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REGULATION (EU) 2017/ 745 OF THE EUROPEAN PARLIAMENT

05-May-2017 REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices amending Directive 2001/83/EC



B REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT

REGULATION (EU) 2017/745 OF THE EUROPEAN. PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices amending Directive 2001/83/EC



Official Journal L117

05-May-2017 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC



MDCG 2020-10/1 Safety reporting in clinical investigations of

This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU). 2017/745.



COMMISSION IMPLEMENTING REGULATION (EU) 2017/ 2185 - of

24-Nov-2017 Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical.



regulation (eu) 2020/561 of the european parliament and of the

23-Apr-2020 At the same time Regulation (EU) 2017/745 sets high standards of quality and safety for medical devices in order to meet common safety concerns ...



Questions & Answers for applicants marketing authorisation holders

23-Jun-2021 Products which combine a medicinal product (or substance) and a medical device are regulated either by Regulation (EU) 2017/745 or Directive ...



B REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT

REGULATION (EU) 2017/745 OF THE EUROPEAN. PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices amending Directive 2001/83/EC



Corrigendum to Regulation (EU) 2017/745 of the European

27-Dec-2019 Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive ...



MDCG 2021-6 Regulation (EU) 2017/745 – Questions & Answers

This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of.



[PDF] REGULATION (EU) 2017/ 745 OF THE EUROPEAN PARLIAMENT

5 mai 2017 · REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices amending Directive 2001/83/EC 



[PDF] RÈGLEMENT (UE) 2017/ 745 DU PARLEMENT EUROPÉEN ET DU

5 mai 2017 · (5) Pour favoriser la convergence de la réglementation à l'échelle internationale afin de contribuer à instaurer un niveau élevé de sécurité 



Download MDR - Medical Device Regulation

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive Language PDF HTML



[PDF] Guide concernant lapplication du règlement (UE) 2017/745 relatif

Le règlement (UE) 2017/745 relatif aux dispositifs médicaux est d'application depuis le 26 mai 2021 Ce règlement1 va renforcer les règles relatives aux 



Complete Download Section mdi Europa

15 avr 2023 · MDR – Medical Devices Regulation (EU) 2017/745 – including Corrigendum PDF file MDR [2000 KB]; IVDR – In Vitro Diagnostic Medical Devices 



[PDF] Medical Device Regulation (EU) 2017/745 section 5 specific - SGS

format (i e Text recognition PDF or Microsoft word format) Regulation (EU) 2017/745 and to inform SGS Belgium in writing



The European Medical Device Regulation 2017/745/EU: Changes

PDF The European Medical Device Regulation 2017/745 (MDR) will be operational starting in May 26 2020 The regulation has significant economic impact



The European Union Medical Device Regulation – Regulation (EU

A second corrigendum to Regulation (EU) 2017/745 was published in the Official Journal of the European Union Probably the most significant change being the 



[PDF] MDR 2017/745 - New EU Regulation for Medical Devices - DiVA portal

26 mai 2020 · 3 3 Events Leading Up to the Development of a New Regulation MDR 14 3 4 Medical Device Regulatory 2017/745



Nouvelle réglementation sur les dispositifs médicaux - Swissmedic

Règlement (UE) 2017/745 relatif aux dispositifs médicaux y compris 1er/2e rectificatif et (Regulation on in-vitro diagnostic medical devices IVDR)

:

This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability

for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official

Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links

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