27. March 2020
Der Bundesrat hat heute in seiner Sitzung das Gesetz zur Anpassung des Medizinprodukterechts an die Verordnung (EU) 2017/745 und die Verordnung (EU) 2017/746 (Medizinprodukte-EU-Anpassungsgesetz - MPEUAnpG) und damit das MPDG beschlossen, dass bereits am 5. März vom Bundestag beschlossen hatte, und an den Bundespräsidenten weitergeleitet.

26. March 2020
The Official Journal of the European Union L 090I, Volume 63, dated 25 March 2020 includes a new list of harmonized Standards for: 93/42/EEC Medical Device Directive 90/385/EEC Active Implantable Medical Devices 98/79/EEC In-Vitro Diagnostic Directive but these standards are NOT intended to be used for the MDR! The official wording is: Article 3: The harmonised standards for medical devices drafted in support of Directive 93/42/EEC and listed in Annexes I and II to this Decision may not be used...

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...

23. March 2020
Der Gesundheitsausschuss empfiehlt dem Bundesrat, dem vom Deutschen Bundestag am 5. März 2020 verabschiedeten Medizinprodukte-EU-Anpassungsgesetz - MPEUAnpG, dessen Bestandteil das MPDG ist, zuzustimmen. Der Bundesrat wird sich voraussichtlich in der 988. Sitzung des Bundesrates am 27. März 2020 mit dem Gesetz beschäftigen. Sollte der Bundesrat zustimmen, stünde der Ablösung des MPG nichts mehr im Wege. Allerdings gibt es in der Empfehlung gleichzeitig noch starke Kritik des...

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...

16. March 2020
The Commission updated the MDCG 2019-8 concerning the implant card to version 2. (The previous versionMDCG 2019-8 V1 is no more available on the commission website) As the MDCG Guidance document itself does not have a reference to the version or publication date, it is important to verify the version used. The major difference is the introduction of the UDI Symbol and the requirement to identify the UDI-DI.

16. March 2020
Although the strategy for the transition to the MDR should be "NO CHANGE" on any device that shall be sold utilizing the MDD Certificate after 2020-05-26 (so called "legacy devices") the original wording given in the MDR is "NO significant change". With the newly published MDCG 2020-3 the EU Commission published further clarification on how to interpret the phrase "significant change" for products under Art. 120. Like comparable Guidances in the USA, Canada, Singapore etc. the Guidance is using...

06. March 2020
The newly published consolidated version of the MDR 2017/745 includes now both Corrigenda. English Version download German Version download

13. February 2020
The commission published the eleventh Notified Body for the MDR: "NSAI National Standards Authority of Ireland". As of today the full list of notified bodies under the (EU)2017/745 include: 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...

06. February 2020
With the latest publication by the European Commission DNV Presafe was announced to be the tenth Notified Body for Medical Devices. 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...

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