Essentials of European Medical Device Regulatory Affairs - June 2020

Combination products regulated as medicines (Article 117)

– Actionof themedicinal substance isprincipal (notancillary) – Devices foradministration -single integralproductnon reusable (prefilledsyringe)

Marketing Authorisation (MA) is required

•

• Device partmust complywith the relevant GSPRS • MAapplication must include: – CEcertificateand /orDeclarationof conformity OR –

NotifiedBodyopinion ifnotCEmarkedand ifaCEcertificatewouldbe required

Requirements apply from May2021

• •

European Medicines Agency Guidance: -1st EMAguidance issued February 2019 https://www.ema.europa.eu/en/news/first-guidance-new-rules-certain-medical-devices -Draft guideline -quality requirements fordrug-device combinations3 June 2019 https://www.ema.europa.eu/en/quality-requirements-drug-device-combinations

TheOrganisation for Professionals in Regulatory Affairs

124

Annex I

General safety and performance requirements

Article 5 “A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose.” • Similar to the MDD Essential Requirements • Increase in number from 13 to 23 • Stronger emphasis on risk management and life-cycle • Active devices and software • Labelling requirements significantly expanded

TheOrganisation for Professionals in Regulatory Affairs

GSPRs General Safety and Performance Requirements Chapter I

TheOrganisation for Professionals in Regulatory Affairs

42