The EU proposes to allow low-risk Class I devices four more years to comply with the EU Medical Device Regulation.
The Council of the European Union’s latest set of corrections for the EU MDR would extending the compliance date for low-risk Class I devices to May 26, 2024.
The proposed revision would clarify that Class I devices that need a conformity assessment for CE marking and had a conformity assessment conducted before May 26, 2020 could be placed in the market until May 26, 2024.
The proposed change applies to devices that may have been up-classified as a result of the MDR.
The addition to the regulation states that: “By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues…”
The European Commission released a previous MDR update in March, providing guidance on the Eudamed inspection database and the device nomenclature system that will be used for the EU MDR and EU IVDR. The new regulations go into effect on May 26, 2020 for devices and on May 26, 2022 for IVDs (IDDM, March 29).