NSAI To Withdraw from Medical Device Certifications
The National Standards Authority of Ireland (NSAI) has announced its decision to divest its medical-device department to an established testing, inspection and certification (TIC) organisation. The announcement has raised important questions for manufacturers holding CE certificates issued by Notified Body 0050 (NSAI), as well as companies holding NSAI ISO 13485 or Medical Device Single Audit ...
Updated List of Notified Bodies’ Standard Fees
The European Commission has recently updated its list of the standard fees charged by EU Notified Bodies. The revised list includes the fees of Notified Bodies that have been designated since the previous publication, such as Malta Conformity Assessment (MCA). The updated list provides manufacturers with a useful reference for comparing the standard fee structures ...
Video News Summary – May
We’re pleased to announce that this edition of the newsletter as well as future editions will also be available in a video summary format, offering a convenient way to catch up on the latest regulatory updates. To watch the full video summary for the month of May, please click on video below.
New EU Implementing Regulation Establishes Uniform Requirements for Conformity Assessment and Notified Bodies
The European Commission has published a new Implementing Regulation introducing uniform requirements for conformity assessment activities carried out by notified bodies under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The new rules are intended to promote greater harmonisation, predictability, and efficiency within the EU medical device regulatory framework. They ...
New Notified Body has been Designated under IVDR
There has been a new notified body that have been designated under the IVDR. The new notified body: SGS FIMKO OY is from Finland. This new addition brings the total number of notified bodies under the IVDR to 19. More information about this notified body can be found using the following link
New Notified Body has been Designated under MDR
There has been a new notified body that have been designated under the MDR. The new notified body: NOTICE, storitve ugotavljanja skladnosti, d.o.o. is from Slovenia. This new addition brings the total number of notified bodies under the MDR to 51. More information about this notified body can be found using the following link
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 ...
