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
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
Pharmaceutical companies that want to place a non-integral drug-device combination on the EU market need to work together with a medical device manufacturer. The device must be CE-certified for the right intended purpose before the market authorization application can be filed. Therefore, it is important for the drug company to keep sufficient control over the … Read more
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
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
UKCA-marking and devices Medical devices and IVD’s (devices) that are placed on the UK market can still be CE-marked, but the UKCA-marking is also possible. For these devices the UK Medical Devices Regulations 2002 apply, which is basically the UK version of the ‘old’ combined directives (AIMDD, MDD and IVDD). Although the Regulations 2002 have … Read more
Boumans Regulatory Consulting BV
