On 14 August 2024, the Swiss Federal Department of Home Affairs (FDHA) announced Switzerland’s alignment…
MDCG on appropriate surveillance for legacy devices
On 27 May 2024, the MDCG (Medical Device Coordination Group) published an updated version of…
Parliament votes in favor of IVDR legacy extension and EUDAMED mandatory use
On 25 April 2024, the European Parliament voted in favour of the Proposal to extend…
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…
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…
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…
Updated MDCG Guidance on significant changes (MDR transitional provision)
On 12 May 2023, the Medical Device Coordination Group (MDCG) published the revised Guidance on…
Feedback on amendment of common specifications for products without intended medical purpose
Between 8 May and 5 June 2023, medical device stakeholders can submit feedback on the…
Team-NB: Notified Body Confirmation Letter to prove application and signed agreement
The latest developments in the implementation of the medical devices and IVD medical devices Regulations…
Q&A on extension of the MDR transitional period and removal of the “sell off” period
Following the publication of the latest amendment to the Medical Devices Regulations (MDR and IVDR),…