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Eudamed update

According to the Eudamed webpage, a significant upgrade will be installed over the period from 30 September and 4 October 2021, and users are advised not to try and access the system during this time, but to wait until a confirmation of upgrade completeness is published on the same webpage. The notice warns that the…

30 September, 2021
Borderline and classification case process updated

To allow consultation among competent authorities (CAs) on borderline and classification issues concerning medical devices, and to ensure that appropriate guidance is published in the Manual on Borderline & Classification for Medical Devices (the Manual), the Borderline & Classification Working Group (BCWG) of the Medical Devices Coordination Group (MDCG) has updated the ‘Helsinki Procedure’ first…

27 September, 2021
Commission issues September 2021 Medical Device Newsletter

The European Commission has published the September 2021 copy of its Newsletter for Medical Devices, copy obtainable from here. The Newsletter covers, among other topics: A webinar for patients Launch of a UDI Helpdesk Transitional provisions for IVD certification Q&A for specific combinations of medicinal products and medical devices Rules for Eudamed registration Identification numbers…

24 September, 2021
UK consultation on future device regulation published

The UK government, via the Medicines and Healthcare products Regulatory Agency (MHRA) has now published its consultation on the future regulation of medical devices in the UK. The MHRA webpage introducing the consultation is available from here, and the consultation questionnaire itself is accessible here. As background, the current 2021 version of the 2002 device…

17 September, 2021
UK Government consults on use of phthalates in medical devices

The UK Department for Environment, Food and Rural Affairs (DEFRA) is inviting responses to a consultation seeking views on extending the restrictions on the use of four phthalates in medical devices, monitoring and control equipment in Great Britain (GB). “We want to know what you think about a proposed restriction on the use of 4…

16 September, 2021
Industry again warn Commission of potential for IVD shortages

MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health, ran a survey in July 2021 to gather data from IVD manufacturers on the state of the IVD market today and how they are expected to transition to the IVD Regulation within ten months from the survey…

11 September, 2021
EN ISO 13485 now linked to MDR/IVDR

CEN has now published EN ISO 13485:2016+A11:2021, ‘Medical devices – Quality management systems – Requirements for regulatory purposes’, adding Annex Zs to the already published standard. It is expected that the European Commission will add EN ISO 13485:2016+A11:2021 to the slowly growing list of standards harmonized under the Medical Device Regulation (MDR, 2017/745) and the…

3 September, 2021
Notified Body numbers update

Between 1 July 2021 and 1 September 2021, the following notified bodies (NBs) have been added to the lists of NBs available for operation under the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746), according to the NANDO database: TÜV Rheinland Italia (23rd NB under the MDR) GMed SAS (6th NB…

2 September, 2021
MDCG issues new guidance for importers and distributors under MDR/IVDR

MDCG 2021-23 is a new guidance document published by the Medical Device Coordination Group (MDCG) addressed to importers and distributors of medical devices on the requirements in Article 16 of the regulations. Article 16 is headed ‘Cases in which obligations of manufacturers apply to importers, distributors or other persons’, and apply in cases such as:…

28 August, 2021
MedTech Europe responds to Proposal for an Artificial Intelligence Act

MedTech Europe (MTE), the European trade association representing the medical technology industry including diagnostics, medical devices and digital health, has provided its response to the European Commission’s adoption consultation on the proposed Artificial Intelligence Act (AIA). The Association comments that: “Artificial Intelligence (AI) technology is increasingly used in healthcare and in recent years has been…

16 August, 2021
FDA advises new fees for FY 2022

The US Food and Drug Administration has now published its revised user fees for its fiscal year (FY) 2022, which starts on 1 October 2021. Any submissions or applications arriving at the Agency on or after 1 October 2021 will need to have paid the new fees, which are:

4 August, 2021
EMA issues guidelines for combination products

The European Medicines Agency (EMA) has published a new guidance document, titled ‘Guideline on quality documentation for medicinal products when used with a medical device’, providing advice on the quality information that manufacturers of combination products should submit in marketing authorization applications (MAA) to the Agency. The guideline also incorporates the recent revision of the…

