The Medicines and Health Regulatory Authority (MHRA) has announced on May 21, 2024, the intention…
Challenges for combined studies of medicines, IVDs, and devices
In the European Union, there are different regulatory requirements for clinical trials of medicinal products,…
New REACH restrictions on D4, D5, and D6 apply to medical devices and IVDs
On 17 May 2024, the Official Journal of the European Union published Commission Regulation (EU)…
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…
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.…