Effective today, August 6, 2024, the ‘’Actors’’ module of the Swissdamed medical devices database is…
MDR and IVDR changes officially published
Today, 9 July 2024, Regulation (EU) 2024/1860 was listed in the Official Journal of the…
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…
Regulatory updates: January 2024
With the start of 2024, the EU, UK, and Swiss competent authorities provided new regulatory…
Business associations’ letter on EUDAMED mandatory use
Six industry associations on medical devices and healthcare have jointly signed an open letter on…
EUDAMED delay announced!
The European Commission has officially announced a delay in the full implementation of the EUDAMED…
MDR National implementation: Latvia
Latvia has implemented the Medical Devices Regulation 2017/745 (MDR) through its Medical Device Rule No 461 and…
Update on EUDAMED state of play
The European Commission has released new minutes of the MDCG EUDAMED working group meeting of…
Swissdamed: roll-out plan of the Swiss database on medical devices
Like the European Union, also Switzerland implemented the obligation to register medical devices and IVD…