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…
MDR: 43rd Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! CESKY METROLOGICKY INSTITUT a.…
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 MDCG Guidance documents on Annex XVI products
In December 2023, the Medical Device Coordination Group (MDCG) published for the first time two…
Updated MDCG Guidance on clinical investigation
A clinical investigation can demonstrate a medical device’s safety and clinical performance. In December 2023,…