New Notified Body has been Designated under the IVDR
There has been a new notified body that have been designated under the IVDR. The new notified body: POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. is from Poland. This new addition brings the total number of notified bodies to 18. More information about this notified body can be found using the following link
UPDATE: Notified Bodies Survey on Certifications and Applications
The EU Commission has updated the current state of MDR/IVDR applications with the notified bodies. This new update is concerning a period ending in October 2024. The results have been documented in a .pdf power point which is split up into 4 sections: MDR Statistics The MDR survey results concerning a period ending on October ...
New Notified Body has been Designated Under IVDR
There has been a new notified body that has been designated under the IVDR. The notified body is from Norway. The details of this notified bodies can be seen below: More information about this notified body can be found using the following link
Three New Notified Bodies have been Designated Under IVDR
There has been a total of 3 new notified bodies that have been designated under the IVDR. The notified bodies are from Belgium, Spain and Italy respectively. The details of these notified bodies can be seen below: These new additions bring the total number of notified bodies to 16. More information about these notified bodies ...
UPDATE: New UK Approved Body
A new UK Approved Body has been designated. The mew UK Approved body is Eurofins E&E CML Limited and isbased in Ellesmere Port UK. The current list of UK Approved Bodies can be seen in the table below, that being said, please be aware that the list is always being updated. UK Approved Body Number ...
Various European Organisations Publish Joint Discussion Paper on the Future Governance of Medical Technologies in Europe
This collaborative discussion paper builds upon MedTech Europe’s 2023 position paper and presents a unified perspective from the European medical technology industry, represented by MedTech Europe, AESGP, COCIR, EEAR, EUROM, and FIDE. It advocates for a reform in the governance of the European regulatory system for medical technologies. The document underscores the need to establish ...
MEDTECH Europe Issue Position Paper on Submission of vigilance reports to Notified Bodies under EU MDR & IVDR
Vigilance reports are a critical component of the post-market surveillance (PMS) system established by the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) to ensure medical device safety. Manufacturers are required to systematically collect, analyse, and review real-world data on devices placed on the EU market. ...
UPDATE: UK Approved Bodies
The medical device scope of the UK Approved Body BSI Assurance UK Ltd and DEKRA Certification UK Ltd havebeen updated. In addition, DEKRA Certification UK Ltd in-vitro diagnostic medical devices scope. The current list of UK Approved Bodies can be seen in the table below, that being said, please be aware that the list is ...
TEAM NB Publish Position Paper Regarding the Transfer Agreement for the Surveillance of Legacy Devices for IVD’s
Pursuant to Regulation (EU) 2024/1860, the arrangements for the transfer of the surveillance from the notified body that issued the certificate to the notified body designated in accordance shall be clearly defined in an agreement between the manufacturer and the notified body designated and where practicable, the notified body that issued the certificate. In attempts ...
New Notified Body has been Designated under the IVDR
A new notified body has been designated for the IVDR. The new notified body, ISTITUTO SUPERIORE DI SANITA’ (NB 0373), is based in Italy. This new addition brings the total number of notified bodies designated under IVDR to 13. More information on the notified body can be found using the following link
