Module 18 2021

06/02/2021

Acknowledgements

Many thanks to the national IVD Manufacturers Associations and to MedTech Europe in Brussels, representatives of the national Medical Device Authorities, Notified Bodies and the European Commission for the many helpful discussions over the past years

Volker Franzen / Maranna Sweeney

Thank you! Questions ??

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NANDO List of Notified Bodies for Conformity Assessment https://ec.europa.eu/growth/tools- databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

Medical Device Coordination Group (MDCG) http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=3565

Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR: https://ec.europa.eu/docsroom/documents/37581

MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under the Regulation (EU) 2017/46 https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_guidance_classifi cation_ivd-md_en.pdf MedTech Europe eBooklet about the ‘Clinical Evidence Concept’ under the Regulation 2017/746/EU on In-vitro Diagnostic Medical Devices https://www.medtecheurope.org/wp-content/uploads/2020/05/MedTech-Europe-Clinical-Evidence- Requirements-for-CE-certification-eBook-2020.pdf

References Part I

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