Posts tagged with "MDR"



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...

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.

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

16. April 2020
The proposal to postpone the date of application for the MDR for one more year has been accepted by the European Parliament:

03. April 2020
The commission published the "Proposal for ... amending Regulation (EU) 2017/745" which will defer certain provision of the Regulation by one year. At the same time it will defer the date of repeal of the directives 90/384 EEC and 93/42/EEC by one year. The Article 1 of the Amendment postpones the implementation of the following aspects form 26. May 2020 to 26. May 2021: Publication date für common specifications for Annex XVI products Publication date für common specifications for...

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...

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...

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