Regulation of medical devices in times of COVID-19
How will COVID-19 affect medical devices regulation in Europe? And will the MDR be further postponed?
An analysis by our MDR-expert Jan Brönneke.
Earlier this week we published a blogpost on the impact of digital health on the current COVID-19-pandemic taking a glance at the status quo and potential of digital technologies that can be helpful under the given circumstances. Many good products have been developed rapidly during the last weeks, many of them now facing regulatory requirements regarding – among other fields – the authorisation of these products.
Healthcare-systems are highly regulated markets with regulations mainly aiming at improving and ensuring patient safety. These rules cannot be suspended, even under the circumstances of a substantial crisis as the current one as new technologies still have to prove that they help patients rather than harming them. However, legislators and regulators on all levels are currently working on minimising administrative hurdles for developers of new solutions potentially helping to fight COVID-19.
Two Initiatives by the European Commission (EC) are of special importance in this regard:
On March 13. the Commission published Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat. Although a non-binding act of the Commission, the Recommendation can have a big impact on administrative practice of the member states and the respective authorities. The said recommendation refers to authorisation of personal protective equipment (PPE) as well as medical devices. Regarding the latter the commission recommends to make use of the exemption clause of Art. 11 para. 13 Medical Device Directive (MDD) or – as soon as applicable – Art. 59 Medical Device Regulation (MDR), also for low risk products (class I). The provision allows the competent authorities to authorise specific products that for which a conformity assessment has not been completed but which are in the interest of public health or patient safety or health. Furthermore, the Commission recommends that the relevant market surveillance authorities should focus on such devices that are raising serious risks for health and safety and at the same time should directly assess and (temporarily) authorise devices that are currently in the authorisation procedure or even on the market without bearing the CE marking. Devices that are authorised without bearing the CE marking are only allowed to be distributed to healthcare workers and only for the duration of the crisis, a distribution through regular channels and to other users has to be excluded. This recommendation, if followed by the member states and the respective authorities, can have a huge impact on the current situation as it disburdens the notified bodies that are normally responsible for the conformity assessments of all medical devices class IIa or higher.
The second initiative of the European Commission has an even bigger scope and – if followed by Parliament and Council – will have a huge impact on the current situation: According to a statement of the Commissions Directorate General for Health and Food Safety (DG SANTE) on March 25. the Commission currently works on a proposal to postpone the MDR’s application date by one year. The highly disputed MDR is to be applied as of May 26. 2020. One of the most criticised aspect of the regulation is the rigorous notification process for Notified Bodies and the consequential decrease in the number of these Bodies. Europewide only 12 Notified Bodies are currently listed to conduct conformity assessment in accordance with MDR (compared to nearly 50 Notified Bodies under the MDD-regime) – a fact that is certainly posing a bottleneck to authorisation procedures for medical devices class IIa or higher. Together with the still existing uncertainties about specific requirements and procedures of the MDR, the application of it in May would make market access unnecessarily hard for a probably high number of devices. Although the general restructuring of European medical device law is necessary and reasonable, the current situation is not the right one to effectively implement the new rules.