The European Commission has released new minutes of the MDCG EUDAMED working group meeting of…
Poland: MDR & IVDR national implementing laws
Upon the publication of the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic…
New flowchart on the scope of MDR legacy period extension
On 23 August 2023, the European Commission has released a new flowchart to assist manufacturers…
Swissdamed: roll-out plan of the Swiss database on medical devices
Like the European Union, also Switzerland implemented the obligation to register medical devices and IVD…
NB Position Paper on the new MDR transition timelines
On 10 August 2023, Team-NB, the European Association of Medical Devices Notified Bodes, published a…
Legacy device manufacturers: Important deadlines & steps
Legacy devices are devices that are typically covered by a valid CE Certificate or are…
United Kingdom: CE marking recognition for medical devices and IVDs
Following the government’s decision to extend the CE mark recognition for a wide range of…
MDR national implementation: Spain
The Spanish Agency on medical devices (AEMPS) published on March 21, 2023, its national law implementing the…
Updated Notified Bodies survey on MDR/IVDR certifications and applications
The European Commission has issued an updated document on their survey conducted among Notified Bodies on…
European Commission updates factsheet for non-EU/EEA authorities
The European Commission has published an updated factsheet for authorities in non-EU/EEA states on medical…