Posts tagged with "(EU) 2017/745"



06. January 2020
The European Commission published the first EU Guidance on Cybersecurity: MDCG 2019-06. This document addresses the aspects: Basic Cybersecurity Concepts Secure Design and Manufacture Documentation and Instructions for use Post-Market Surveillance and Vigilance The last chapter compares the current state of the existing guidances under the headline: Other Legislation and guidance: EU and International For the practical approach to the question what are the known hazards on cybersecurity the...

25. December 2019
The commission designated the German Notified Body MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH as the ninth for 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...

18. December 2019
The guidance MDCG 2019-15 includes a comprehensive overview of the manufacturers‘ obligations for all Class I products. It also gives some further clarification concerning the "Authorized Representative": A manufacturer with a registered place of business outside the Union will designate a sole authorised representative, at least per each generic device group, according to a written mandate. At the same time it includes further specifications of the manufacturers' obligations: The...

16. December 2019
The long awaited second corrigendum (MDR COR 2) english Version of the COR 2 German Version of the COR 2 other languages Version of the COR 2 is now finally "deemed to be approved" by the EU-Parliament as there was no further request on voting on the ENVI Document during the meeting held on December 16th in Straßburg. It was handled as TOP 6 of that meeting and results with the following statement in the protocol: 6. Corrigenda (Rule 241) The ENVI and INTA Committees had forwarded the...

14. December 2019
Todays publication announces the eighth Notified Body being DEKRA B.V. Following the German headquarter that was already designated in August 2019 as Notified Body for medical devices and in October for IVDs the Dutch organisation is now able to provide its services around the world from the offices in Arnheim, The Netherlands and the subsidiaries in the USA. As of today the following Notified Bodies are designated for the MDR: BSI,UK - see News: "FIRST MDR Notified Body - BSI UK." TÜV Süd -...

12. December 2019
In the MDCG 2019-13 the EU Commission publishes further details on the sampling of the technical documentation for review by the Notified Body during the conformity assessments of Medical devices and IVDs. The guidance explains how to identify product categories ( (for Class IIa and Class B) and generic product groups (for Class IIb and Class C) . Manufacturers will need to utilize two "coding" systems: The MDA/MDN codes (MDR) or IVR codes (IVDR) according to Regulation (EU) 2017/2185, which is...

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
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.

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...

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