2020 has finally arrived, the year long marked in our calendars as signalling the implementation of the Medical Devices Regulation (MDR). The MDR comes into force on 26 May 2020, replacing the outgoing Medical Devices Directive (MDD) and changing the face of the medical devices regulatory regime. The question arises: are we ready for the new regime? On 8 January, with the champagne still bubbling, the industry representative body Medtech Europe published a report on the ‘Implementation Status of the Medical Devices Regulation’, aptly captioned ‘A Call to Action’ (here), making a strong case that much remains to be done to ensure a smooth transition and we are running dangerously short on time.
The Report outlines the three ways in which medical devices can be placed on the market after 26 May 2020, and notes the currently unresolved difficulties with each of them.
The options available to medical device manufacturers are:
- obtaining CE certification against the new MDR requirements by 26 May 2020;
- obtaining CE certification against the current MDD requirements by 26 May 2020 and make use of the transitional “grace period” (for eligible devices); and
- applying for a time-limited derogation at national level in respect of MDD devices that fail to satisfy the grace period requirements, and requesting that the European Commission renders the derogation EU-wide to keep such devices available.
Among other shortcomings, the Report stresses the lack of Notified Body capacity to cope with requests under the first and second pathways. MDR-designation of Notified Bodies has proved a very slow process: only 9 (out of 55) notified bodies have been approved to certify devices against the MDR. Those few Notified Bodies are significantly overworked. Exacerbating the issue, we still await expert panels, Implementing Acts and EU Guidance in various areas. The Report calls on EU institutions to accelerate implementation and MDR-designation of Notified Bodies.
According to Medtech Europe, even the MDD-designated Notified Bodies, which could assist applicants following the second pathway, are under pressure due to their high workload. The Report further highlights the uncertainty around the grace period and in particular the prohibition on “significant changes to their design or intended purpose” after 26 May 2020. The Report calls for clarity on the interpretation of what constitutes a “significant change” in this context.
Regarding the third “pathway”, the Report notes that the newly introduced EU-wide derogations was clearly not designed to cope with this particular “bottleneck” scenario, but argues for it to be made into a systemic solution to ensure supply as a matter of last resort should it prove impossible to implement the first two options in time.