GLOBAL NEWS

As at the end of March 2023, there have been some further additions to the lists of Notified Bodies now designated under the MDR and IVDR. The latest additions are: MDR: 29 November 2022, Institute for Testing and Certification, Czech Republic 8 December 2022, ICIM, Italy 20 January 2023, SLG Pruf und Zertifizierungs, Germany 20…

A new Commission Implementing Regulation will soon be published to align the implementation timescale for the Common Specification (CS) on MDR Annex XVI products with the revised transition timescales for legacy devices covered in Regulation (EU) 2023/706. The full title of the new regulation as currently drafted is: “Regulation amending Commission Implementing Regulation (EU) 2022/2346…

The US Food and Drug Administration has published a final guidance document titled: ‘General Considerations for Animal Studies Intended to Evaluate Medical Devices: Guidance for Industry and Food and Drug Administration Staff’, available from here. The introduction to the guidance states: “This guidance document provides the FDA’s recommendations on animal studies intended to evaluate medical…

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its webpage referencing the EU’s publication of Amending Regulation (EU) 2023/607 on the extension of transition times for ‘legacy devices’ under the Medical Device Regulation (MDR, 2017/745) to advise that: “These extensions apply automatically in Northern Ireland. Certificates that have been extended will also…

Further to the acceptance of the European Parliament and Council of the Commission’s recommendations for extending the transition period of MDD ‘legacy devices’ under the MDR, the Commission has published a guidance document titled ‘Extension of the MDR transitional period and removal of the ‘sell off’ periods: Q&A on practical aspects related to the implementation…

Following last week’s formal approval of the European Commission’s proposal to extend the transition timelines for certain ‘legacy devices’ and eliminate the ‘sell-off period’ from the Medical Device Regulation (MDR, 2017/745) and the In Vitro Diagnostics Regulation (IVDR, 2017/746), Amending Regulation (EU) 2023/607 has now been published. The Preamble to the Regulation states, as industry…

In the UK Chancellor of the Exchequer’s budget statement on Wednesday 15 Marcy 2023, the potential future of medical device regulation was included. Based on an interim report from Sir Patrick Vallance, UK Government Chief Scientific Adviser, dated 8 March 2023, the Chancellor announced a commitment to some of the early outcomes of the ‘Regulatory…

Commission Delegated Regulation (EU) 2023/502 of 1 December 2022, which took on 11 March 2023, reduces the frequency of complete re-assessments of notified bodies from three years (1st complete re-assessment) and four years (following the 1st) to every 5 years in both cases; however, the competent authorities have the liberty to decide if complete re-assessment…

The European Council (EC) has approved a measure to extend the transition period for medical devices under the Medical Devices Regulation (MDR, 2017/745) and to remove the sell-off provisions for existing products as required under MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR, 2017/746). On 7 March 2023, the Council voted 27-0 to…

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…

One month after members of the European Council expressed support for delaying the Medical Device Regulation (MDR, 2017/745) transition period in a meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), the European Commission on 6 January 2023 adopted a proposal to allow medical device manufacturers more time to complete certification of…

The European Commission issued new guidance documents in December 2022 relating to both the Medical Device Regulation (MDR, 2017/745) and the In Vitro Diagnostic Regulation (IVDR, 2017/746), as follows: MDCG 2022-19: Performance study application/notification documents under Regulation (EU) 2017/746 MDCG 2022-20: Substantial modification of performance study under Regulation (EU) 2017/746 MDCG 2022-4 rev.1: Guidance on…

Maggie Fick, a reporter with Reuters.com, published an article titled ‘Medical device makers drop products as EU law sows chaos’ on 19 December 2022, commenting, quite accurately “A law created to stop one criminal company’s actions 10 years ago now endangers patients’ lives, including children, and European manufacturing sites. Is that what the EU wants…

The Life Sciences Council of the United Kingdom (UK) has today published a joint statement on a new agreement with other stakeholders, including UK industry representatives, to “accelerate the delivery of the future UK HealthTech regulatory system”. The statement, copy available from here, explains that “The reform of the UK’s Medical Device regulation offers a…

Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022, laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 (MDR) and Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of the MDR as regards reclassification of…

The European Commission intends to extend the transition period under the Medical Devices Regulation (MDR, 2017/745) for an additional three years. The proposal was raised at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council meeting on 9 December 2022 by the European Commissioner for Health, Stella Kyriakides, and supported unanimously by the member…

Although the proposals for easing the current regulatory burden on medical device manufacturers as a result of delayed implementation of the MDR announced on 9 December may go some way to avoiding the disappearance of many medical devices from the European market, German associations from various groups have expressed their concern in recent weeks. Spectaris,…

The US Food and Drug Administration (FDA) has issued a draft guidance document titled ‘Content of Human Factors Information in Medical Device Marketing Submissions: Draft Guidance for Industry and Food and Drug Administration Staff“ The draft is intended to be, when finalised, a companion guidance to document ‘Applying Human Factors and Usability Engineering to Medical…

The pan-European industry association for medical technology manufacturers, MedTech Europe, has developed and published an infographic to bring attention to its ‘Urgent call for action’ to European legislators to support high-level solutions to the delays, bottlenecks and other problems that have beset the introduction of the new Medical Device Regulations (MDR, 2017/745 and IVDR, 2017/746)….

