23 Nov 2020 | MDCG
Theme Cybersecurity Target Audience Manufacturer Products Concerned MD that include programmable electronic systems and software that are MD in their own right Regulatory reference MDR (EU) 2017/745 Annex I IVDR (EU) 2017/746 Annex I Documents mentioned...
23 Nov 2020 | MDCG
Theme Marketing Target Audience Manufacturers, Person designated in article 16(1) of the MDR Products Concerned Class I MD Regulatory reference MDR (EU) 2017/745 Article 16(1) Documents mentioned This document provides a summary of the regulatory obligations...
23 Nov 2020 | MDCG
Theme Designation code of Notified Bodies Target Audience Notified Bodies, Designating authorities, Manufacturers Products Concerned MD Regulatory reference Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding...
23 Nov 2020 | MDCG
Theme Conformity Assessment of the Technical Documentation : sampling Target Audience Manufacturers, Notified Bodies Products Concerned Classes IIa and IIb non implantable MD Classes B and C IVD Regulatory reference MDR (EU) 2017/745 Article 52(4) et 52(6) Annex IX...
23 Nov 2020 | MDCG
Theme Designation of Notified Bodies Target Audience Notified Bodies and Conformity Assessment Bodies, Designating authority Products Concerned MD, IVD Regulatory reference MDR (EU) 2017/745 and IVDR (EU) 2017/746 Documents mentioned NBOG 2017-3 NBOG...
