The NANDO database newly listed 28 Notified Bodies under the MDR! SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY – SI has been the latest NB notified…
Summary of safety and clinical performance: MDCG Update
The MDCG has updated its Guidance on the Summary of Safety and Clinical Performance (SSCP), which is especially relevant for manufacturers of Class III and…
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.…
Legacy devices: new MDCG guidance on NB surveillance & QMS
The Medical Device Coordination Group (MDCG) has published an important guidance establishing the activities to be performed by notified bodies while carrying out their surveillance…
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…
Public consultation on MDR Annex XVI Implementing Regulation open!
The European Commission has opened the public consultation on the draft Commission Implementing Regulation (CIR) and its Annex concerning the common specifications for products listed…
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…