The NANDO database newly listed 36 Notified Bodies under the MDR! ICIM S.P.A. has been…
MDCG Position Paper on Hybrid Audits
Implemented during the pandemic and helped by new technologies, hybrid audits have become more frequent.…
MDR & IVDR national implementation: Austria
The Austrian Medical Device Act 2021 implements the EU Regulations on medical devices and in…
Annex XVI devices: Common specifications and reclassification
The official journal of the European Union now includes two Commission Implementing Regulations on Annex…
MDR: 35 Notified Bodies on NANDO
The NANDO database newly listed 35 Notified Bodies under the MDR! INSTITUT PRO TESTOVÁNI A…
Clinical investigations under the MDR: New Revision of MDCG on Safety reporting
The Medical Devices Coordination Group (MDCG) released on October 2022 a new revision to their MDCG…
Guidance on EAR: obligations and responsibilities under the Regulations
In October 2022, the Medical Device Coordination Group (MDCG) published a new Guidance on obligations…
Medical Devices in the UK: extension for CE marked devices
With Brexit, the legislation of the European Union does not apply in the United Kingdom…
Notified Bodies: requirements, certifications, and applications
Several publications related to notified bodies marked October 2022. Among others, the Medical Device Coordination…
Updated EC Implementation Rolling Plan (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746…