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…
Swissdamed: Database for Medical Devices in Switzerland
In Switzerland, Swissmedic enforces the registration of economic operators and medical devices. For this purpose,…
IVD legacy devices: MDCG Guidance on appropriate surveillance
The Medical Device Coordination Group (MDCG) has issued this September 2022 new guidance on the…
MDR & IVDR: Manual on borderline classification issued!
In September 2022, the Medical Devices Coordination Group (MDCG) issued a manual addressing borderline and…
Call for EU reference laboratories to Member States
In July 2022, the European Commission opened its call for Member States to submit applications…
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…
MDR & IVDR national implementation: Finland
The national implementation of the Medical Devices Regulation 2017/745 (MDR) and In Vitro Devices Regulation 2017/746 (IVDR)…
Notified Body Designation process: MDCG guidance
The Medical Devices Coordination Group (MDCG) has released this August a guidance on the designation,…