New start of application of MDR on 26.05.2021

New date of application of the MDR (Regulation (EU) 2017/745) on 26.05.2021 – Amendment Regulation (EU) 2020/561 came into force

On 24.04.2020 the “REGULATION (EU) 2020/561 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 April 2020 amending Regulation (EU) 2017/745 concerning medical devices as regards the date of application of some of its provisions” was published in the Official Journal of the EU and entered into force on the day of its publication.

In the wake of the COVID-19 pandemic, the legislative procedure to postpone MDR has been carried out extremely quick and silent. The Commission had only published its proposal for a moratorium on MDR on 03.04.2020.

For economic actors, the (amendment) Regulation (EU) 2020/561 essentially means:

  • The general date of application of MDR is postponed by one year. The MDR will therefore only apply from 26.05.2021 (Art. 123 para. 2 MDR new).
  • In contrast, the possibility of special approvals (exemptions from the conformity assessment procedures) according to Art. 59 MDR at Union level will already exist from 24.04.2020. This is intended to enable the extension of national special approvals to the entire Union in the short term in order to combat the COVID-19 crisis and to quickly counter bottlenecks in important medical equipment.
  • On the other hand, other transitional arrangements important for economic actors in the medium term will not be postponed: The so-called “Grace Period” for old certificates and for higher-classified Class I products ends, as before, on 26.05.2024 (Art. 120 para. 3 MDR new) and the sales period for old products ends, as before, on 26.05.2025 (Art. 120 para. 4 MDR new). Manufacturers, importers and distributors must take these formally shortened transition periods into account in their product planning.

At Member State level, the postponement of the MDR requires corresponding adjustments to national implementing legislation. In Germany, the legislation amending the already adopted Medical Device Law Implementing Act (MPDG) can now be expected very soon. As a result, the previous directive law and the Medical Devices Act (MPG) will also go into the one-year extra time.

Link to the English version: Regulation (EU) 2020/561

Do you have any questions about this news or would you like to discuss the news with the author? You are welcome to contact: Dr. Boris Handorn

24. April 2020 Prof. Dr. Boris Handorn