The European Commission’s Medical Device Coordination Group (MDCG) has published a new guidance on Authorised Representatives under the Medical Device Regulations (MDR, 2017/745 and IVDR, 2017/746), replacing the January 2012 MEDDEV 2.5/10 ‘Guideline for Authorised Representatives’ which applied to authorised representation under the Medical Device Directives (MDD and IVDD). The new guidance is MDCG 2022-16…

At the 24 October meeting of the MDCG, some alarming, but not unexpected, details relating to notified body capacity in the run-up to the final days of implementation of the Medical Device Regulation (MDR, 2017/745) and the In Vitro Diagnostic Regulation (IVDR, 2017/746) were presented by the European Commission following a survey of notified bodies….

Is the European Commission at last listening to the MedTech industry as further delays and the lack of notified bodies threaten the final implementation stages of the new device regulations? In this context, the Medical Device Coordination Group (MDCG) published guidance document MDCG 2022-14, titled ‘Transition to the MDR and IVDR – Notified body capacity…

In a ‘letter to industry‘ dated 22 October 2022, the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), advised that it was implementing a 12-month extension to the current ‘standstill period’, mainly because additional time is needed to introduce the new medical device regulation that was initially planned to take effect from 1…

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has proposed that devices that aim to eliminate disparities in health care be designated ‘breakthrough products’. The agency is also considering expanding its criteria for breakthrough devices to include products that treat rare diseases, as well as non-addictive products to treat…

On 13 October, the European Commission’s Committee on Medical Devices voted on the draft Commission Implementing Regulation on the common specifications (CS) for groups of products without an intended medical purpose, as listed in Annex XVI of the Medical Device Regulation (MDR, 2017/745), copy available from here. The industry group representing manufacturers of these product…

TEAM-NB, the industry association for European notified bodies designated under MedTech regulations, has published a position paper titled ‘Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745 – Information to be supplied by the manufacturer – a collaborative notified body approach’. The 44-page document…

TEAM-NB, the industry association for medical device notified bodies, has published a number of new position papers in recent weeks, including: Transfer agreement template: specifying the terms of voluntary change of notified body under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 Data generated from ‘off-label’ use of a device under the EU Medical Device Regulation…

Now available from the Commission website are the following new guidance and informational documents: MDCG 2021-22 rev.1 – Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies MDCG 2022-13 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies MDCG 2022-14 – Transition to…

The US Food and Drug Administration has now published its revised user fees for its fiscal year (FY) 2023, which starts on 1 October 2022. Any submissions or applications arriving at the Agency on or after 1 October 2022 will need to have paid the new fees, which are: As can be seen from the…

The US Food and Drug Administration has published the final version of its guidance document ‘Clinical Decision Support Software – Guidance for Industry and Food and Drug Administration Staff’, available from here. Three years have passed since the Agency issued a draft of the document, to which many comments were received as a result of…

The European Commission has published the latest version of its Medical Device News Newsletter, available from here. Topics covered include: MDCG publishes a list of actions on notified body capacity and availability of medical devices and IVDs Common specifications for several types of high-risk diagnostics Guidance on harmonised administrative practices & alternative technical solutions EC…

Several recent additions have been added to the NANDO databases for Notified Bodies (NBs) designated under the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746). The latest assessment bodies to be designated are Bureau Veritas Italia and the Certification Division of the Spanish Agency for Medicines and Healthcare Products (AEMPS). 32…

The EC Medical Device Coordination Group (MDCG) has published a new guidance clarifying the requirements of Article 16 of the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostic Regulation (IVDR, 2017/746) relating to the circumstances under which EU importers and distributors of medical devices may be regulated as manufacturers. The guidance, MDCG 2021-26, ‘Questions…

An ad hoc task force of the EC Medical Device Coordination Group (MDCG) recently issued a report to the group clarifying many aspects of which transitional provisions in Article 120 of the Medical Device Regulation (MDR, 2017/745) would apply to so-called ‘legacy devices’. The report recommended that the MDCG accept the report as written and…

Italy has added another notified body (NB) to those now designated to operate under the EU Medical Devices Regulation (MDR, 2017/745), making a total of 24 available for use by device manufacturers, according to the NANDO website. Milan-based Certiquality, NB reference number 0546, is the latest to be added to the list of NBs designated…

The EU Commission has proposed an amendment to the transition of the In Vitro Diagnostic Regulation (IVDR, 2017/746) according to a press release and an accompanying Q&A webpage. In summary, the Commission has proposed that higher risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), have a transition…

The EC Medical Device Coordination Group (MDCG) has now published its guidance reference MDCG 2021-24, ‘Guidance on classification of medical devices’, to help manufacturers of devices regulated by the Medical Device Regulation (MDR, 2017/745) reach the correct conclusion about specific devices. The guidance follows the same format used for the preceding guidance relating to the…

The US Food and Drug Administration has now published its final rule on the de novo pathway for medical device clearance, clarifying the requirements for manufacturers whose devices may need to use the route in future. The 84-page final rule includes only minor changes from the 2018 draft rule. The pathway is used by manufacturers…

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…

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…

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…

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…

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…

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…

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…

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…

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:…

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…

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…

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,…

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…

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….

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…

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…

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….

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…

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…

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…

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…

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…

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…

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…

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…

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…

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.”…

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…

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…

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…

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),…

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…

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 …

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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.)…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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…

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….

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…

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,…

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…

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)….

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…

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…

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…

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…

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…

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…

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)…

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…

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…

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.

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…

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…

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…

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….

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….

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…

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…

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,…

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…

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…

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…

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…

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…

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…

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…

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…