The NANDO database newly listed 29 Notified Bodies under the MDR! TUV NORD Polska Sp. z o.o has been the latest NB notified under the…
MDR: Harmonised standards for QMS and risk management
Since May 26, 2021, the medical device sector experienced a great change. The new Regulation replaced the previous Directive and from that date, manufacturers of…
European Commission: Report on delegated acts
On April 27, 2022, the Directorate-General for Health and Food Safety published a new Report on the exercise of the power to adopt delegated acts…
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 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…