The Medical Devices Coordination Group (MDCG) released on October 2022 a new revision to their MDCG guidance on safety reporting in clinical investigations of medical devices…
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 anymore. Currently, the Medical Device Regulations 2002 (UK MDR 2002)…
Notified Bodies: requirements, certifications, and applications
Several publications related to notified bodies marked October 2022. Among others, the Medical Device Coordination Group (MDCG) published a Q&A document on requirements relating to…
Updated EC Implementation Rolling Plan (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/actions to take with different…
MDR & IVDR national implementation: Italy
In August 2022, Italy published the national law implementing the EU Regulations on medical devices and IVD medical devices. Since September 28, 2022, Legislative Decrees…
MDR: 34 Notified Bodies on NANDO
The NANDO database newly listed 34 Notified Bodies under the MDR! ENTE CERTIFICAZIONE MACCHINE SRL has been the latest NB notified under the Regulation (EU)…
NB Position Paper: What are Hybrid Audits and how to perform them?
In September 2022, Team-NB published a position paper on hybrid audits for quality management system assessments of medical devices under MDR/IVDR. Team-NB is the European…
Upcoming MDR national implementation laws: Portugal
The applicable national implementation in Portugal will be stated under the Decree-Law ensuring the implementation of MDR 2017/745, a decree on MDR clinical investigations and IVDR performance…
MDR: 33 Notified Bodies on NANDO
The NANDO database newly listed 33 Notified Bodies under the MDR! POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.ul. Puławska 469 02-844 WarszawaCountry : Poland Phone :…
MDCG position paper on Notified Body capacity and availability of medical devices and IVDs!
The Medical Device Coordination Group (MDCG) released a new position paper on the transition to the Medical Devices Regulation (MDR) and In Vitro Devices Regulation (IVDR) this…