Detailed Agenda of the Session:
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 It’s Treated from a Regulatory Perspective
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
Relationship to CE Marking
ISO-13485 (Manufacturing) & ISO-14155 (Clinical Investigation & Evaluation) Overview, Conformity, Auditing and Harmonization to International Standards
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
When and How to Influence Regulators
Do's and Don'ts of Regulatory Involvement
NEW EU Medical Device Regulation
Impending Changes expected in the two NEW Device Regulations
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 It’s Treated from a Regulatory Perspective
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
Relationship to CE Marking
ISO-13485 (Manufacturing) & ISO-14155 (Clinical Investigation & Evaluation) Overview, Conformity, Auditing and Harmonization to International Standards
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
When and How to Influence Regulators
Do's and Don'ts of Regulatory Involvement
NEW EU Medical Device Regulation
Impending Changes expected in the two NEW Device Regulations
