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 2025. 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 the MDR
The first Notified Body under the Medical Device Regulation (MDR) has officially opened in Malta, marking an important milestone for both the local life sciences sector and the wider European medical device landscape. In simple terms, a Notified Body (NB) designated under the Medical Device Regulation (EU) 2017/745 is an independent, third-party organisation appointed by ...
New Notified Body has been Designated for MDR
March sees the addition of a new notified body designated under the Regulation (EU) 2017/745 (MDR). The notified body is from Sweden and is listed below: This new addition brings the total number of notified bodies designated under the MDR to 44. More information regarding this new notified body can be found using the following ...
New Notified Body Designated for IVDR
The 11th Notified Body for Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices has been included in the list of designated Notfied bodies available in the European Commission’s NANDO information system. For the NANDO information system, please click here. For more information ...
Notified Body Response Times and Availability
The limited capacity of the Notified Bodies is no secret and is expected to be further affected due to the newly accepted amendment. This can have a substantial effect on the response times and availability for work of the Notified Bodies, which ultimately means that the manufacturer must wait longer than usual for conformity assessments. ...
