Artikel mit dem Tag "MDR"



25. August 2019
Das Bundesministerium für Gesundheit hat den Referentenentwurf für das "Medizinprodukte-Anpassungsgesetz-EU – MPAnpG-EU" veröffentlicht. Mit diesem MPAnpG-EU wird das erstmals das "Medizinprodukte Durchführungs Gesetz (MDG)" dargestellt, das laut Entwurf: Das Medizinprodukte-Durchführungsgesetz ersetzt mit seinem Inkrafttreten am 26. Mai 2020 das Medizinproduktegesetz (MPG), welches zu diesem Zeitpunkt außer Kraft tritt (Anmerkung: zumindest für Medizinprodukte, die unter die (EU)...

21. August 2019
The "Consolidated MDR" text composing of: (EU)2017/745 MDR as published on 2017-04-05 plus the first corrigendum COR1 as published on 2019-05-03 is available on the Commission's Website in the official languages of the Union. Remark: The Commission points out that "text is meant purely as a documentation tool and has no legal effect".

20. August 2019
Only six day after announcing DEKRA as the third Notified Body under the MDR the Commission notifies IMQ ITALY as the fourth Notified Body.

14. August 2019
The third Notified Body under the MDR is there German Organisation Dekra In Stuttgart. The EU Commission published the notification on 2019-08-14, however manufacturers of medical devices are still urgently waiting for further Notified Bodies to be published as we are moving closer to the end of the transition period ending on 2020-05-26. The other two Notified Bodies are: BSI - see our previous news "FIRST MDR Notified Body" TÜV Süd - see our previous news "SECOND Notified Body under the MDR"

01. Juli 2019
The MDCG is giving further guidance concerning the ‘person responsible for regulatory compliance’ (PRRC) The document MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC) explains several specific questions around the PRRC, such as: Can the PRRC be located outside the EU? Can one individual be the PRRC for a manufacturer and its authorised...

11. Juni 2019
In addition to the three UDI issuing entities already mentioned in the MDR Article 120,12 the EU Commission just announced a fourth entity. Following the COMMISSION IMPLEMENTING DECISION (EU) 2019/939 dated June 6th 2019 there will be the following four issuing entities for the UDI codes: (a) GS1 AISBL (b) Health Industry Business Communications Council (HIBCC) (c) ICCBBA (d) Informationsstelle für Arzneispezialitäten — IFA GmbH

07. Juni 2019
The latest MDCG Guidance includes "Questions and Answers, relating to Notified Bodies" for the application of the MDR. Although the focus as identified in the title are the Notified Bodies some interesting information for the manufacturers can be found as well. Just to name two topics: Auditing of subcontractors OBL situation under the MDR

23. Mai 2019
The EU Commission posted a new version of the Borderline Guidance with revision 1.22 New Amendments in the current version are: Automated external defibrillator storage units If it is intended to be used with an individual AED to store it in the environmental conditions It should be considered an accessory Lubricants intended for alleviation of vaginal dryness According to Rule 5, these lubricants should be classified in class IIa Medication decision support software The software is intended to...

22. Mai 2019
The EU Commission Website now also includes a second Notified Body under the 2017/745: TÜV SÜD Product Service Gmbh Zertifizierstellen TÜV Süd is qualified for the following Conformity assessment procedures: Annex X: Conformity assessment based on type examination Annex IX(I): Conformity assessment based on a quality management system Annex IX(II): Conformity assessment based on assessment of technical documentation Annex XI(A): Conformity assessment based on product quality assurance Annex...

26. März 2019
Among the 14 corrections (in the english version) recently introduced to the MDR (EU) 2017/745 one has a major impact to the review of the Technical documentation

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