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...

01. September 2020
The MDSAP Council published the new "Audit Approach": MDSAP AU P0002.005. This document is combining the previous "Audit Model" and the "Companion Document" into a single source. At the same time the new "audit approach" replaces the previous documents latest 2020-09-30. It is important to notice that the text of the "audit tasks" and "criteria" have not been changed. The new document now includes 2 new annexes with further information concerning the national legislation of the member...

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...

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.

Show more