28 July, 2021
First standards harmonised under MDR/IVDR

In only a trickle rather than the desired flood, the first five standards to be harmonised under the MDR and IVDR have been published in the Official Journal of the European Communities (OJEC). Four of the standards are identified for both MDR and IVDR, covering sterilization, and one has been identified for medical devices only,…

26 July, 2021
IMDRF publishes guidance on Conformity Assessment Body Assessment Process

The International Medical Device Regulators Forum (IMDRF) has published guidance document WG/N66FINAL:2021, titled ‘Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews’. The document explains the assessment process and outcomes, including the method to “grade and manage” nonconformities resulting from a recognizing Regulatory Authority’s assessment of a…

23 July, 2021
MDCG publishes guidance on integration of UDI and QMS

MDCG 2021-19, ‘Guidance note integration of the UDI within an organisation’s quality management system’, has now been published by the Medical Device Coordination Group (MDCG), detailing its advice on how, when implementing the requirements of the MDR/IVDR related to its QMS, manufacturers should consider how the UDI system and related MDR/IVDR obligations should be integrated….

18 July, 2021
FDA finalizes long-awaited UDI guidance

The US Food and Drug Administration (FDA) has now finalized its guidance on requirements for unique device identifiers (UDI), nearly five years after releasing its draft guidance and eight years after issuing the UDI final rule. FDA said the final guidance is intended to describe “the requirements for, and FDA’s recommendations regarding, the form and…

14 July, 2021
MedTech Europe “remains sceptical” of future HTA regulation

MedTech Europe – the European trade association for the medical technology industry including diagnostics, medical devices and digital health – has provided rapid feedback on the decision by the Council of the European Union, to endorse the text of the future Regulation on Health Technology Assessment (HTA). MedTech Europe comments that: “Our industry supports EU…

9 July, 2021
MDCG updates Q&A guidance on Eudamed registration of non-economic operator actors

MDCG 2021-13 rev.1, ‘Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR’, has now been published by the Medical Device Coordination Group (MDCG), adding a further question to the document….

6 July, 2021
Swissmedic issues statement on becoming a ‘third country’

Swissmedic, the medtech competent authority in Switzerland, issued a statement on 26 May 2021, titled ‘Modification of the Medical Devices Ordinance (MedDO) in the context of pending agreements between Switzerland and the EU’, which read, in part: “On 19 May 2021, the Federal Council approved supplementary provisions to the implementing regulations on medical devices. These…

30 May, 2021
Post-market issues covered by two new draft guidelines from FDA

The US Food and Drug Administration (FDA) has published two new draft guidance documents for public comment before 26 July 2021. The first is titled ‘Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry and Food and Drug Administration Staff’, available from here. This draft explains that…

30 May, 2021
Commission launches Unique Device Identification (UDI) Helpdesk

Unique Device Identification (UDI) requirements have been introduced under Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which become applicable from 26 May 2021 and 26 May 2022 respectively. The UDI system enhances the identification of medical devices and makes it easier to trace them when…

20 May, 2021
EMA reissues Q&A guidance on drug-device combination consultation process

The European Medicines Agency has updated its 2015 Question and Answer guidance document on the combination product consultation procedure to align its content with the requirements of the Medical Device Regulation (MDR, 2017/745). The document has the catchy title of ‘Questions & Answers on the consultation procedure to the European Medicines Agency by notified bodies…

9 April, 2021
Twenty NBs now designated for MDR

Eurofins Expert Services Oy, located in Finland, has become the twentieth Notified Body (NB) to be designated under the EU Medical Device Regulation (MDR, 2017/745) according to the NANDO database. Eurofins is Notified Body number 0537 and remains designated under the Medical Device Directive (MDD, 93/42/EEC) and In Vitro Diagnostics Directive (IVDD, 98/79/EC). The European…

9 April, 2021
FDA adds ‘resource center’ webpage for biocompatibility assessment support

The US Food and Drug Administration (FDA) has launched a new webpage aimed at providing support and advice to medical device manufacturers on the steps needed to demonstrate device biocompatibility in submissions to the Agency. The website introduces the subject by stating: “These resource pages are intended to explain terms and concepts important for the…

