Theme Implant Card Target Audience Manufacturers Products Concerned Implantable MD Regulatory reference MDR (EU) 2017/745 Article 18 Documents mentioned ISO database (Online Browsing Platform) ISO 15223-2 ISO/IEC 7810 ID-1 This document clarifies the contents...
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MDCG 2019-7 Rev.1 : Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) – June 2019
Theme Person responsible for regulatory compliance - PRRC Target Audience Manufacturers and Authorised representative Products Concerned MD, IVD Regulatory reference MDR (EU) 2017/745 and IVDR (EU) 2017/746 Article 15 Documents mentioned Commission Recommendation...
MDCG 2019-6 Rev. 4 : Questions and answers : Requirements relating to notified bodies – October 2019
Theme Notified Bodies Target Audience Notified Bodies Products Concerned MD, IVD Regulatory reference MDR (EU) 2017/745 Annex VII IVDR (EU) 2017/746 Annex VII Documents mentioned NBOG 2017-2 In this document, the MDCG proposes in the form of questions and...
MDCG 2019-5 : Registration of legacy devices in EUDAMED – April 2019
Theme EUDAMED - Legacy Devices Target Audience Manufacturers Products Concerned Legacy Devices (MD, AIMD and IVD) Regulatory reference MDR (EU) 2017/745 Article 120(3) IVDR (EU) 2017/746 Article 110(3) Documents mentioned This guide deals with the case...
MDCG 2019-4 : Timelines for registration of device data elements in EUDAMED – April 2019
Theme EUDAMED Target Audience Manufacturers Products Concerned MD, IVD Regulatory reference MDR (EU) 2017/745 Article 123(3) d) and e) Article 34(3) Article 29(4) Annex VI, part A section 2 Annex VI, part B IVDR (EU) 2017/746 Article 113 (3) a) et f) Article...
MDCG 2019-3 rev 1 : Interpretation of Article 54(2)b – April 2020
Theme Consultation procedure within the framework of clinical evaluation Target Audience Manufacturers, Notified Bodies Products Concerned - Class III implantable MD - Active Class IIb MD intended to deliver/remove a drug to/from the body...
MDCG 2019-2 : Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017 – February 2019
Theme UDI – Combination products Target Audience Manufacturers Products Concerned Combination products : - devices incorporating, as an integral part, a substance which, used separately, would be considered a drug - devices intended for the...
MDCG 2019-1 : MDCG guiding principles for issuing entities rules on Basic UDI-DI – January 2019
Theme Basic UDI-DI Target Audience UDI Issuing entities Products Concerned MD, IVD Regulatory reference MDR (EU) 2017/745 IVDR (EU) 2017/746 Documents mentioned This guide provides some clarification on the format of the basic UDI-DI. The basic UDI-DI...
MDCG 2018-8 : Guidance on Content of the certificates, voluntary certificate transfers – November 2018
Theme Certificates Target audience Notified Bodies (NB) Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Article 58(1) IVDR (EU) 2017/746 Article 53(1) Documents mentioned This guide provides additional information on the content of...
MDCG 2018-7 : Provisional considerations regarding the language issues associated with the UDI database (Annex VI, Part A Section 2 and Part B of the Medical Devices Regulation 2017/745 and the In-Vitro Diagnostic Medical Device Regulation 2017/745 – October 2018
Theme EUDAMED – UDI database Target audience Manufacturers Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Article 28(3) Annex VI part C section 5.10 Article 33(1a) Recitals 43-46 IVDR (EU) 2017/746 Article 25(3) Annex VI part C section 5.10...
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