유럽 체외진단의료기기규정 (EU IVDR) - 요구사항의 이해와 적용

Time

Topic

09.00

Lunch

17.00

Benefits to you, welcome and introductions

Boundaries: Conflicts of interest and expertise

Course aims, structure and objectives

What is an IVD?

EU Single market and the IVDR

·       Journey to the IVD Regulation

·       Advantages of the changes

·       Delegated and implementing acts

·       Structure of the IVDR

Responsibilities

·       Economic operators

·       Who gets an SRN?

·       Person responsible for regulatory compliance

·       Notified bodies

·       Competent authorities

·       Others in supply chain

Placing on the market

·       Putting into service

Harmonized standards and common specifications

CE mark

Risk-based classification

·       Intended users and test

·       Classification of controls

·       Classification dispute

Conformity assessment

·       Routes of conformity

·       Sampling strategy

·       Certificate scopes

·       Certificates issued under Annexes

·       EU reference laboratories

·       Companion diagnostics

Notified bodies and scrutiny

·       Unannounced audits

·       MDCG and regulatory operators

Reflection and feedback

Close of day

Time

Topic

09.00

Lunch

17.00

Welcome to day 2

Case Study business case

GSPRs

• GSPR Trace Matrix
• Risk Management
• EN ISO 14971

Performance evaluation, clinical evidence and post-market performance follow-up

• General requirements for performance studies
• Clinical evidence, performance evaluation, scientific validity and analytical performance
• Performance evaluation plans and reports
• Summary of safety and performance
• Post-market performance follow-up
• Interventional and special clinical studies

Post-market surveillance and vigilance reporting

• Post-market activities and post-market surveillance
• PMS Report and PSUR
• Vigilance reporting
• MEDDEV guidance

End of day 2

Time

Topic

09.00

Lunch

17.00

Welcome to day 3

Case study regulatory strategy

Technical documentation

• Expectations of the IVDR
• Technical file review and Notified Body expectations
• QMS technical documentation

Product claims and labelling

• Claims
• Labelling
• Symbols
• Safety data sheets

EUDAMED and registration

• Annex VI Registration
• Unique Device Identifier (UDI)

Significant changes

Other Directives and Regulations

Case study: Product strategy

Course reflection

End of course