as follows: MDR Annex XVI products without an intended medical purpose: Q1 2019’ is the new date for the Commission’s informal consultation on the draft text…

1 March 2019
SCHEER draft guidelines on phthalates in medical devices to be published shortly

The European Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) is due to publish its preliminary report on phthalates in medical devices on this webpage on 18 March 2019, following the committee’s September 2017 acceptance of the benefit-risk assessment request from the European Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. In addition, the Commission…

1 March 2019
FDA updates acceptance policies for 510(k)s and PMAs

The US Food and Drug Administration (FDA) has published two updated guidance documents on how it accepts, reviews and may refuse to accept 510(k) and pre-market approval (PMA) submissions. The two guidelines include only minor revisions, acording to the Agency, they were apparently reissued to reflect new requirements for clinical studies and certain other updates….

26 February 2019
Commission publishes critical new Q&A on no-deal Brexit

The European Commission has issued a new guidance on what happens in the event of a ‘no-deal Brexit, in a Q&A format, titled ‘Questions and Answers related to the United Kingdom’s Withdrawal from the European Union with regard to Industrial Products’. The document relates not just to medical devices, but to all ‘industrial products’, and…

25 February 2019
MedTech Europe publishes materials declaration guidance

Since the entry into force of new regulations such as REACH, MDR, the California Proposition 65 List and the inclusion of IVDs and medical devices into the scope of the RoHS Directive, the demand for information on material compositions for the purpose of compliance has increased rapidly. The regulatory requirements and related requests are increasingly…

22 February 2019
MDCG issues new guidance on UDI for combination products

The European Commission Medical Devices Coordination Group (MDCG) has published a new guidance document titled ‘MDCG 2019-2: Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017’. The Scope of the guidance explains that: “Article 1(8),1(9), 1(10) of the Medical Devices Regulation (EU) 2017/745…

20 February 2019
MDCG publishes meeting schedule for 2019

The European Commission Medical Devices Coordination Group (MDCG) has set out its plans for meetings of the MDCG and its subgroups for 2019, which includes full MDCG meetings on: 14-15 February 9-10 April 14 June A copy of the meeting schedule can be obtained from here.

20 February 2019
FDA issues draft guidance on ‘Feedback After Certain FDA Inspections’

The US Food and Drug Administration (FDA) has issued a draft guidance titled ‘Nonbinding Feedback After Certain FDA Inspections of Device Establishments’, which proposes a method for medical device manufacturers to request nonbinding feedback from FDA in response to certain kinds of observations the FDA may document during an inspection of the device establishment that are…

16 February 2019
‘No-deal’ Brexit threatens major disruption for medical device manufacturers

UK-based Notified Bodies and Authorised Representatives provide a significant proportion of the services mandated before medical device manufacturers can place their products on the European market. Notified Bodies are needed for all but non-sterile, non-measuring, Class I devices; Authorised Representatives are required by all non-European manufacturers exporting devices to Europe. Of the four UK-based Notified…

13 February 2019
Commission issues MDR/IVDR Factsheets

The European Commission has published a series of factsheets and infographics as part of their  ‘Communications Campaign’ on the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR). Further documents are expected such as translations of the documents into additional languages and other factsheets aimed at healthcare professionals…

9 February 2019
FDA exempts certain Unclassified Devices from Premarket Notification

The US Food and Drug Administration (FDA) issued a revised guidance to advise that it intends to exempt certain unclassified devices from premarket notification requirements, updating and superseding an earlier guidance from August 2015. The guidance indicates that six device categories should be exempted, these being: ear, nose and throat; gastroenterology-urology; general and plastic surgical; neurological; obstetrical and gynecological; and…

9 February 2019
Combination Product Premarket Pathway principles explained in new FDA draft guidance

The US Food and Drug Administration has published a draft guidance document titled ‘Principles of Premarket Pathways for Combination Products: Guidance for Industry and FDA Staff’. The guidance presents the current thinking of FDA on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate. The guidance…

7 February 2019
‘No deal’ MHRA device registration scheme announced

The UK MHRA has published its plans for a comprehensive medical device registration scheme to be implemented in the event of a ‘no deal’ Brexit. Published as part of its updated Brexit guidance, the registration scheme will require all medical devices, active implantable medical devices, in vitro diagnostic medical devices (IVDs) and custom-made devices will…

5 February 2019
Brexit contingency plans published

In addition to the UK introducing a ‘Brexit Portal’ on the government website, the European Commission and the Irish Government have published their contingency plans in the event of a ‘no deal’ Brexit. Content will continue to be added in the coming months, with a call from Government for Members to submit feedback on its usefulness….

