The Medical Device Coordination Group (MDCG) just published the second guidance of the year. MDCG 2024-02, on the procedures for the updates of the European…
MDCG Guidances on vigilance system for CE-marked devices
The Medical Devices Coordination Group (MDCG) has released a new set of guidances on the vigilance systems for CE-marked devices. As such, a template is…
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 period and make EUDAMED mandatory earlier than planned. With this…
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 MDR and IVDR, compiling all national language requirements required for…
Regulatory updates: January 2024
With the start of 2024, the EU, UK, and Swiss competent authorities provided new regulatory documents. In this post, we will provide an overview of…
MDR: 43rd Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! CESKY METROLOGICKY INSTITUT a. s. is the 43rd EU Notified Body notified under the…
Business associations’ letter on EUDAMED mandatory use
Six industry associations on medical devices and healthcare have jointly signed an open letter on the mandatory use of EUDAMED. The six associations call for…
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 Devices Regulation (MDR) does not specifically provide a definition for…
First MDCG Guidance documents on Annex XVI products
In December 2023, the Medical Device Coordination Group (MDCG) published for the first time two guidance documents on Annex XVI devices. Annex XVI products are…
Updated MDCG Guidance on clinical investigation
A clinical investigation can demonstrate a medical device’s safety and clinical performance. In December 2023, the Medical Device Coordination Group updated the guidance on clinical…