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…
Hungary: MDR implementation at national level
The Regulation (EU) 2017/745 on medical devices is implemented into Hungarian national legislation through amended…
Legacy devices: new MDCG guidance on NB surveillance & QMS
The Medical Device Coordination Group (MDCG) has published an important guidance establishing the activities to…