4 February 2019
Medical device issues raised at EU-US trade talks

Following the trade policy meeting in July 2018 between Presidents Trump and Juncker, which included medical devices as one of several areas where future cooperation might lead to reduced regulatory costs, the US and the EU have now pledged to cooperate to ensure that the US and EU electronic database specifications for device unique device identifiers…

4 February 2019
BSI publishes PMS guidance

BSI has published a new document its Compliance Navigator series. The latest edition covers the important area of Post Market Surveillance where the manufacturer’s responsibilities have considerably increased under MDR compared to what was expected under the MDD. This is consistent with the gathering of information from the post-production phase referred to in EN ISO…

1 February 2019
IMDRF considers global sungle device review programme

The International Medical Device Regulators Forum (IMDRF) is apparently making progress in developing a medical device single review program (MDSRP) (only nearly 30 years after the idea was first raised by Gordon Higson, in Nice, 1992, that led to formation of the Global Harmonisation Task Force (GHTF), the forerunner of IMDRF). Members of the IMDRF’s Good…

31 January 2019
MHRA issues updated No Deal Brexit guidance as deadline approaches

Following the consultation on how medicines, medical devices and clinical trials would be regulated in a no-deal scenario, MHRA has published updated guidance setting out the UK’s proposed arrangements for regulation in the event of the country leaving the EU on 29 March 2019 with no deal. For medical devices, the key arrangements include: for…

31 January 2019
EMA lowers flag at London HQ

Staff at the European Medicines Agency have lowered the flags outside their London offices as they prepare to move to Amsterdam. The flag lowering took place as the EMA “symbolically said goodbye” to the city it has called home since its creation in 1995. The EMA is set to leave its offices in London March…

30 January 2019
FDA opens public comment period for Medical Device Safety Action Plan

The US Food and Drug Administration (FDA) has released details on how the agency plans to re-vamp the 510(k) pathway, by which a majority of medical devices make it to market. FDA has announced that it was opening a public comment period on its Medical Device Safety Action Plan. The document outlines the agency’s goals…

29 January 2019
EU MDR has its first Notified Body designated

BSI, the UK Notified Body for medical devices under the Medical Devices Directive (MDD, 93/42/EEC) has just announced that it has become the first Notified Body to be designated under the new Medical Devices Regulation (MDR, 2017/745), retaining its Notified Body reference number, 0086, and advising that it has been designated for the full scope applied…

24 January 2019
IEC publishes Technical Report PD IEC/TR 60601-4-3:2018

IEC has published Technical Report PD IEC/TR 60601-4-3:2018, ‘Medical electrical equipment. Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements.’ Prior to formally working on producing the fourth edition of the ubiquitous IEC 60601-1 standard for medical electrical equipment, IEC has taken the step…

23 January 2019
Notified Bodies voice concerns on MDR progress

TEAM NB, the European Association of Medical Device Notified Bodies and NB-MED, the European coordination group for notified bodies, have published a white paper reviewing progress over the year since notified bodies were first allowed to apply for designation under the the Medical Device Regulations. In July 2017, thirty seven notified bodies responded to a…

23 January 2019
FDA Releases Five-Year Plan for Sentinel System

The US Food and Drug Administration (FDA) has unveiled a five-year strategy for its Sentinel post-market safety surveillance system, detailing major goals through the year 2023. The agency wants to create a more robust system that can make better use of the data Sentinel gathered over the past decade. It also plans to invest more heavily…

22 January 2019
TEAM-NB updates NB application progress against IVD Regulation

Following interest from the devices sector concerning the designation of notified bodies in the framework of the IVD Regulation (2017/746), and as an act of transparency, TEAM-NB has published data in a press release concerning the applications by 35 notified bodies, both TEAM-NB members and non-members. Data collection was completed on 11 January 2019 following a survey in CIRCABC. The…

21 January 2019
Revised ISO 14971 standard nearing publication

The International Organization for Standardization (ISO) has strengthened benefit-risk language in the latest edition of ISO 14971, the voluntary standard that instructs device-makers on how to best conduct risk management. Regulators – including the US FDA – are increasingly considering benefit-risk when weighing product availability and regulatory compliance. The Final Draft International Standard (FDIS) is currently undergoing…

