In October 2022, the Medical Device Coordination Group (MDCG) released a new update to its…
Guidance on EAR: obligations and responsibilities under the Regulations
In October 2022, the Medical Device Coordination Group (MDCG) published a new Guidance on obligations…
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…
MDR & IVDR national implementation: Italy
In August 2022, Italy published the national law implementing the EU Regulations on medical devices…
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…
NB Position Papers on Cybersecurity and “Off-Label” Use
Team-NB recently published various position papers. Two of the latest publications concern Cybersecurity and “Off-Label”…
NB Position Papers on Class D devices in absence of EURLs and time to implement guidance documents
Between September and October 2022, Team-NB published various position papers. One of them addresses class…
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…
Upcoming MDR national implementation laws: Portugal
The applicable national implementation in Portugal will be stated under the Decree-Law ensuring the implementation of…