MDCG 2022-18 : MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate – December 2022

This position paper concerns legacy medical devices, i.e. devices with an MDD or AIMDD certificate that have continued to be marketed after the date of entry into force of the MDR (Article 120 of the MDR). This new MDCG document discusses the implementation of Article 97 of the MDR for legacy devices whose MDD or AIMDD certificate expires before the transition to RDM certification is concluded in time. An annex is available at the end of the document and consists of a checklist the documents that the manufacturer or his authorized representative should send to his competent authority to benefit from the provisions of Article 97 of the MDR.