19 March, 2021
MDCG publishes Q&A guidance on custom devices

The European Commission’s Medical Device Coordination Group (MDCG) has issued a new guidance in the form of a Q&A document, introduced as being a “high-level document aimed at addressing the most pertinent questions relating to custom-made devices falling under Regulation (EU) 2017/745 on medical devices (MDR)”. The document is titled MDCG 2021-3 ‘Questions and Answers…

18 March, 2021
FDA Seeks Volunteers for Progress Tracker for Premarket Submissions

The US Food and Drug Administration (FDA) is building a secure, web-based tracker that displays the Center for Devices and Radiological Health’s progress on medical device submissions focused on premarket review. The progress tracker is the first feature of a larger platform to help FDA collaborate with the medical device industry. FDA is currently seeking…

10 March, 2021
New irritation test standard published by ISO

The International Standardisation Organisation (ISO) has now published a new standard in the biocompatibility series ISO 10993 that specifies the use of laboratory-grown skin for irritation testing, as an option to animal testing. The new standard is ISO 10993-23:2021, titled ‘Biological evaluation of medical devices — Part 23: Tests for irritation’, which replaces the irritation…

8 March, 2021
MDCG issues guidance on life without Eudamed

The Medical Devices Coordination Group (MDCG) has published a 31-page document, MDCG 2021-1, titled ‘Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional’. Interestingly, the first page states: “The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission.”…

5 March, 2021
Commission issues guidance on Management of Legacy Devices

The European Commission has published a new guidance document titled ‘Management of Legacy Devices, MDR EUDAMED‘, explaining “how Legacy Devices will be identified in EUDAMED and the way the different Unique Device Identifiers for the Legacy Devices will be generated/assigned”. The document clarifies that “Legacy Devices are defined as Medical Devices, Active Implantable Medical Devices…

19 February, 2021
Two new Notified Bodies designated under MDR

The number of Notified Bodies cleared to offer services in accordance with the Medical Device Regulation (MDR, 2017/745) continues to creep up, with two more companies being identified on the NANDO database since the beginning of the year, these being: SGS Fimko OY, Finland, and Istituto Superiore di Sanita (ISS), Italy The number of Notified…

17 February, 2021
Canada updates standards recognition list and PMS rules

Health Canada has recently updated its list of recognised standards to include 14 new standards, the replacement of 29 standards with newer editions, and the removal of three standards. Stakeholders have until 16 March 2021 to comment on the revised list. In addition, Health Canada is reminding companies that its rules on post market surveillance…

23 January, 2021
Commission announces members of initial Expert Panels

The European Commission has released the names of members appointed to its 12 expert panels on medical devices and in vitro diagnostics (IVDs). The expert panels, established under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), will provide scientific, technical and clinical input to the Commission, its Medical Device Coordination Group (MDCG),…

15 January, 2021
Commission issues official Notice regarding virtual audits

As a result of the Covid-19 pandemic, device manufacturers preparing for compliance with the Medical Device Regulation (MDR, 2017/745) have suffered delays with notified body audits, because of travel restrictions. The Commission has therefore decided to allow ‘virtual audits’ under certain conditions, and has published a ‘Commission Notice‘ in the Official Journal to set out…

14 January, 2021
FDA introduces final guidance on the STeP program

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 …

11 January, 2021
Health Canada introduces PMS requirements for devices

Health Canada has written to all Medical Device Licence holders and Medical Device Establishment Licence (MDEL) holders in relation to the introduction of post-market surveillance requirements that amend the Medical Devices Regulations, as published in the Canada Gazette, Part II (Vol. 154, No. 26). Health Canada explains that the changes have been made “to strengthen…

24 December, 2020
FDA updates its Recognized Consensus Standards list

The US Food and Drug Administration (FDA) has added or updated nearly 100 voluntary consensus standards to its list of recognised standards for medical devices, available via its standards database search page. The updated standards include a number from the IEC 60601 series, including references to consolidated versions of: IEC 60601-1-2 IEC 60601-1-6 IEC 60601-1-8…

23 December, 2020
HPRA revises its guide for medical device distributors

The Irish Competent Authority for medical devices, the Health Products Regulatory Agency (HPRA) has updated its guidance for medical device distributors, making it relevant to compliance with the Medical Devices Regulation (MDR, 2017/745) rather than the Medical Device Directive (MDD, 93/42/EEC). The guidance is published in ‘redline version’, so the changes from the previous version…

