Posts tagged with "(EU) 2017/745"



08. July 2020
The EU-Commission published today the designation of the fifteenth Notified Body under the MDR: GMED, France (Designation Scope) 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...

19. May 2020
Nachdem die Anwendung der Europäischen Verordnung für Medizinprodukte (MDR) um ein Jahr auf den 26.Mai 2021 verschoben wurde, hat der Bundesrat auch die Anwendung des neuen " Medizinprodukterecht-Durchführungsgesetzes" (MPDG) um ein Jahr verschoben. Die Fristverlängerung erfolgt etwas umständlich über das: "Zweites Gesetz zum Schutz der Bevölkerung bei einer epidemischen Lage von nationaler Tragweite" Der Artikel 17(2) des Gesetzes lautet: (2) Artikel 17 des...

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...

28. April 2020
The Team NB posted a comment on their website concerning the postponed DOA for the MDR. The members' concern is the missing awareness that by postponing the DOA the remaining time for the full implementation is shortened by one year. This may lead to piles of applications with the notified bodies not being finished in the remaining period of 3 instead of 4 years.

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...

24. April 2020
Today the Commission published for new MDCG Guidance documents: + MDCG 2020-8 Guidance on PMCF Evaluation Report Template April 2020 + MDCG 2020-7 Guidance on PMCF Plan Template April 2020 + MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices April 2020 + MDCG 2020-5 Guidance on Clinical Evaluation – Equivalence April 2020

24. April 2020
The consolidated Version of the (EU)2017/745 (MDR) was published. The consolidated text includes: Corrigendum 1 - (COR1) including minor typo removals 2019-05-03 Corrigendum 2 - (COR2) including the postponed date of application (DOA) for Class I products that require the involvement of a notified body. 2019-12-27 see our News "Consolidated Version MDR including the second Corrigendum published" Modification 1 - (M1) including the postponed DOA for all other products 2020-04-24

16. April 2020
The proposal to postpone the date of application for the MDR for one more year has been accepted by the European Parliament:

25. March 2020
The commission is working on proposals to postpone the date of application for the MDR for one year! This information was presented on a video recorded during a Q&A session of the Read-out of the College meeting of 25/03/2020. Details will follow as soon as the commission publishes the proposal that need to be passing through the EU-Council and EU-Parliament There were already several initiatives to ask the commission for extension of the date of application. This is the link to a letter...

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...

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