From May 26, 2022, the new Regulation on in vitro medical devices applies! IVDR fully applies from May 26, 2022 CE Certificates issued under the…
IVD: What is the status of the Mutual Recognition Agreement between the EU and Switzerland?
From May 26, 2022, the agreement between Switzerland and the European Union on mutual recognition for the market of in vitro diagnostic medical devices will…
IVDR: Harmonised standards for QMS and risk management
May 26, 2022, is an important date for all stakeholders of the IVD sector. The new Regulation on in vitro diagnostic medical devices (IVDR) will…
What is a significant change? New MDCG Guidance for IVD legacy devices
The new Regulation on in vitro medical devices (IVDR) will start to apply on May 26, 2022. For manufacturers, we want to highlight two crucial…
IVDR: 7th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! 3EC International a.s. is the 7th EU Notified Body notified under the Regulation (EU) 2017/746…
EUDAMED: NB, Certificates & UDI/Device registration – Useful documents
Notified Bodies and Certificates The European Commission has released updated documents on the technical documentation relevant for Notified Bodies and the related registration of certificates…
Swiss and EU relations: impact on medical devices
The agreement between Switzerland and the European Union on mutual recognition in relation to conformity assessment (MRA) of medical devices started in June 2002 and…
IVDR: Verification of class D IVDs by notified bodies
The Medical Device Coordination Group (MDCG) has published a Guidance establishing the activities of notified bodies in the verification process of class D IVD devices.…