20 December, 2020
New Notified Bodies appear on NANDO website

18 Notified Bodies are now listed on the NANDO website for medical devices falling under the Medical Device Regulation (MDR, 2017/745) and 5 are now listed for the In Vitro Diagnostics Regulation (IVDR, 2017/746). These numbers are still well short of the number needed to cope with the anticipated influx of requests to Notified Bodies…

19 December, 2020
FDA will launch pre-market submission tracker pilot in January 2021

The US Food and Drug Administration (FDA) has announced that it will be carrying out a ‘soft launch’ of a real-time tracking system for pre-market submissions in January 2021. FDA committed to providing a submission tracker in its MDUFA commitments to the medical device industry, so during the January 2021 soft launch, the submission’s Official…

12 December, 2020
MDCG issues guidance on In Vitro Diagnostic Classification Rules

The European Commission’s Medical Device Coordination Group (MDCG) has published long-awaited guidance, MDCG 2020-16, that explains how to classify products for compliance with the EU’s In Vitro Diagnostics Regulation (IVDR, 2017/746). The IVDR is replacing the classification system from the In Vitro Diagnostics Directive (IVDD, 98/79/EC) with a risk-based system, which will require the reclassification…

11 December, 2020
MHRA provides post-Brexit device registration details

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published on its website full details of how the device registration system for the UK will operate post-Brexit, from 1 January 2021. As already known, only UK entities will be allowed to make the device registrations, these being either UK device manufacturers, UK Responsible Persons…

7 December, 2020
IVDR implementation – TEAM-NB steps in

Team-NB (the European association of notified bodies) has published a position paper on the IVD Regulation (2017/746) date of application, indicating that their member Notified Bodies would support maintaining the current May 2022 date of application, provided that the following conditions are met by the end of 2020: The tools necessary to perform conformity assessments…

27 November, 2020
FDA explains its ‘Catalog of Regulatory Science Tools’ to help assess new device technologies

The catalog collates a variety of regulatory science tools that the FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) developed and plans to expand as new tools become available. “These tools expand the scope of innovative science-based approaches to help improve the development and assessment of emerging medical…

24 November, 2020
FDA issues draft guidance on electromagnetic compatibility data in device pre-market submissions

Sponsors of medical devices that are electrically powered or have electronic circuitry need to include 11 categories of safety information in their premarket submissions, the US Food and Drug Administration (FDA) has said in a draft guidance document intended to replace the Agency’s 2016 guidance on electromagnetic compatibility of devices. The guidance applies to submissions…

18 November, 2020
MedTech Europe introduces new IVDR labeling symbols

Under the IVDR (2017/746) manufacturers will need to state on their labels when the device is intended for self-testing or for near-patient testing, and for certain rapid tests when they are not intended for self-testing nor for near-patient testing. MedTech Europe (MTE) wants to make this more effective by providing industry with agreed symbols for…

7 November, 2020
IMDRF progresses key device documents at virtual meeting

The International Medical Device Regulators Forum (IMDRF) made further progress towards global harmonization of device standards at its most recent meeting, held for the first time as a virtual conference due to COVID-19 restrictions. Among other actions at the September meeting, hosted by Singapore, IMDRF approved the final draft of a document on conformity assessment…

24 October, 2020
Donawa Lifescience opens GB company to provide UKRP services

Donawa Lifescience Consulting (DLC), headquartered in Rome, Italy, has announced the opening of a company in Great Britain (GB), Donawa Lifescience Ltd., to provide non-UK companies with ‘United Kingdom Responsible Person’ (UKRP) services as an easy initial pathway to the post-Brexit medical device market in Great Britain. Following the publication of the UK Medicines and…

23 October, 2020
UK government publishes further draft of the post 2020 device law

The UK government has published a further set of draft amendments to the Medical Devices Regulations 2002 (as previously amended), for which a draft amendment was published in late 2019 (the ‘Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019’), but which has now been further amended in ‘The Medical Devices (Amendment etc.)…

