Notified Bodies MDR
We would like to share our experience with the Notified Bodies that have been contacted for a CE marking under the MDR. BSI (UK) and DEKRA (DE) don’t take new customers. TUV Süd indicates they need some time but they expect to be ready beginning of 2020. IMQ (IT) cannot be contacted. TUV Rheinald is […]
Notified Bodies websites
Maybe this list may help you a little bit: TÜV Rheinland LGA Products GmbH ; https://www.tuv.com/world/en/eu-medical-device-regulation-mdr-2017-745.html DEKRA Certification GmbH ; https://www.dekra-certification.de/medical-devices-manufacturers/regulation-on-medical-devices.html IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. ; https://www.imq.it/en/eu-directives/regulation-medical-devices-mdr TÜV SÜD Product Service GmbH Zertifizierstellen; https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-regulation BSI Assurance UK Ltd; https://www.bsigroup.com/en-GB/medical-devices/our-services/ce-marking/
Symbols
The new Regulation requires manufacturers to add new information on the label: the fact that the device is a medical device, that the device contains materials of animal origin… The MedTech Europe has published a guideline. The proposed symbols are not yet official. We can hope they will be incorporated in the revision of ISO […]
21 August 2019
There are now 4 notified bodies for the Medical Devices Regulation: BSI (UK), DEKRA (DE), TUV Sud (DE) and IMQ (IT). BSI wrote that they accept new applications but it seems that priority is given to existing customers. The list of notified bodies is available on the NANDO website.
BSI
BSI is now accepting applications for MDR. This service will focus on their existing UK (0086) and NL (2797) clients.
Becomes the second notified body
With BSI (UK), TÜV SÜD (DE) becomes the second notified body to be certified under the new Medical Devices Regulation (MDR). Still nobody for the IVDR
European Commission
European Commission has prepared a Corrigendum to extend the transition period for the medical devices that were classified in Class I according to MDD and that become Class II or higher in the new Regulation. If it is confirmed, it will be a good news for the medical software manufacturers.
