04. December 2019
The European Commission published a series of documents further clarifying the UDI specifications for each of the four European UDI Issuing Entities.

06. November 2019
Der Nachfolger des Medizinprodukte Gesetzes MPG nimmt immer konkretere Formen an. Jetzt wurde der Gesetzesentwurf für das Medizinprodukte-Durchführungsgesetz MPDG vorgelegt, über den noch Bundesrat und Bundestag abstimmen müssen. Dieser Entwurf löst den Referentenentwurf aus der Mitte des Jahres ab (s. News Blog: Referentenentwurf des MPG Nachfolgers veröffentlicht) Das MDPG ist Teil eines "Omnibus-Gesetzes" dem MPEUAnpG (Medizinprodukte Anpassungsgesetz), in dem alle anfallenden...

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.

01. November 2019
China is step by step implementing an E-submission approach. As of 2019-11-01 applications submitted to NMPA shall be submitted according to the “Technical Guideline on Registration Material Requirements for Electronic Submission System”. (see our News Blog "NMPA published the "Technical Guidance for Submission under the RPS ToC") NMPA as member of the IMDRF prepared this guidance for the e-RPS based on the IMDRF nIVD(MA)ToC. This does not necessarily mean that the applications now need to...

30. October 2019
As confirmed by a statement on the Commission's website the MDR portion of the EUDAMED Database will be operational at the same time as the IVDR portion.The statement concerning the state of play is following: The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore EUDAMED’s launch will be done together for medical and in-vitro...

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.

16. October 2019
The fifth amendment to the Medical devices rules 2017 (may also be called medical devices rules 2019) exempts "testing laboratories of State Governments and Central Government" from the requirements to be accredited by the "National Accreditation Board for Testing and Calibration Laboratories" for a period of two years after this publication.

10. October 2019
Dekra Germany is designated as the first Notified Body under the IVDR. The official designation can be found here.

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