The MDCG has released new guidance on borderline cases between medical devices and medicinal products under the Medical Devices Regulation 2017/745. This guidance addresses several concepts such as…
EU and Turkey: Agreement on medical devices
Customs Union The Ankara Agreement outlines the cooperation between Turkey and the European Economic Community (ECC). Already established in 1963, the Agreement creates a Customs…
EUDAMED: NB, Certificates & UDI/Device registration – Useful documents
Notified Bodies and Certificates The European Commission has released updated documents on the technical documentation relevant for Notified Bodies and the related registration of certificates…
MDR: 28 Notified Bodies on NANDO
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…
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 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…
MDR: 27 Notified Bodies on NANDO
The NANDO database newly lists 27 Notified Bodies under the MDR! ITALCERT SRL has been the latest NB notified under the Regulation (EU) 2017/745 on…
MDR: New harmonised standards
The Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices,…