Effectiveness of MDR postponed for one year

30. 9. 2022 | Articles, Medical devices

On 24.4.2020, Regulation (EU) 2020/561 of the European Parliament and of the Council of 23.4.2020 was published in the Official Journal, which postponed the entry into force of the MDR (Medical Devices Regulation (EU) 745/2020 for one year to 26.5.2021. In practice, this means that medical devices can be placed on the market until 25.5.2021 in accordance with the existing legislation, specifically in the case of the Czech Republic in accordance with Act No. 268/2014 Coll, 22/1997 Coll., on technical requirements for products, as amended, and Government Regulation No. 54/2015 Coll., on technical requirements for medical devices.

The full text of Regulation (EU) 2020/561 can be found here: https://eur-lex.europa.eu/legal-content/CS/TXT/PDF/?uri=CELEX:32020R0561&from=EN