The Medical Devices Coordination Group (MDCG) released in December 2022 a new update to their manual on borderline and classification for medical devices under MDR…
MDCG template for substantial modification of performance study
Performance evaluation data can derive from performance studies. Data generated in performance studies must be reliable and robust, as stated in the Regulation on IVD…
MDCG templates for performance study application and PMPF study notification
In December 2022, the Medical Device Coordination Group published various templates on performance study application and PMPF (Post Market Performance Follow-up) study notification. Documents for…
MDCG Position Paper on Hybrid Audits
Implemented during the pandemic and helped by new technologies, hybrid audits have become more frequent. A hybrid audit is an audit conducted on site and…
MDR & IVDR national implementation: Austria
The Austrian Medical Device Act 2021 implements the EU Regulations on medical devices and in vitro diagnostic medical devices in Austria. The Austrian Federal Office…
MDCG Joint Implementation plan on IVDR
In October 2022, the Medical Device Coordination Group (MDCG) released a new update to its joint plan on the preparedness and implementation of the In…
Guidance on EAR: obligations and responsibilities under the Regulations
In October 2022, the Medical Device Coordination Group (MDCG) published a new Guidance on obligations and responsibilities of the Authorised Representative. According to the Regulations…
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…
NB Position Papers on Technical Documentation and Transfer Agreement
In October 2022, Team-NB published several position papers. The first position paper concerns the technical documentation to provide to Notified Bodies, whereas a second one…