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…
European Commission: Report on delegated acts
On April 27, 2022, the Directorate-General for Health and Food Safety published a new Report on the exercise of the power to adopt delegated acts…
EU and Turkey: Agreement on medical devices
Customs Union The Ankara Agreement outlines the cooperation between Turkey and the European Economic Community (ECC). Already established in 1963, the Agreement creates a Customs…
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…
IVDR Implementation plan March 2022: What is the status of the main priorities?
The European Commission published its update from March of the Joint implementation and preparedness Plan for Regulation (EU) 2017/746 (IVDR) outlining the priorities and actions to…
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.…
Public Consultation on Common Specifications for IVDR Class D devices
The European Commission has initiated the public consultation on the Draft Implementing Regulation (CIR) and its Annex concerning the common specifications for Class D devices…
IVDR Implementation plan February 2022: What is the status of the main priorities?
108 days ahead of the date of application, the European Commission published the updated Joint implementation and preparedness Plan for Regulation (EU) 2017/746 (IVDR) outlining…