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…
Lithuania: How are medical devices regulated under the MDR/IVDR?
The competent Lithuanian authority has published its implementation law to the Medical Devices Regulation 2017/745 and the In Vitro Devices Regulation 2017/746 by amending several…
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…
MDR Implementation at a national level: Romania
Romania published the Emergency Ordonnance no. 46/11.06.2021 that implements the MDR 2017/745 in the Romanian territory. The Ordonnance provides further clarifications on specific areas of…
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…
Swedish MDR/IVDR implementation law: Fees, penalties and other provisions
Sweden published its implementation law of the Medical Devices Regulation 2017/745, also applying to the In Vitro Devices Regulation 2017/746. This Act establishes several provisions…
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,…