Essentials of European Medical Device Regulatory Affairs

Key Changes

Wider Scope

NotifiedBodies

Clinical Evidence

Pre-market

Post-market Surveillance& Vigilance

Transparency& Traceability

Governance& Oversight

Less equivalence, moredata for high risk devices

Strictdesignation & monitoring criteria

DevicesandEconomic Operators registered centrally

Deviceswithnon- medicalpurpose

Scrutiny for high riskdevices

Central database & Co-ordination

Central Committee:MDCG

PublishSafety & Performance data & outcomeof clinical evaluation (class III & implantable)

Medicaldevices utilisingderivatives of non-viable(or renderednon-viable) tissues or cellsof humanorigin

Joint audits: 3 MemberStates & Commission

Common Specifications

UniqueDevice Identification(UDI)

ExpertPanel,Expert Laboratories

Trend reporting

Responsible person for manufacturer& Authorised Representative

Strengthened positionof NBs & Unannounced audits

Implantcards, SSCP (summaryof safety & clinicalperformance)

Enforcement activities

PMCF

The Organisationfor Professionals inRegulatory Affairs

EUDAMED – MDR Article 33

The Organisationfor Professionals inRegulatory Affairs