Posts tagged with "Notified Body"



15. May 2020
The commission designated the fourteenth notified body: Intertek Medical Notified Body AB, Sweden. As of today the following Notified Bodies are designated for the MDR: BSI,UK - see News: "FIRST MDR Notified Body - BSI UK." TÜV Süd - see News: "SECOND Notified Body under the MDR - TÜV Süd Germany" DEKRA - see News: "THIRD Notified Body under the MDR - DEKRA Germany" IMQ - see News: "Notified Body number FOUR under the MDR - IMQ Italy" TÜV Rheinland - see News "FIFTH Notified Bodies under...

25. April 2020
With the latest publication on the Nando Website MDC MEDICAL DEVICE CERTIFICATION GMBH Germany is now officially a Notified Body under the MDR. As of today the following Notified Bodies are designated for the MDR: BSI,UK - see News: "FIRST MDR Notified Body - BSI UK." TÜV Süd - see News: "SECOND Notified Body under the MDR - TÜV Süd Germany" DEKRA - see News: "THIRD Notified Body under the MDR - DEKRA Germany" IMQ - see News: "Notified Body number FOUR under the MDR - IMQ Italy" TÜV...

20. March 2020
The twelfth Notified Body for the medical devices regulation is CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. Hungary As of today the following Notified Bodies are designated for the MDR: BSI,UK - see News: "FIRST MDR Notified Body - BSI UK." TÜV Süd - see News: "SECOND Notified Body under the MDR - TÜV Süd Germany" DEKRA - see News: "THIRD Notified Body under the MDR - DEKRA Germany" IMQ - see News: "Notified Body number FOUR under the MDR - IMQ Italy" TÜV...

25. December 2019
The commission designated the German Notified Body MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH as the ninth for the MDR. As of today the following Notified Bodies are designated for the MDR: BSI,UK - see News: "FIRST MDR Notified Body - BSI UK." TÜV Süd - see News: "SECOND Notified Body under the MDR - TÜV Süd Germany" DEKRA - see News: "THIRD Notified Body under the MDR - DEKRA Germany" IMQ - see News: "Notified Body number FOUR under the MDR - IMQ Italy" TÜV...

14. December 2019
Todays publication announces the eighth Notified Body being DEKRA B.V. Following the German headquarter that was already designated in August 2019 as Notified Body for medical devices and in October for IVDs the Dutch organisation is now able to provide its services around the world from the offices in Arnheim, The Netherlands and the subsidiaries in the USA. As of today the following Notified Bodies are designated for the MDR: BSI,UK - see News: "FIRST MDR Notified Body - BSI UK." TÜV Süd -...

06. November 2019
Only one day after the designation of the first dutch notified body BSI's notified body located in the Netherlands was designated as the second dutch and the seventh N .B. for the MDR. It looks like the European MDR is getting more and more driving force with 201 days left (as of today) to the DOA. As of today the following Notified Bodies are designated for the MDR: BSI,UK - see News: "FIRST MDR Notified Body - BSI UK." TÜV Süd - see News: "SECOND Notified Body under the MDR - TÜV Süd...

05. November 2019
The European Commission published the designation for the sixth MDR notified Body: DARE!! Dare!! is the first Dutch MDR notified Body and has the Notified Body number 1912.

30. October 2019
According to the latest publication on the NANDO Website the BSI UK, was designated as the SECOND IVDR Notified Body but as the first with the full scope.

10. October 2019
Dekra Germany is designated as the first Notified Body under the IVDR. The official designation can be found here.

26. September 2019
The fifth Notified Body for the Medical Device Regulation MDR is TÜV Rheinland LGA.

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