2023, March 19 – Boumans Regulatory Consulting

MDR Article 120 and 122 consolidated

2023, April 272023, March 19 by Ronald Boumans

Note: new text is in bold Article 120 Transitional provisions Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the … Read more

MDR Amendment Regulation (EU) 2023/607

2023, March 202023, March 19 by Ronald Boumans

how this may (not) work for you Elevator pitch The new amendment to the MDR is nicknamed the ‘MDR Extension Regulation’. This has some truth in it, but it does not cover the whole story. It may also create incorrect expectations with stakeholders. So here is the one-sentence elevator pitch I would recommend preparing, in … Read more