Deadline extension for medical devices (cepAdhoc)


In order to avoid impending shortages of medical devices as of May 2020 and with the aim to guarantee patient safety, the Council proposed an extension to the deadline for certain medical devices on 25 November 2019. The cep has assessed this in an Adhoc.


According to cep, the proposed new transitional provision is the wrong approach to the right objective: The proposal is necessary to "correct" the Medical Devices Regulation but using a "corrigendum" is procedurally questionable since the intention is to change the meaning of the Regulation substantially. A repeal by the European Court of Justice would have negative consequences. It is therefore necessary to amend the Regulation in accordance with the ordinary legislative procedure which is easily possible within the time remaining.