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
EU Commission Release List of Notified Bodies with their Published Fees
In a significant move to promote transparency and fairness in the medical device market, the European Commission has released a comprehensive list of notified bodies along with their published fees for conformity assessments. This initiative is expected to bring much-needed clarity to the certification process, ensuring that manufacturers, particularly small and medium-sized enterprises (SMEs), can ...
Three New Notified Bodies have been Designated for MDR
There have been three new notified bodies that have been designated for the MDR. The notified bodies are from Italy, Türkiye and Austria. These new additions bring the total number of notified bodies designated under the MDR to 49. More information on these notified bodies can be found using the following links: NB 0068, NB ...
Two New Notified Bodies have been Designated for MDR
April sees the addition of two new notified bodies designated under the Regulation (EU) 2017/745 (MDR). The notified bodies are from Denmark and France and are listed below: NB 2443: TÜV SÜD Danmark NB 0333: AFNOR Certification These new additions bring the total number of notified bodies designated under the MDR to 46. More information ...
Two New Approved Bodies Announced by the MHRA
LNE-GMED (8521) and Scarlet (8536) have just been given approved body status by the Medicines and Healthcare Products Regulatory Agency (MHRA). These new additions bring the total number of UK approved bodies to 9. The full scope of LNE-GMED can be accessed using the following link The full scope of Scarlet can be accessed using ...
New Notified Body has been Designated Under MDR
A new notified body has been designated for the MDR. The new notified body, CESKY METROLOGICKY INSTITUT (NB 1383), is based in Czechia (formally known as the Czech Republic). This new addition brings the total number of notified bodies designated under MDR to 43. More information on the notified body can be found using the ...
EU Commission Release Information on the Applications for Designation as a Notified Body
The EU Commission have released an overview of CAB/NBs at each stage of the designation process. The document shows the different stages of the designation process and how many organisations passed each stage. The data shows that a total of 21 and 62 organisations have lodged applications SANTE F for the IVDR and MDR respectively. ...
