8/12/2019 Online Course on Medical Devices EU Directives, Guidance Documents, CE Marking Process and ISO Certification P

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8/12/2019 Online Course on Medical Devices EU Directives, Guidance Documents, CE Marking Process and ISO Certification P

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Detailed 'genda o t$e ession

Definition: Medical Device or Personal Protective Equipment.

Overview of the Global Medical Device Industry

Standard

Active Implanted

In Vitro Diagnostic

Combination Products; Drug or Biologic + Device- Interface with Other Directives and How Its Treated from a RegulatoryPerspective

An Overview of the Medical Device Directives.

Development, aims, implementation and update of the Medical Device Directives

Implication of an EU Directive vs. Regulation

Medical Devices (MDD), Active Implanted Medical Devices (AIMDD), In Vitro Diagnostic Medical Devices (IVDMD),

Combination Products

Update on the additional guidance documents relating to the directives

Essential Requirements

Classification of MD's and Process Implications

Conformity Assessment

Technical File

Relationship to EU Clinical Trial Directive

Guidance Documents.

Medical Device Directive Annexes.

Compliance Requirements by Type

Full Quality Assurance System

Declaration of Conformity

Safety.

Medical Device Vigilance System

Manufacturer's Requirements

GMP

GCP

CE Marking

ISO Certification

Clinical Trials

Labeling

ISO Standard Certification.

Overall process; Management Commitment & Involvement

Role of Notified Bodies

8/12/2019 Online Course on Medical Devices EU Directives, Guidance Documents, CE Marking Process and ISO Certification P

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Relationship to CE Marking

ISO-13485 (Manufacturing) & ISO-14155 (Clinical Investigation & Evaluation) Overview, Conformity, Auditing and

Harmonization to International Standards

ISO-14155 Medical Device Clinical Investigations.

Part I- Clinical Studies

Part II- Clinical Investigations

Linkage to EU Clinical Trial Directive; What Does & Doesn't Apply

Compare & Contrast EU & FDA Procedures and Requirements.

Process Similarities & Differences

Implications for Industry

Company Management

Process Changes

Management Team Effectiveness

Regulatory Approval and Liaison with Regulators.

EU Co-Decision Procedure

Committees, Working Parties Relevant for Medical Devices

When and How to Influence Regulators

Do's and Don'ts of Regulatory Involvement

Individual Company Involvementvs. Trade Association

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