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The entry into application of Regulation (EU) 2017/745 of April 5th, 2017 relating to medical devices (MDR) is postponed by one year

25 April 2020 Marie SANCHEZ

The EU authorities have decided to postpone the entry into application of the MDR, initially scheduled on May 26th, 2020, to May 26th, 2021. The authorities explain this decision by the critical need to avoid any shortages in stock of vital medical devices (MD) during the COVID-19 pandemic. It is also a way to ensure that the parties concerned will be able to implement and make a correct application of the MDR, which would have been impossible on May 26th, 2020, due to the extraordinary difficulties generated by the sanitary crisis and the complexity of MDR itself. 

Regulation (EU) 2020/561 of April 23rd, 2020, published in the OJEU of April 24th, 2020, therefore provides the following modifications to the MDR:

– The application of certain provisions of the MDR is postponed as follows:

• The adoption of the common specifications is postponed to May 26th, 2021;
• Single-use MDs which were placed on the market before May 26th, 2021 in accordance with Directive 93/42/EEC can be reprocessed;
• Reusable MD that must bear the UDI carrier on the MD itself can remain on the market, provided that UDI carrier is placed on the label and on all higher levels of packaging, according to the following schedule:

• implantable MD and class III MD: from May 26th, 2023 onwards;
• class IIa and IIb MD: from May 26th, 2025 onwards;
• Class I MD: from May 26th, 2027 onwards.

• The deadline for the operational functioning of EUDAMED is extended to March 25th, 2021;
• Member States shall notify to the Commission the rules on penalties for infringement of the provisions of the MDR no later than February 25th, 2021.

– Adaptation of the transitional provisions:

• As from May 26th, 2021, any publication of a notification relating to a notified body in accordance with the directives is invalidated;
• Class I MDs for which the declaration of conformity was drawn up before May 26th, 2021 and for which the conformity assessment procedure under the MDR requires the intervention of a notified body, or who have a certificate issued under the directives which is still valid, may be placed on the market or put into service until May 26th, 2024, provided that from May 26th, 2021 onwards, they continue to comply with the directives and there is no significant change in design and destination of the MD;
• MDs legally placed on the market in accordance with the directives before May 26th, 2021 may continue to be made available on the market or put into service until May 26th, 2025;
• MDR-compliant MDs can be placed on the market before May 26th, 2021;
• Conformity assessment bodies conforming to the MDR can be designated and notified before May 26th, 2021 and thus implement the conformity assessment procedures established by the MDR and issue certificates in accordance with the MDR before May 26th, 2021;
• MDs manufactured using tissues or cells of animal origin, or their derivatives, which are non-viable or made non-viable and which have been legally placed on the market or put into service in accordance with the rules in force in the Member States before May 26th, 2021 may continue to be placed on the market and put into service in the Member States concerned;
• Clinical investigations carried out in accordance with the directives and which started before May 26th, 2021 may continue to be conducted. However, as of May 26th, 2021, notification of serious adverse events and device failures will be made in accordance with the MDR.

– Setting up of a derogation:

• During the period from April 24th, 2020 to May 25th, 2021, any competent authority, upon duly justified request, may authorize the placing on the market or the entry into service, in the territory of the Member State concerned, of a specific MD that has not been evaluated in accordance with the applicable procedures, but the use of which is in the interest of public health or the safety or health of patients;
• The derogatory authorizations granted on the basis of Directives 90/385/EEC and 93/42/EEC before April 24th, 2020 are maintained;
• The European Commission may decide to extend the derogatory authorization obtained to the territory of the EU, for a limited period of time and on conditions it defines, in case of exceptional reasons related to public health or to safety or health patients.