The Medical Device Coordination Group (MDCG) just published the second guidance of the year. MDCG…
MDCG Guidances on vigilance system for CE-marked devices
The Medical Devices Coordination Group (MDCG) has released a new set of guidances on the…
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…
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…
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…