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,…
MDR: 48th Notified Body on NANDO!
The NANDO database lists a new Notified Body under the MDR, which is the second NB in 2 days! Kiwa Belgelendirme Hizmetleri A.Ş. is overall…
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…
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 certifications and applications under the Medical Devices Regulation (MDR) and…
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 for a gradual roll-out of EUDAMED as well as for…
Notified Bodies Survey on MDR and IVDR certifications
In February 2024, the European Commission published the results of the sixth survey conducted until October 2023 on MDR and IVDR certifications and applications. As…
IVDR Joint Implementation Plan has been published!
The Medical Devices Coordination Group (MDCG) has issued a joint implementation and preparedness plan for the In Vitro Diagnostic Medical Devices Regulation (IVDR). This plan…
EU and Italian authorities urge manufacturers to transition to MDR/IVDR in time
The Medical Device Coordination Group (MDCG) has issued a new revision of its notice to manufacturers and notified bodies to ensure they timely comply with MDR and…
Notified Bodies survey on MDR/IVDR certifications and applications
The European Commission has released updated data from the survey conducted among Notified Bodies on certifications and applications under the Medical Devices Regulation (MDR) and…