Today, 9 July 2024, Regulation (EU) 2024/1860 was listed in the Official Journal of the…
Challenges for combined studies of medicines, IVDs, and devices
In the European Union, there are different regulatory requirements for clinical trials of medicinal products,…
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…
MDR & IVDR national requirements: France
France has incorporated the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Devices…
2024: Which MDCG guidance can we expect?
The European Commission has released the updated document on the ongoing work of the MDCG…
Notified Bodies survey on MDR/IVDR certifications and applications – March update
The European Commission has released updated data from the survey conducted among Notified Bodies on…
Team-NB issues recommendations on the classification of SARS-CoV-2 IVDs
Team-NB, the European Association of Medical Devices Notified Bodies, has released a position paper providing recommendations for…
Council adopts IVDR legacy extension and sooner mandatory use of EUDAMED
On 14 February 2024, the Council of the European Union endorsed the European Commission’s proposal…
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…