22 October, 2020
Multiple guidance documents issued for Eudamed ‘Actor Registration’

The European Commission has published a number of guidance documents related to how manufacturers, authorised representatives and importers (‘economic operators’) will be able to access and register with the ‘actor registration’ module of Eudamed from 1 December 2020. A new webpage has been set up within the Eudamed website, relating only to the actor registration…

21 October, 2020
FDA issues draft guidance on exclusion of certain materials from biocompatibility testing

The US Food and Drug Administration (FDA) has published draft guidance to propose select updates to its biocompatibility recommendations, to assist manufacturers in preparing premarket approval applications (PMAs), humanitarian device exemption (HDE) applications, investigational device exemption (IDE) applications, premarket notification (510(k)) submissions, and De Novo classification requests for medical devices that come into direct contact…

20 October, 2020
EC Issues Guidance on Vigilance System for Insulin Infusion Pumps

The European Commission has released guidance for manufacturers of insulin infusion pumps and integrated-meter systems to spell out the reporting requirements under the EU’s Medical Device Regulation (MDR, 2017/745). The guidance, reference DSVG 05, ‘Guidance on the vigilance system for CE-marked medical devices: Insulin Infusion Pumps and Integrated meter systems’, outlines specific scenarios that should…

16 October, 2020
MDR update

Progress has been made on several fronts in relation to the roll-out of regulations and guidance for the Medical Device Regulation (MDR, 2017/745) in recent weeks. Firstly, the 16th and 17th MDR Notified Bodies have been named on the NANDO database, these being DQS Medizinprodukte GmbH, Germany, making it the sixth Notified Body to be…

16 September, 2020
MHRA publishes information on UK post-Brexit device regs

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published in its website an overview of the post-Brexit regulations that will apply to medical devices in the event of a ‘no deal’ or ‘hard’ Brexit. It confirms that the UK will leave the European Union (EU) on 31 December 2020, and so the new…

14 September, 2020
Brexit and MDR present double whammy for UK MedTech

Two reports do not provide easy reading for UK MedTech, as the government warns about post-Brexit device shortages and a survey finds UK SMEs still unprepared for the MDR, despite having an extra year to prepare, thanks to the coronavirus. In a letter to suppliers, Steve Oldfield, Chief Commercial Officer at the Department of Health…

18 August, 2020
FDA announces user fees for fiscal 2021

The US Food and Drug Administration (FDA) has announced the user fees that will apply to medical devices from 1 October 2020 until 30 September 2021. The fees will be:                       † For small businesses with an approved SBD. ‡ Note: all types of 510(k)s…

12 August, 2020
FDA publishes first device-specific safety and performance pathway guidelines

More than two years after the US Food and Drug Administration (FDA) first proposed an alternate safety and performance based pathway for certain well-understood medical devices, the agency has finalized the first two device-specific guidelines establishing performance criteria to support 510(k) clearance via the new pathway. The two final guidelines provide performance criteria for cutaneous…

10 August, 2020
EC launches new Medical Devices website

The European Commission has launched a new Medical Devices website, hosted on the portal of the Directorate-General for Health and Food Safety (DG SANTE). The website contains information and advice for all stakeholders in the medical devices and in vitro medical devices value chain with respect to their roles and responsibilities within the context of…

28 July, 2020
FDA issues final order exempting certain devices from 510(k) requirements

Five distinct device types will no longer require premarket notification (510(k)s) to the US Food and Drug Administration (FDA) according to a final order issued by the agency. The following five device types were identified in the 22 July 2020 edition of the Federal Register: Assisted reproduction accessories (assisted reproduction laminar flow workstations); Reproductive media…

24 July, 2020
Third standards mandate ready by Q1 2021, says Commission

Following two failed attempts to have its standards mandate for the Medical Devices Regulation (MDR, 2017/745) accepted by the European standards bodies CEN and CENELEC, the European Commission has indicated that a third mandate will be issued during the first quarter of 2021. The new date has been included in the recently updated Joint Implementation…

20 July, 2020
MDCG clinical evaluation assessment report (CEAR) guidance published

Notified bodies use a clinical evaluation assessment report (CEAR) to clearly document the conclusions of its assessment of the clinical evidence presented by medical device manufacturers in clinical evaluation reports (CERs) and associated documentation. The assessment of clinical evidence is a core requirement of the Medical Device Regulation (MDR, 2017/745). Use of a harmonised CEAR…

