Based on the increased burdens on the medical devices industry and the European Union (EU) Member States caused by the COVID-19 crisis, the European Commission (Commission) has taken the drastic step of proposing to delay the application of the Medical Devices Regulation (MDR) by one year. The MDR was supposed to repeal and replace the EU Medical Devices Directive (MDD) and the EU Active Implantable Medical Devices Directive (AIMDD) on May 26, 2020.
Today, the Commission therefore published its eagerly awaited proposal to amend the MDR as regards the dates of application of certain of its provisions (Proposal). The Proposal defers the application of most provisions of the MDR until May 26, 2021.
Additional Time to Implement MDR
The Proposal, if adopted, would give the medical devices industry one additional year to ensure compliance with the MDR requirements. Industry would also have one more year to obtain MDD certificates from their Notified Bodies, ensuring that these would be covered by the transitional provisions of the MDR.
Member State Derogations Applicable at EU Level
The Proposal also amends Article 59, which is a novel provision in the MDR. It allows individual Member States to authorize medical devices without a CE mark in their respective territories if there is a public health or patient safety or health interest. The Commission can in “exceptional circumstances,” and for a limited period of time, extend the EU Member States’ decision to the entire EU market. If adopted, the Proposal would make this emergency procedure applicable also to decisions taken under Article 11(13) of the MDD, which similarly allows the EU Member States to authorize medical devices without a CE mark to be placed in their respective territories. However, unlike the MDR, the MDD does not permit the Commission to extend the validity of an authorization granted by an EU Member State to the rest of the Union. If adopted, the revised Article 59 would also apply to decisions by the Member States under Article 11(13) of the MDD adopted prior to the Proposal’s adoption.
This new mechanism, whereby the Commission may extend individual Member States’ decision to permit a non-CE marked device to the rest of the EU, would have a major impact on many manufacturers who, in response to the COVID-19 pandemic, are currently seeking derogations for their products at individual EU Member State level.
In this respect, several EU Member States have already adopted national exemptions from CE-mark requirements due to COVID-19, following the publication of the Commission’s Recommendation of March 13, 2020. National competent authorities that have already adopted national exemptions due to COVID-19 (or released guidance) include:
- Belgian Federal Agency for Medicines and Health Products (guidelines are available in French and Dutch only)
- Dutch Health and Youth Care Inspectorate (available in Dutch only)
- Irish Health Products Regulatory Authority
- Italy (legislative decree) and its National Health Institute (guidelines, both available in Italian only)
- UK Medicines and Healthcare products Regulatory Agency (MHRA) (Click here to view our Sidley Update on, inter alia, the MHRA’s COVID-19 measures for medical devices)
To date, the Commission has not published a proposal to defer the application of certain provisions of the EU In Vitro Diagnostics Medical Devices Regulation, including its Article 54 which is similar to Article 59 of the MDR.
The Proposal is now subject to an accelerated procedure and must be adopted by the Parliament and the Council before entering into force.
OVERVIEW OF PROPOSED CHANGES TO ARTICLE 59
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