IVD manufacturers of highest risk classes shall be informed of an important template endorsed by…
IVD: What is the status of the Mutual Recognition Agreement between the EU and Switzerland?
From May 26, 2022, the agreement between Switzerland and the European Union on mutual recognition…
New MDCG Guidance on IVDR legacy requirements and Q&A on UDI!
The Medical Device Coordination Group (MDCG) has released two very useful guidances: one concerning the…
IVDR: Harmonised standards for QMS and risk management
May 26, 2022, is an important date for all stakeholders of the IVD sector. The…
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…
IVDR: 7th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! 3EC International a.s. is the…
European Commission: Report on delegated acts
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…
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…