The MDR and COVID-19 – Moratorium of the MDR decided!

The pandemic of the Corona virus affects all of us and especially medical devices are currently the most important aid for patients.

To prevent shortages of medical devices for the treatment of patients, e.g. due to expiring CE certificates of medical devices, provided after the old directive for medical devices (MDD), the BVMed endorses a moratorium of the new regulation for medical devices (MDR) until the Corona crisis is under control. In addition to the already known complications (like the low number of notified bodies and missing guidelines), notified bodies and authorities are also directly affected by the Corona pandemic [1].

The BVMed suggests:

protection for “old” medical devices, which applied for a new certificate at an MDR-approved notified body until the 26.05.2020, but are not under investigation due to reduced capacities of the notified body,

national “special approval” according to article 59 of the MDR, for all medical devices with existing CE-marks according to the MDD.

The European representative Peter Liese argues in a similar direction and demands: “It is important, that medical devices, e.g. ventilators work properly, but some actions according to the new medical device regulation are anyway over-bureaucratic. Therefor, we need a flexible implementation now” [2].
Postponing of the MDR is also favoured by the German industrial association SPECTARIS. Represented companies, e.g. a global market leader for ventilators, expressed problems of the implementation of the new MDR already prior to the Corona crisis, which are now drastically enhanced due to the current situation [3].

The European confederation of pharmaceutical entrepreneurs (EUCOPE) sent a letter to the European commission, demanding postponing of the MDR to a timepoint 6 months after declining of the Corona outbreak. Herein, the confederation emphasizes the central function of medical devices for a solid and safe healthcare system.

According to information provided by “Tagesspiegel Background”, postponing of the entering into force of the MDR seems probable: The European commission currently examines that, a speaker said. To minimize potential shortages for the member states during the fight against the Corona virus has the highest priority. It is of outermost importance to prevent interruption of the medical devices supply for the stressed healthcare systems [4].

The European commission announced in a press conference, that they work on a proposal to postpone the MDR for one year. The proposal should be available for the parliament and the European council in early April [5]. On April 3rd, a corresponding proposal was published.

On April 17th, a postponement of the MDR until May 26th, 2021 was decided by the European Parliament. However, only the date of application but not the transition period is postponed, which is thereby shortened to three years, ending on May 26th, 2024 [6].
Nonetheless, the deadline to achieve conformity of medical devices with the MDR is only delayed! Therefor, it is still recommended to aim for MDR conformity.

In case there are questions regarding the MDR, or support is needed on the way to the CE mark for your medical device (e.g. preparation of a technical documentation in conformity to MDR), we will gladly consult and support you. Please contact the team of YES Medical Device Services!

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