On April 27, 2022, the Directorate-General for Health and Food Safety published a new Report…
Dutch MDR/IVDR implementation: Medical Devices Regulation and Medical Devices Act
The Dutch Regulation of the Minister for Medical Care (cited as the Dutch Medical Devices…
MDR Borderline guidance between medical devices and medicinal products published!
The MDCG has released new guidance on borderline cases between medical devices and medicinal products under the Medical…
EU and Turkey: Agreement on medical devices
Customs Union The Ankara Agreement outlines the cooperation between Turkey and the European Economic Community…
EUDAMED: NB, Certificates & UDI/Device registration – Useful documents
Notified Bodies and Certificates The European Commission has released updated documents on the technical documentation…
MDR: 28 Notified Bodies on NANDO
The NANDO database newly listed 28 Notified Bodies under the MDR! SLOVENIAN INSTITUTE OF QUALITY…
Summary of safety and clinical performance: MDCG Update
The MDCG has updated its Guidance on the Summary of Safety and Clinical Performance (SSCP),…
Austria: MDR Implementation at national level
Austria has implemented Regulation 2017/745 through the Medical Devices Act in force from 30 June…
Swiss and EU relations: impact on medical devices
The agreement between Switzerland and the European Union on mutual recognition in relation to conformity…
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…