23 Nov 2020 | MDCG
Theme Software and apps qualification and classification Target Audience Manufacturers Products Concerned MD/IVD Software and apps Regulatory reference MDR (EU) 2017/745 and IVDR (EU) 2017/746 Annex VIII Documents mentioned IMDRF/SaMD WG/N12FINAL:2014 :...
23 Nov 2020 | MDCG
Theme Transitional provisions Target Audience Manufacturers, Notified Bodies Products Concerned MD,AIMD Regulatory reference MDR (EU) 2017/745 Article 120 Documents mentioned CAMD FAQ – MDR Transitional provisions This guide addresses article 120 of the MD Regulation,...
23 Nov 2020 | MDCG
Theme Summary of Safety and Clinical Performance (SSCP) Target Audience Manufacturers, Notified Bodies Products Concerned Implantable and Class III Devices Products listed in Annex 16 eligible Regulatory reference MDR (EU) 2017/745 Article 32 Documents mentioned EN...
23 Nov 2020 | MDCG
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...
23 Nov 2020 | MDCG
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...
