Posts tagged with "Notified Body"



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.

20. August 2019
Only six day after announcing DEKRA as the third Notified Body under the MDR the Commission notifies IMQ ITALY as the fourth Notified Body.

14. August 2019
The third Notified Body under the MDR is there German Organisation Dekra In Stuttgart. The EU Commission published the notification on 2019-08-14, however manufacturers of medical devices are still urgently waiting for further Notified Bodies to be published as we are moving closer to the end of the transition period ending on 2020-05-26. The other two Notified Bodies are: BSI - see our previous news "FIRST MDR Notified Body" TÜV Süd - see our previous news "SECOND Notified Body under the MDR"

22. May 2019
The EU Commission Website now also includes a second Notified Body under the 2017/745: TÜV SÜD Product Service Gmbh Zertifizierstellen TÜV Süd is qualified for the following Conformity assessment procedures: Annex X: Conformity assessment based on type examination Annex IX(I): Conformity assessment based on a quality management system Annex IX(II): Conformity assessment based on assessment of technical documentation Annex XI(A): Conformity assessment based on product quality assurance Annex...

Show more