Artikel mit dem Tag "medical device"

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".

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...

30. April 2019
A third procedure simplifying the registration process in Brazil was introduced with the publication of the RDC 270/2019. All Class I products now just need a "NOTIFICATION" with ANVISA. The procedures for market access in Brazil are now: Class I - NOTIFICAÇAO Class II - CADASTRO Class III and IV - REGISTRO

01. April 2019
The GMDN Agency now opened a "Basic" account that allows search in The GMDN database without any charges. Only a user registration is necessary to create the online access. Further information is available on the GMDN agency website. However, you may search by product NAME but it will NOT show you the CODE unless you buy it! Searching for the CODE will show you the NAME and the detailed information. The previous paid accounts will remain available for the previous fees including extra services...

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

13. März 2019
The EUROPEAN COMMISSION published the first Corrigendum for the Medical Device Regulation (EU) 2017/745. The document includes 125 pages with corrections necessary in each of the official languages of the EU. The various translations include a different number of corrections: Languages with 10 corrections: CS, DE, LT,PL, FI Languages with 11 corrections: BG, DA, ET, EL, FR, GA, HR, IT, LV, HU, MT, NL, PT, RO, SK, SL, SV Languages with 14 corrections: EN The German Version of the document...

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