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…
IVDR: Harmonised standards for QMS and risk management
May 26, 2022, is an important date for all stakeholders of the IVD sector. The new Regulation on in vitro diagnostic medical devices (IVDR) will…
What is a significant change? New MDCG Guidance for IVD legacy devices
The new Regulation on in vitro medical devices (IVDR) will start to apply on May 26, 2022. For manufacturers, we want to highlight two crucial…
IVDR: 7th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! 3EC International a.s. is the 7th EU Notified Body notified under the Regulation (EU) 2017/746…
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…
IVDR Implementation plan March 2022: What is the status of the main priorities?
The European Commission published its update from March of the Joint implementation and preparedness Plan for Regulation (EU) 2017/746 (IVDR) outlining the priorities and actions to…