Essentials of European Medical Device Regulatory Affairs - June 2020

Vigilance

Competent authorities • Assess individual cases • Look for trends and signals • Expect corrective actions • Expect a product to be withdrawn

• Conduct inspections Commission • Setting up an electronic system connected to UDI • Can make changes e.g. reporting timelines and process • Override national actions

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Chapter VIII

Cooperation between member states, medical device coordination group, expert laboratories, expert panels and device registers

Articles 101-108

Medical Device Coordination Group (MDCG), is an expert committee, composed of persons designated by the Member States (MS) based on their role and expertise in the field of medical devices to provide advice to the Commission with the aim of a harmonised implementation of the Regulation.

• Commission provide the logistics • Industry is attending as an observer

Commission needs to create a panel of independent experts for assessment of clinical evaluation

Commission can designate expert laboratories

Commission can publish scientific opinions on clinical evaluations and create registries of similar devices

Scientific advice may attract a fee

TheOrganisation for Professionals in Regulatory Affairs

EU Commission

MDCG will have subgroups

• Post Market Surveillance & Vigilance (PMSV) • International/IMDRF coordination (INT) • Notified body oversight (NBO) • Market Surveillance (MS) • New technologies (NET) and Software • Clinical investigation and evaluation (CIE) • Annex XVI (no medical purposeproducts) • In Vitro Diagnostics (IVD) • Unique Device Identification (UDI) • Standards (STAND) • Borderline and Classification (B and C)

TheOrganisation for Professionals in Regulatory Affairs

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