Do the math: Regulation 2023/607 The MDR was created under the assumption that manufacturers would be able to switch from the AIMDD and MDD to the MDR during their normal certification cycle. However, it took years before the first notified body was designated and the designation process is still ongoing, supporting structures, like EUDAMED, expert … Read more
This section is about: Regulation (EU) 2023/607 Regulation (EU) 2023/607 on MDR transitional arrangements allows for manufacturers of devices that were certified under the ‘old’ Directives to remain certified as such for some years to come, while they wait until they become certified under the MDR. In general, this will require the manufacturer to prepare … Read more
This section is about: Regulation (EU) 2023/607 Regulation (EU) 2023/607 on MDR transitional arrangements allows for manufacturers of devices that were certified under the ‘old’ Directives to remain certified as such for some years to come, while they wait until they become certified under the MDR. In general, this will require the manufacturer to prepare … Read more
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
PRRC scenario, as posted on LinkedIn on 8 February 2023 According to MDCG Guidance 2021-25 on legacy medical devices, the PRRC is not required for legacy devices. With that in mind, a freshly appointed PRRC had a fairly easy job; the company was not MDR certified yet. With the current proposal of the European Commission … Read more
Helping your notified body working efficiently We all know that notified bodies are in short supply and they should work as efficient as possible. There is something we can all do to help: prepare documentation well. It sounds obvious, but I still have to explain to companies that notified body reviewers want to see clear, … Read more
Article 16 inconsistencies As you can read in another tip of the week, MDR Article 16 allows for a third party to repackage or relabel a device or to translate the instructions for use and add them to a device already placed on the market. Packaging, labelling and providing user information are typical manufacturer’s responsibilities … Read more
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