20. October 2020
The newly published Inforgraphic on "Actor roles and SRN" explains the future structure of the Single Registration Number (SRN).
16. September 2020
The Slovakian organization "3EC International's s.a." was designated as the 17th notified body under the MDR. The following 16 Notified Bodies were previously designated under 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...
20. August 2020
The Commission published the second implementing act under the MDR: COMMISSION IMPLEMENTING REGULATION (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices The implementing act includes further specifications concerning the reprocessing activities, responsibilities and documentation.
08. August 2020
Congratulations to Dr. Thomas Feldmann and his entire team for finally being designated as a notified body under the MDR with the scope as shown on the designation. There are now 16 Notified Bodies designated under 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"...
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