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)…
MDR: 49th Notified Body on NANDO!
The NANDO database now includes the first Austrian MDR Notified Body, which brings the total…
MDR: 48th Notified Body on NANDO!
The NANDO database lists a new Notified Body under the MDR, which is the second…
MDR: 47th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! MTIC InterCert S.r.l. is…
MDR national implementation law: Portugal
On April 5, 2024, the Portuguese Decree-Law no. 29/2024 was officially published to enforce Regulation…
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: 46th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! AFNOR Certification is the…
New MDCG Guidance on content of the Investigator’s Brochure for clinical investigations under MDR
Recently the MDCG (Medical Device Coordination Group) published a guidance on the content of the…