27 May 2021 | MDCG
Theme Clinical investigations Target Audience Sponsors Products concerned MD Documents mentioned MDR (EU) 2017/745 MDCG 2021-1 Rev.1 This guide lists all the useful documentation for clinical investigation requests in accordance with the MDR (EU) 2017/745 and...
19 May 2021 | MDCG
Theme COVID-19 Tests Target Audience Manufacturers, Authorised representatives Products concerned IVD Documents mentioned IVDR (EU) 2017/746 MEDDEV 2.12-1 This document is intended for manufacturers and authorised representatives of in vitro diagnostic medical...
10 May 2021 | MDCG
Theme Clinical investigation Target Audience Sponsors (recital 49) Products concerned MD Documents mentioned MDR (EU) 2017/746 Chapter VI Directive 90/385/EEC Directive 93/42/EEC ISO 14155 :2020 Aimed primarily at sponsors of clinical investigations, MDCG...
10 May 2021 | MDCG
Theme Harmonised standard, conformity assessment Target Audience Manufacturers, Subcontractors, Notified Bodies Products concerned MD and IVDMD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 Directive 90/385/EEC Directive 93/42/EEC Directive 98/79/EC...
10 May 2021 | MDCG
Theme Transitional provisions – Conformity Assessment – EURL Target Audience Manufacturers, Notified Bodies Products concerned Class D IVD Documents mentioned IVDR (EU) 2017/746 This guide in the form of questions and answers provides indications on how...