20 July, 2020
FDA issues final guidance on transition to eSubmissions

The US Food and Drug Administration (FDA) has committed to a phased move to electronic submissions of medical device regulatory filings in final guidance now published. The final guidance, published on 15 July 2020, closely follows the draft version released for consultation in September 2019. One of the main changes is the addition of a…

17 July, 2020
GMED becomes France’s first MDR Notified Body

GMED has been designated as a Notified Body under Regulation (EU) 2017/745, Medical Device Regulation (MDR), by the French National Agency for Medicines and Health Products Safety (ANSM). It is the first for France, and the 15th in total for the MDR. To complement its MDR designation, GMED states on its website that it “is…

12 July, 2020
MedTech Europe Calls for Allowing Virtual Audits by Notified Bodies

MedTech Europe is asking the European Commission and EU member states to release guidance clarifying that notified bodies may conduct audits virtually in place of on-site audits during the pandemic for new devices and in-vitro diagnostics. The group stressed in a new position paper that going forward the scope of the virtual audits should not…

5 July, 2020
MDCG publishes new guidance on transitional provisions for MDR consultations

The European Medical Devices Coordination Group (MDCG) has just published a new guidance document titled ‘Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal…

18 June, 2020
IVDR gets fourth notified body

The NANDO website for the In Vitro Diagnostics Regulation (IVDR, 2017/746) has at long last reported an increase in the number of notified bodies designated to act under this regulation, from three to four. The latest addition is TÜV SÜD Product Service GmbH Zertifizierstellen, Germany, notified body reference number 0123. Although the date of application…

18 June, 2020
Commission confirms availability of EUDAMED modules

The European Commission website page devoted to EUDAMED has now been updated to provide information on when the first modules of the system needed to support the new device regulations will be available for the various actors to use on a voluntary basis. The webpage explains that: The development and implementation of EUDAMED is a…

12 June, 2020
MedTech Europe publishes a statement, two guidelines and a position paper

The pan-European industry association MedTech Europe has published four documents in recent days to assist device manufacturers navigate the coronavirus pandemic and the transition to compliance with the new regulations (MDR, 2017/745 and IVDR, 2017/746). The statement relates to the potential for clinical investigations, including post-market clinical follow-up (PMCF) studies needed for recertification purposes, to…

11 June, 2020
Implementing Regulation (EU) 2020/666 eases burden on AIMDD/MDD continued compliance

On 18 May 2020, the European Commission published in the Official Journal of the European Communities ‘Implementing Regulation (EU) 2020/666 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies’. The 920/2013 regulation detailed “a common interpretation of the main elements of the criteria for…

24 May, 2020
Standardisation mandate now sent to CEN/CENELEC

The European Commission has now published the standardisation mandate for the harmonisation of standards under the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746) in the European Standards section of the Commission website. The mandate is titled: ‘M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the…

20 May, 2020
BfArM and DIMDI to merge

On the 26th May 2020, DIMDI and the Federal Institute for Drugs and Medical Devices (BfArM) will join to become one agency, “to better prepare for the future”, according to the German Federal Minister for Health. Once DIMDI is merged into BfArM, the DIMDI name will no longer be used after 50 years of operation….

20 May, 2020
Two new guidelines from European Commission, plus latest consolidated MDR text

The European Commission has published two new guidance documents on its website in addition to making available an up-to-date consolidated version of the Medical Device Regulation (MDR, 2017/745). The new guidance documents are: MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745, and Communication from the Commission: Guidelines on…

20 May, 2020
Swedish Notified Body becomes number 14

Intertek Medical Notified Body AB has become the 14th Notified Body to be designated under the Medical Device Regulation (MDR, 2017/745) and the first from Sweden. Intertek Sweden has NB reference number 2862, according to the NANDO website. No further NBs have been added to the NANDO list for the In Vitro Diagnostics Regulation (IVDR,…

16 May, 2020
ISO/TR 20416:2020 on PMS published

The International Standards Organisation (ISO) has now published Technical Report ISO/TR 20416, ‘Medical devices – Post-market surveillance for manufacturers’. The ‘Scope’ of the document explains: “This document provides guidance on the post-market surveillance process and is intended for use by medical device manufacturers. This post-market surveillance process is consistent with relevant international standards, in particular…

7 May, 2020
MDR delay Regulation published

The Official Journal of the European Communities (OJ) has now published ‘Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices [MDR], as regards the dates of application of certain of its provisions’, confirming a 12-month delay to the Date of Application (DoA)….