16 January 2019
FDA issues guidance on medical device accessories

The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has published a list of guidance documents it plans to publish in FY 2019, as well as a list of finalized guidances available for public comment. The center intends to publish final guidance in 2019 on the breakthrough devices program, on…

8 January 2019
‘Safety and Performance’ 510(k) to augment Abbreviated 510(k)

There are three types of Premarket Notification 510(k)s that may be submitted to the US Food and Drug Administration (FDA): Traditional; Special; and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the “New 510(k) Paradigm” to help streamline the 510(k) review process. FDA has now issued final guidance on a modified Abbreviated pathway, to be…

4 January 2019
ECHA launches consultation on REACH Authorisation for DEHP and other phthalates

On 12  December 2018, the European Chemicals Agency (ECHA) launched the second public consultation on a draft recommendation to amend Annex XIV (Authorisation List) with regard to DEHP. The four phthalates: bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP) were identified as substances of very high concern (SVHCs) due…

3 January 2019
Commission announces new vigilance templates

A new Field Safety Notice (FSN) form), customer and distributor/importer reply forms, and Q&A have been posted to the European Commission’s website here including: Field Safety Notice Template FSN Customer reply FSN Distributor/Importer reply FSN Q&A In addition to the existing Trend Report Periodic Summary Report Although the FSN form is not mandatory to use…

24 December 2018
2019 FDA User Fees announced

The US Food and Drug Administration (FDA) has announced small increases in user fees for fiscal year 2019, with the new fees, coming into effect on 1 October 2018, being: * Note: all types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to…

22 August 2018
Commission issues ‘Fact Sheets’ on MDR and IVDR Transitions

The European Commission (EC) has issued two ‘Fact Sheets’ to assist manufacturers in the transition from the Medical Devices and Activive Implantable Medical Devices Directives (MDD and AIMDD) to the Medical Devices Regulation, and also from the In Vitro Diagnostics Directive (IVDD) to the In Vitro Diagnostics Regulation (IVDR). The Fact Sheet for the MDR…

25 July 2018
FDA announces large hike in device user fees for FY 2018

Following President Trump’s signing into law of the bill that reauthorizes the US Food and Drug Administration (FDA) user fee programs for drugs, biosimilars and medical devices through 2022, the agency has now published the fees for device-related interactions with FDA. The new fees, which become effective from 1 October 2017, reverse the trend from…

29 August 2017
19 cities vie for EMA after Brexit

The European Commission has received 19 offers from European cities to host the European Medicines Agency’s (EMA) headquarters as it moves from London’s Canary Wharf following Britain’s decision to leave the EU. A final decision on the new location will be taken at the General Affairs Council and announced on 20 November 2017. The cities…

4 August 2017
EMA publishes its plan for post-Brexit

The US Food and Drug Administration (FDA) has introduced a new pilot program, called the ‘Software Precertification (PreCert) Pilot Program’, explaining that FDA’s traditional approach to moderate and higher-risk, hardware-based medical devices is not well suited for the faster and iterative design, development, and validation used for software products. The European Medicines Agency (EMA) has developed…

4 August 2017
FDA introduces ‘Digital Health Software Precertification (PreCert) Program’

The US Food and Drug Administration (FDA) has introduced a new pilot program, called the ‘Software Precertification (PreCert) Pilot Program’, explaining that FDA’s traditional approach to moderate and higher-risk, hardware-based medical devices is not well suited for the faster and iterative design, development, and validation used for software products. The Software PreCert Pilot Program is a…

3 August 2017
FDA issues draft guidance on filing a ‘Pre-Request for Designation’

The US Food and Drug Administration has published a draft guidance document titled ‘How to Prepare a Pre-Request for Designation (Pre-RFD): Draft Guidance for Industry’, copy available from here. The introduction to the draft explains: This guidance is intended to assist sponsors in obtaining a preliminary assessment from the FDA through the ‘Pre-Request for Designation’…

3 August 2017
FDA classifies certain post-amendment devices into Class II

The US Food and Drug Administration (FDA) has issued noticies in the Federal Register announcing that certain medical devices that fall under the definition of ‘post-amendment devices’ have been classified into Class II, Special Controls, following successful de novo 510(k) applications. The devices concerned are: Adjunctive Cardiovascular Status Indicator Oral Removable Palatal Space Occupying Device for…

2 August 2017
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