The new draft act available on the website of the European Commission aims at regulating active products without an intended medical purpose falling under Annex…
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 :…
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: 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…
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…
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…
Legacy devices: new MDCG guidance on NB surveillance & QMS
The Medical Device Coordination Group (MDCG) has published an important guidance establishing the activities to be performed by notified bodies while carrying out their surveillance…