27 April, 2020
IMDRF issues new final guidance documents

The International Medical Device Regulators’ Forum (IMDRF) issued four new or revised final guidance documents on 20 April 2020, these being: Principles and Practices for Medical Device Cybersecurity Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews Personalized Medical Devices – Regulatory Pathways IMDRF terminologies for categorized Adverse Event Reporting…

25 April, 2020
FDA finalizes medical device post-inspection feedback guidance

The US Food and Drug Administration (FDA) has finalised guidance on how medical device manufacturers can request nonbinding feedback on proposed actions to address issues raised during QSR inspections. Specifically, the eight-page guidance addresses Section 702 of the FDA Reauthorization Act of 2017 (FDARA), which calls on FDA to improve its inspection process for device…

24 April, 2020
MDCG publishes multiple guidelines from CIE group

The EU Medical Devices Coordination Group (MDCG) has just published new and revised guidance documents from the Clinical Investigation and Evaluation (CIE) Working Group on its ‘MDCG endorsed documents‘ webpage. The new guidelines are: MDCG 2020-5 Guidance on Clinical Evaluation – Equivalence MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices MDCG 2020-7 Guidance on PMCF Plan…

24 April, 2020
Commission publishes document on ‘Current performance of COVID-19 test methods and devices’

The European Commission has published a ‘Working Document of Commission Services’ to address issues surrounding the ‘Current performance of COVID-19 test methods and devices and proposed performance criteria’. The 32 page document Executive Summary explains that: “When assessing conformity with the legislation and prior to affixing the CE-mark, the manufacturer must evaluate the performance of…

23 April, 2020
12-month MDR delay confirmed by EP

On Friday 17 April 2020, the European Parliament and Council approved the Commission’s proposal to delay the Date of Application (DoA) of the Medical Device Regulation (MDR, 2017/745) by 12 months, to 26 May 2021. The result of the vote in the Parliament was 693 in favour, 1 against, and 2 abstentions. The next stage…

19 April, 2020
Commission MDR delay proposal published – update

Following its 25 March announcement that it would make a proposal for delaying the Medical Device Regulation (MDR, 2017/745) by 12 months, the European Commission has (ironically) wasted no time in publishing its “Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the…

9 April, 2020
Guidance on ‘virtual audits’ published by Commission

The European Medical Device Coordination Group (MDCG) has now published a guidance document relating to how Notified Bodies will be allowed to continue conducting audits under the medical device directives during the coronavirus crisis, which has seen many countries restrict travel and issue ‘stay at home’ orders, although the document states that “for Regulations (EU)…

9 April, 2020
Commission proposing a 12 month delay to MDR

At the same time that the device industry is finalising a paper to send to the European Commission to delay the date of application of the Medical Device Regulation (MDR, 2017/745) until at least six months after the Covid-19 pandemic is over, the Commission itself announced it will be proposing a 12-month delay as a…

26 March, 2020
Commission publishes updated lists of harmonised standards for Directives

The Official Journal (OJ) of the European Communities of 26 March 2020 includes Council Decisions and lists of standards that have now been ratified by the European Commission as ‘harmonised standards’, conferring ‘presumptions of conformity’ with the applicable Essential Requirements of the three device directives, these being: Medical Device Directive (MDD, 93/42/EEC) Active Implantable Medical…

26 March, 2020
MTE calls for Commission to delay MDR due to Covid-19

The European medical technology industry association, MedTech Europe, has issued a press release calling on the European Commission to delay the date of application of the Medical Device Regulation (MDR, 2017/745) until six months after the Covid-19 pandemic is officially over. A copy of the press release can be obtained from here.

