By 26 September 2024, manufacturers of legacy devices must have signed a written agreement with…
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: 46th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! AFNOR Certification is the…
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…
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…
Notified Bodies Survey on MDR and IVDR certifications
In February 2024, the European Commission published the results of the sixth survey conducted until…
IVDR Joint Implementation Plan has been published!
The Medical Devices Coordination Group (MDCG) has issued a joint implementation and preparedness plan for…
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…
Notified Bodies survey on MDR/IVDR certifications and applications
The European Commission has released updated data from the survey conducted among Notified Bodies on…