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. ...
Team Notified Body Issue Call to Action for Manufacturers of Class D In-Vitro Diagnostic Medical Devices
In order to address the slow transition and prevent shortages of IVDs on the market, the amending regulation (EU) 2022/112 of 25 January 2022 introduced a stepped extension of transition periods based on the classification of the IVD. While the amending regulation has provided additional transitional time, the first deadline of 26 May 2025 for ...
Three New Notified Bodies have been Designated under the MDR.
November sees the addition of three new notified bodies designated under the Regulation (EU) 2017/745 (MDR). Two of these notified bodies are from Türkiye and one is from the Netherlands. These are listed below: These new additions bring the total number of notified bodies designated under the MDR to 42. More information regarding the notified ...
Current State of MDR/IVDR Applications with Notified Bodies
The EU Commission has updated the current state of MDR/IVDR applications with the notified bodies. The results have been documented in a .pdf power point which is split up into 3 sections: About the study and survey, Survey results for medical devices, Survey results for in vitro diagnostic medical devices. From the results, one can ...
Three new UK Approved Bodies announced by the MHRA
The MHRA has designated three new UK approved bodies, almost doubling it’s capacity for the certification of medical devices. There are now a total of seven UK approved bodies in the UK. These approved bodies play an important role in the medical device industry by helping manufacturers to get their device on the market and ...