23 March, 2020
13th MDR Notified Body announced

The NANDO database now includes the name of CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. as the 13th Notified Body (NB) designated under the Medical Device Regulation (MDR, 2017/745). CE Certiso is based in Hungary and has the NB reference number 2409. No further NBs have been added to the NANDO list for…

23 March, 2020
Is the MDCG guidance on ‘significant changes’ misinterpreting the MDR?

The Commission has recently published document reference MDCG 2020-3, ‘MDCG guidance on significant changes in the context of MDR Article 120’, but has it made a fundamental error in its understanding of the MDR wording, or is it a deliberate (mis)interpretation? MDR Article 120(3) states: “. . . provided there are no significant changes in…

22 March, 2020
Recent MDR updates from Commission

The European Commission has recently published a number of revised or new documents, as follows:. An updated Joint Implementation/Preparedness Plan on the Medical Devices Regulation (MDR, 2017/745); The long-awaited guidance document MDCG 2020-3 ‘MDCG guidance on significant changes in the context of MDR Article 120‘; MDCG 2019-8 v2: Guidance document: ‘Implant Card relating to the…

21 March, 2020
TEAM-NB issues Position Paper on dental implants and abutments under MDR

Team-NB, the European Association of Notified Bodies for Medical Devices, has released a position paper making a proposal for dental implants and dental implant abutments to be considered as ‘exempted implants’ under the Medical Device Regulation (MDR, 2017/745). The MDR defines specific requirements for implantable devices, placing them in one of the higher risk classes….

16 March, 2020
Three more NBs announced for MDR

During the last month, three more notified bodies have been added to the NANDO listing for the Medical Device Regulation (MDR, 2017/745), these being: DNV GL Presafe AS (NB#2460) Norway on 6 February 2020; National Standards Authority of Ireland (NSAI) (NB#0050) on 13 February 2020; and DEKRA Certification B.V., (NB#0344) Netherlands on 6 March 2020….

8 March, 2020
MHRA shelters orphaned manufacturers

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has moved to offer a degree of protection for companies whose situation has been compromised by the withdrawal of their notified body from the medical device sector at short notice. In the absence of any specific provisions under the current legislation regarding the ongoing validity of…

6 March, 2020
Brexit transition brings short-term device regulatory stability

As the long road to the UK’s formal withdrawal from the EU came to an end, this signalled a degree of regulatory certainty at least in the UK until the end of the transition period on 31st December 2020. During this period the UK will remain aligned with EU law, and the current rules on…

4 March, 2020
PIP case rolls on through the courts

On the 27 February 2020, the German Federal Court of Justice ruled on the legal requirements of liability for the Notified Body linked to the case of patients suffering from damages related to the silicone breast implants manufactured by the French company Poly Implant Prothèse (PIP). The Court concluded that there was no contractual liability,…

3 March, 2020
Spain to allow more time for post-Brexit labelling changes.

The Spanish Agency of Medicines and Medical Devices medical device authorities (AEMPS) have published a notice indicating that companies will have until the end of June 2021 to change labels and instructions for use should the UK leave the EU without a deal at the end of the transition period on 31 December 2020. This…

25 February, 2020
Swiss MRA in jeopardy

The national association for medical technology companies in Switzerland, Swiss Medtech, has issued a warning to manufacturers of the consequences of the potential failure of the Mutual Recognition Agreement between the EU and Switzerland. According to Swiss Medtech, since last December the EU lawyers have been interpreting the MRA “in the most unfavourable way for…

22 February, 2020
MHRA Updates Guidance on Clinical Investigations for Devices

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance titled ‘Notify MHRA about a clinical investigation for a medical device‘ for study sponsors on notifying the agency about clinical investigations to support a CE Mark. The guidance covers the following topics: How to notify MHRA of your clinical investigation In Vitro Diagnostic…

31 January, 2020
MDR/IVDR Second Corrigenda published

The second corrigenda for the European Medical Devices Regulation (MDR, 2017/745) and In Vitro Device Regulation (IVDR, 2017/746) were published in the Official Journal of the European Union on 27 December 2019, although the ‘New Regulations‘ page of the Commission website has not yet been revised to indicate their availability. The MDR corrigendum is available…

18 January, 2020
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
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