article 59 – 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

Article 54/59 derogation – yes, it can be done, but I rather suggest you should try not having to depend on it…

2022, September 18 by Ronald Boumans

Article 59 MDR/Article 54 IVDR Article 59 (1) says: ‘By way of derogation from Article 52 of this Regulation (…), any competent authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the applicable … Read more