On 25 April 2024, the European Parliament voted in favour of the Proposal to extend…
New MDCG guidance on safety reporting in IVDs performance study
The MDCG (Medical Device Coordination Group) just published a new guidance document on safety reporting…
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…
EU and Switzerland start negotiations to deepen bilateral relations
The European Commission and the Swiss Confederation announced on 18 March the start of negotiations…
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…
Parliament approved the Artificial Intelligence Act
Today, 13 March 2024, the European Parliament approved the text of the Artificial Intelligence Act.…
MHRA on future UK law on medical devices
On 5 March 2024, the UK MHRA (Medicines and Healthcare Products Regulatory Agency) held the…
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…