article 97 – Boumans Regulatory Consulting

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

Feasibility check for the applicability of MDR Article 97

2023, January 72023, January 4 by Ronald Boumans

Expiring certificate At this moment AIMDD or MDD certificates may expire before a new MDR certificate is issued. In that case, a manufacturer may lose access to the EU market. MDCG 2022-18 provides guidance about how the Competent Authorities will handle the specific situation when a non-conformity is created by the expiration of a certificate … Read more