The Medical Devices Coordination Group (MDCG) has released this August a guidance on the designation, re-assessment and notification under MDR & IVDR of conformity assessment…
MDR: 32 Notified Bodies on NANDO
The NANDO database newly listed 32 Notified Bodies under the MDR! BUREAU VERITAS ITALIA S.P.A.Viale Monza, 347 20126 – MILANO (MI)Country : Italy Phone :…
Implementation Rolling Plan July 2022 (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746 with the list of implementing acts and actions to take…
MDR: 31 Notified Bodies on NANDO
The NANDO database newly listed 31 Notified Bodies under the MDR! AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS has been the latest NB notified under the…
EUDAMED Delayed!
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 FSC: CAMD Q&A
The Competent Authorities for Medical Devices (CAMD) network issued on June 2022 a document on Questions and Answers regarding Free Sales Certificates (FSC) and Article…
MDCG & CAMD: Time to act towards MDR compliance
The Medical Device Coordination Group (MDCG) has issued this June 2022, a position paper on the need for manufacturers to ensure timely compliance with MDR…
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…
New MDCG Guidance on IVDR legacy requirements and Q&A on UDI!
The Medical Device Coordination Group (MDCG) has released two very useful guidances: one concerning the application of IVDR requirements to “legacy devices” and devices placed…