EU Medical Devices Regulation: implementation progress during the pandemic
Although the date of application of the Medical Devices Regulation (MDR) has been delayed by a year, to May 2021, the EU institutions continue to work on its implementation to ensure that the new framework is workable in time for the revised deadline.
In this post, which is part of our series of blog posts covering the implementation of the MDR, we set out a summary of key recent developments. As indicated below, as well as our previous posts, there are several important steps that still need to be taken with regard to MDR implementation. Similarly, many companies are still working on their own compliance. While industry undoubtedly faces a range of challenges in the context of the ongoing health crisis, and the delay provides some welcome breathing room for many, it will nevertheless be important to continue to progress MDR preparedness so that supply is not disrupted.
Notified bodies designated under the Medical Devices Directive
As we have previously discussed, Regulation (EU) 2020/561 (which was adopted on 23 April) deferred the application of certain MDR provisions, and also deferred the date of repeal of the Medical Device Directives (MDD). This has had a significant impact on the designation of certain notified bodies under the MDD framework. While this amending Regulation allows MDD designated notified bodies to certify medical devices for one additional year – until 25 May 2021 – for some of these notified bodies, their designation under the MDD will expire before 25 May 2021. For this reason, the European Commission adopted, on 18 May 2020, an Implementing Regulation (EU) 2020/666 amending the rules on the renewal of designations and the surveillance and monitoring of notified bodies. This Implementing Regulation will allow designating authorities, in the context of the public health crisis, to derogate from the standard designation procedure in order to guarantee timely renewal of the designation before its expiry. It also provides for alternative surveillance and monitoring activities, that should be carried out by the designating authorities.
In addition, the Medical Device Coordination Group (MDCG) has developed a guidance document with the aim of ensuring consistency of the activities performed by the designating authorities. The guidance outlines the common criteria for the renewal of designation, and provides clarifications on the activities to be performed by the designating authorities.
Regarding the progress of notified bodies designations under the MDR and IVDR, there are at the time of publication 14 notified bodies listed in the European Commission’s NANDO information system for the MDR (two more than in March) and four for the IVDR. These numbers are expected to progress in the near future, however, COVID-19 creates significant issues in relation to this process as many actors are involved, i.e., different European Commission services and national authorities. In addition, notified bodies designation under the MDR has proven to be a difficult task for the European Commission which was initially anticipating to have 20 notified bodies MDR designated by the end of 2019. Therefore, the pandemic is only adding more concerns to this situation where many devices have to get through the books.
Safety reporting in clinical investigations
The MDCG has also recently endorsed a guidance document, explaining how safety reporting should be performed for clinical investigations of medical devices under the MDR, and until the European database on medical devices (EUDAMED) is fully functional. The guidance document sets out the procedures for safety reporting in the absence of EUDAMED, including information on reporting methods, reportable events, reporting parties and timelines. To facilitate safety reporting activities under the MDR, a template Clinical Investigations Summary Safety Report Form is also provided alongside the guidance.
The European Commission has pledged, in agreement with the MDCG, to gradually make the different modules of EUDAMED available as soon as they are functional.
EU-wide derogations regarding conformity assessment and market surveillance procedures
As we have previously discussed (here and here), Article 59 of the MDR allows, under special circumstances, national competent authorities to authorise the placing on the market of medical devices for which the relevant conformity assessment procedures have not been carried out. Furthermore, Article 59 provides the European Commission with the ability to extend national derogations EU-wide. After the recommendation of the European Commission, on 13 March 2020, to make use of these derogations in the context of COVID-19 crisis, Article 59 has now been amended by Regulation (EU) 2020/561, to cover derogations both under the MDR and the MDD framework.
Following the amendment, the European Commission has published guidelines on the adoption of EU-wide derogations permitted under Article 59 of the MDR. These guidelines set out the criteria to be taken into account to determine the extension of national derogations at the EU level, as well as a description of the process to be followed. EU-wide derogations will be adopted by the European Commission by means of implementing acts. It is hoped that this flexibility will mean products that are important for addressing our current health crisis can reach patients quickly, while maintaining oversight by the authorities.
Other guidance
Two Q&A documents were published by the European Commission in May. The first Q&A document provides guidance to companies to adapt their IT system to the new Manufacturer Incident Report Form used for reporting incidents in the context of medical device vigilance systems.
The second Commission Q&A document provides information of a general nature on how to verify that medical devices and personal protective equipment can be lawfully placed on the EU market. This document is principally addressed to persons who have only recently become involved with these activities, due to the COVID-19 crisis, and are unfamiliar with medical devices and personal protective equipment regulation.
The European Commission has also updated its timeline for endorsement of various guidance documents under development by MDCG subgroups. According to the updated list, most MDCG guidance documents are expected to be endorsed by the end of this year. However, several guidance documents appear without a specified timeline, and the guidance on devices listed in Annex XVI (that do not have a medical purpose, but are still subject to the MDR) is expected in 2021. The COVID-19 crisis is understandably leading to delays in the development of these guidance documents as their discussion and endorsement normally takes place in Brussels under the supervision and coordination of the European Commission. However, according to a recently published document by the European Commission, upcoming meetings of the MDCG and subgroups will take place by videoconferences, at least until this summer, with the aim of maintaining these timelines.
Implementation rolling plan updated
On 6 June, the European Commission updated its implementation rolling plan, which contains information on the progress of implementing acts and actions that the Commission is planning to adopt, plus an update of the expected timelines. Implementing acts due to be adopted in the near future (Q3 2020) include those that concern reprocessing of single-use medical devices and setting up of expert laboratories.