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...

01. May 2020
The "intended purpose" describes the manufacturers understanding of "WHAT IS THE PRODUCT TO BE USED FOR", which includes the: "Intended use" describing HOW TO USE the product "intended user" describing WHO IS TO USE the product this may be either the patient or the user "environment" describing WHERE or under WHICH CONDITIONS to use the product "indications" explaining WHAT are the medical preconditions for the person using the product, such as diseases or state of health "Medical claims"...

01. May 2020
The Korean MFDS enforced the "In Vitro Diagnostic Medical Device Act" that was published November 28, 2019 as Act No. 163433.

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

23. April 2020
As finally confirmed by the European council and published as "REGULATION (EU) 2020/561 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL": The new date of application for the MDR is now officially 26.05.2021. This allows the manufacturers to to spent more time in intensifying the efforts for the implementation of the increased requirements into their quality systems and Technical Documentations. This does not give the manufacturers extra time to sit and wait for whatever happens after the date of...

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