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…
IVDR progressive roll-out has been officially published!
The Official Journal of the European Union (OJEU) has officially listed the amendment of the In Vitro Devices Regulation 2017/746, extending the transitional period for…
Notice to third country manufacturers of SARS-CoV-2 IVDs
The competent national authorities have identified several common issues while implementing market surveillance activities (presented below) to ensure the compliance of IVDs with the applicable…
IVDR: New harmonised standards
The Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products,…
The European Parliament and the Council of the EU adopt IVDR progressive roll-out!
The two co-legislators of the European Union: the European Parliament and the Council of the EU have commonly agreed to delay the date of application…
Distributors and importers: new MDCG Q&A
The MDCG has published a new Q&A document with the aim to provide more details on the implementation of Articles 13 and 14 and other…
EXPAMED publishes its new Opinion on Performance Evaluation Consultation procedure (PECP)
The expert panel on medical devices and in-vitro diagnostic devices (EXPAMED) has published a new Opinion in the context of the performance evaluation consultation procedure…