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Theme EUDAMED Target Audience Actors other than manufacturers, authorised representatives, and importers Products concerned MD and IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 MDCG 2019-5 MDCG 2021-3   This document provides information on the...

Theme European Medical Device Nomenclature (EMDN) Target Audience All actors   Products concerned MD and IVD Documents mentioned MDR (EU) 2017/745 Article 26 IVDR (EU) 2017/746 Article 23   This MDCG provides details on the nature, structure and implementation of...

Theme Implant card Target Audience Manufacturers Products concerned Implantable Medical Device Documents mentioned MDR (EU) 2017/746 Article 18 MDCG 2019-8   This document provides a non-exhaustive list of implantable medical "device types" to assist...

Theme UDI Target Audience Manufacturer   Products concerned MD (contact lenses, spectacles frames, spectacles lenses and ready readers) Documents mentioned MDR (EU) 2017/745 Chapter III Annex VI MDCG 2020-18   This position paper is intended to provide further...

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...

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...

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...