Health care update: MDR moratorium, national legislation, COVID-19
The coronavirus pandemic and awareness of the resulting burden on all economic operators in the health care sector have recently accomplished something which seemed unthinkable at the beginning of the year: European lawmakers have been prevailed upon to postpone the effective date of the MDR by one year, to 26 May 2021.
For many economic operators, this postponement was an urgently necessary step which allows them to continue placing medical devices on the market for another twelve months in accordance with the familiar EU Directives. But at the same time, postponing the effective date does not eliminate all obstacles on the path towards compliance with the MDR. For example, the transitional period in accordance with Article 120 of the MDR for the toleration of medical devices which were placed on the market in conformance with the applicable Directives will be shortened from four to three years. The original expiration date for this transitional period (26 May 2024) is unchanged by the moratorium.
Another problem at the moment is support for manufacturers by notified bodies in assessing the conformity of new medical devices: on-site audits are still impossible for many manufacturers due to social distancing rules. At the same time, the "Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19," dated 8 April 2020, makes no provision for remote audits, whether for initial certification audits or for audits to extend the scope of certification. The longer on-site audits are postponed as a result of the lockdown, the shorter the transitional period will be.
These problems are exacerbated by the number of notified bodies which are accredited under the MDR's rules, which continues to be limited. The EU Commission has clearly fallen short of its stated goal of accrediting 20 notified bodies by the end of 2019. As things stand today (8 June 2020), only 14 bodies have been accredited according to the Nando database.
It is also to be expected that the Eudamed database, a key element of the MDR, will not be usable until 26 May 2022 at the earliest.
There continues to be a need for legislation and guidelines to create more legal certainty for operators in the industry. Although the decision to postpone the MDR's effective date has been welcomed by industry representatives and economic operators in the industry, it is also clear that, in no small number of cases, the pandemic is forcing the "postponement" of firmly scheduled certification dates and milestones for the marketing of new medical devices.
This means that is all the more important for manufacturers to stay on course and maintain their focus to ensure that their companies and products are in compliance with the MDR. They should take advantage of the time they "gain" to close any remaining gaps between the current status in accordance with the MDD and the future status under the MDR.