Four-Year Transitional Period Expected for Certain Low-Risk Devices Including Software Under Changes to EU Medical Devices Regulation

With the year coming to an end and the application of the Medical Devices Regulation (MDR) less than six months away, now is a good time to reflect on the status of its implementation.

• This week, the Council of the European Union took a step towards granting much-needed relief for manufacturers of certain low-risk medical devices by publishing a draft second corrigendum to the MDR (draft Corrigendum No. 2, available here). The draft Corrigendum No. 2 proposes a four-year transitional period for certain Class I devices that would be moved into a higher-risk class under the MDR.
• The European Commission (Commission) also continues its seemingly endless work towards ensuring a proper implementation of the MDR, issuing new guidelines on a regular basis.
• The current small number of MDR-designated Notified Bodies is not encouraging. However, the Commission has indicated that new accreditation announcements are under way.
• Postponement of the “go-live” date of the European database on medical devices (Eudamed) appears inevitable. However, many of the implications of this delay are still unclear and guidance from the Commission and Member States is necessary.

Draft Corrigendum No. 2
It has long been known that the Commission has been working on a second corrigendum to the MDR that would, inter alia, incorporate a grace period for Class I medical devices that would be moved into a higher-risk class under the MDR and therefore require the involvement of a Notified Body.

An important step towards providing such relief to the medtech industry was taken this week when the draft Corrigendum No. 2 was published by the Council of the European Union. Products that would benefit from the proposed grace period are, in particular, certain software that qualifies as medical devices (see Sidley Update on the classification of software under the MDR here), as well as certain reusable products such as surgical instruments and endoscopes. These are generally moved to higher-risk classes under the MDR.

The draft Corrigendum No. 2 proposes to amend the MDR’s transitional provisions by granting a four-year transitional period to medical devices that are now classified as Class I but would be moved to a higher-risk class under the MDR. Currently, such medical devices must comply with all of the MDR’s requirements related to their new risk class from May 26, 2020, including the involvement of a Notified Body for the conformity assessment procedure. To benefit from the proposed transitional provision, medical devices must continue to comply with applicable Medical Devices Directive requirements after May 26, 2020, and there must be no significant changes in the design or intended purpose of the medical devices.

The draft Corrigendum No. 2 has now been transmitted to the European Parliament for the next phase of the adoption process. It is expected that a final Corrigendum No. 2 will be adopted and published by the end of this year, or in the beginning of 2020.

Regardless of the transitional periods granted, the MDR will become applicable soon, and certain MDR requirements related to, for example, postmarket surveillance, market surveillance and vigilance will apply to all classes of medical devices starting May 26, 2020.

Availability of Notified Bodies
Currently, only a limited number of Notified Bodies have received accreditation under the MDR and In Vitro Diagnostic Regulation (IVDR). The New Approach Notified and Designated Organisations Information System (NANDO) shows that seven Notified Bodies have been designated under the MDR (list available here) and two under the IVDR.

A number of joint assessments by Member States and the Commission have taken place in recent months, and it is expected that a small wave of new designations will be published soon (e.g., accreditation of at least one additional Notified Body should be published shortly). Currently, it is expected that there will be approximately 20 Notified Bodies accredited under the MDR by May 2020.

Guidelines and Pipeline
In addition to these developments, the Commission’s Medical Devices Coordination Group (MDCG) continues to work on various guidelines aiding the proper implementation of the MDR and the IVDR. A large number of guidelines have already been issued, and the MDCG maintains an overview of guidelines in the pipeline.

Eudamed Delay
As extensively reported by various sources, Eudamed’s “go-live” date has been postponed for two years. The MDR has a built-in provision that addresses such delay by deferring the application of certain provisions directly affected by Eudamed, for example, the electronic registration of economic operators and uploading of periodic safety update reports (PSURs). However, it remains unclear how the many MDR requirements implicitly linked to Eudamed will be affected and enforced; for example, must manufacturers manually send PSURs to the Member States?

The delay of Eudamed and its ramifications for the MDR’s application will be discussed by the Commission and the Member States’ competent authorities during a meeting in mid-December.

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Companies placing or intending to place medical devices on the EU market after May 25, 2020, should consider how the MDR, its transitional rules and the various guidelines may affect their operations and whether any changes may be necessary. The new rules are generally expected to represent significant additional work for medical devices manufacturers to ensure a smooth transition and avoid supply interruptions.