On 12 March 2025, Team-NB released a statement on certificates with conditions. The EU Medical Device Regulation (MDR) 2017/745 and the In-Vitro Diagnostic Regulation (IVDR)…
Transitional provisions for Class D IVDs: Updates to MDCG 2021-4
In September 2024, the MDCG published a revised version of MDCG 2021-4. This guidance addresses the application of transitional provisions for certification of class D…
Important deadline for legacy manufacturers: 26 September 2024
By 26 September 2024, manufacturers of legacy devices must have signed a written agreement with a notified body for MDR CE certification. Before this deadline,…
MDCG on appropriate surveillance for legacy devices
On 27 May 2024, the MDCG (Medical Device Coordination Group) published an updated version of MDCG 2022-4. This document is a guidance on appropriate surveillance…
MDR: 47th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! MTIC InterCert S.r.l. is the 47th EU Notified Body notified under Regulation (EU) 2017/745…
MDR: 46th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! AFNOR Certification is the 46th EU Notified Body notified under Regulation (EU) 2017/745 on…
MDR: 45th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! TÜV SÜD Danmark is the 45th EU Notified Body notified under Regulation (EU) 2017/745…
MDR: 44th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! RISE Medical Notified Body AB is the 44th EU Notified Body notified under the…
MDR: 43rd Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! CESKY METROLOGICKY INSTITUT a. s. is the 43rd EU Notified Body notified under the…
MDR: 42nd Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! Scarlet NB B.V. is the 42nd EU Notified Body notified under the Regulation (EU)…