The Medical Device Coordination Group (MDCG) just published the second guidance of the year. MDCG…
EC Proposal to extend IVD legacy period and make EUDAMED mandatory sooner
On 23 January 2024, the European Commission published a Proposal to extend the IVDs legacy…
National language requirements in the EU for MDR & IVDR devices
The European Commission has released a table on the existing language requirements for manufacturers under…
IVDR Joint Implementation Plan has been published!
The Medical Devices Coordination Group (MDCG) has issued a joint implementation and preparedness plan for…
Regulatory updates: January 2024
With the start of 2024, the EU, UK, and Swiss competent authorities provided new regulatory…
MDR & IVDR national implementing law: Iceland
The implementation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation…
Business associations’ letter on EUDAMED mandatory use
Six industry associations on medical devices and healthcare have jointly signed an open letter on…
MedTech Europe’s recommendations on May 2025 deadline for Class D IVDs
MedTech Europe published a new position paper ahead of May 2025 deadline for Class D…
New Team-NB position paper on medical device lifetime
Team-NB has released a document to clarify the concept of “medical device lifetime”. The Medical…
First EU Reference Laboratories designated under the IVDR!
The European Union designated on 5 December 2023 its first EU reference laboratories (EURL) for…