The European Commission has announced a delay of the full functionality of the European database on medical devices (EUDAMED) and a new update of the…
MDR: 30 Notified Bodies on NANDO
The NANDO database newly listed 30 Notified Bodies under the MDR! Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbH has been the latest NB notified…
New Version of the Italian CND is now available!
On January 24, 2022, the Italian Official Journal published the Decree aiming to amend and update the Medical Device National Classification (CND). The CND groups…
MDR: 29 Notified Bodies on NANDO
The NANDO database newly listed 29 Notified Bodies under the MDR! TUV NORD Polska Sp. z o.o has been the latest NB notified under the…
MDR: Harmonised standards for QMS and risk management
Since May 26, 2021, the medical device sector experienced a great change. The new Regulation replaced the previous Directive and from that date, manufacturers of…
IVDR: 7th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! 3EC International a.s. is the 7th EU Notified Body notified under the Regulation (EU) 2017/746…
EUDAMED: NB, Certificates & UDI/Device registration – Useful documents
Notified Bodies and Certificates The European Commission has released updated documents on the technical documentation relevant for Notified Bodies and the related registration of certificates…
MDR: 28 Notified Bodies on NANDO
The NANDO database newly listed 28 Notified Bodies under the MDR! SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY – SI has been the latest NB notified…
Swiss and EU relations: impact on medical devices
The agreement between Switzerland and the European Union on mutual recognition in relation to conformity assessment (MRA) of medical devices started in June 2002 and…