Following the publication of the latest amendment to the Medical Devices Regulations (MDR and IVDR),…
MDCG Guidance on Period Safety Update Report (PSUR) under MDR
Manufacturers of class IIa, class IIb, and class III medical devices have to prepare a…
MDCG Position Paper on extension period for legacy devices
The previous 2024 deadline worried the medical devices sector. With foreseeable market disruptions and negative…
Notified Bodies: requirements, certifications, and applications
Several publications related to notified bodies marked October 2022. Among others, the Medical Device Coordination…
MDR: 34 Notified Bodies on NANDO
The NANDO database newly listed 34 Notified Bodies under the MDR! ENTE CERTIFICAZIONE MACCHINE SRL…
MDR: 33 Notified Bodies on NANDO
The NANDO database newly listed 33 Notified Bodies under the MDR! POLSKIE CENTRUM BADAN I…
Reclassification of products without an intended medical purpose: European Commission publishes a draft act
The new draft act available on the website of the European Commission aims at regulating…
MDR: 32 Notified Bodies on NANDO
The NANDO database newly listed 32 Notified Bodies under the MDR! BUREAU VERITAS ITALIA S.P.A.Viale…
MDR: 31 Notified Bodies on NANDO
The NANDO database newly listed 31 Notified Bodies under the MDR! AGENCIA ESPAÑOLA DE MEDICAMENTOS…
MDR: 30 Notified Bodies on NANDO
The NANDO database newly listed 30 Notified Bodies under the MDR! Berlin Cert Prüf- und…