Technical Documentation for Medical Devices

Regulatory Framework and Documentation Requirements

• Understanding the MDR regulatory landscape
• Context for the technical documentation under Article 52 (conformity assessment procedures)
• Key differences between MDR and the former MDD 93/42/EEC

Structure and Content of Technical Documentation

• Building a complete and compliant documentation structure
• Interpreting Annex I, II, and III requirements
• Applying STED (Summary Technical Documentation) principles
• Managing documentation for individual devices and product families

New and Updated MDR Requirements

• Overview of new obligations introduced by the MDR
• Higher expectations for evidence, consistency, and traceability
• Addressing “state of the art” requirements and harmonized standards

Maintaining and Updating Technical Documentation

• Approaches for documentation lifecycle management
• Ensuring continuous compliance with evolving requirements
• Integrating PMS, PMCF, and risk management updates effectively

Core Elements of Technical Documentation

• General Safety and Performance Requirements (GSPRs)
• Risk management documentation aligned with ISO 14971
• Clinical evaluation and supporting evidence
• Usability engineering documentation
• Product Verification and Validation
• Integration of Post Market Surveillance outputs

Practical Examples and Implementation Guidance

• Real world examples of normative and regulatory expectations
• Structuring device specific evidence and supporting data
• Strategies for transitioning from MDD to MDR documentation
• Common challenges—and methods to avoid or address them

International Considerations

• Understanding how MDR documentation aligns with global markets
• Implications for international submissions and regulatory harmonization

• Medical device manufacturers (also outside the EU)
• Technical writers involved in regulatory documentation
• Regulatory Affairs Managers
• Quality Managers
• R&D personnel
• Consultants and service providers
• Suppliers contributing to documentation processes

Why You Should Attend

This seminar is designed for professionals seeking a clear and practical overview of MDR technical documentation requirements. Participants gain the skills to structure documentation effectively, maintain it throughout the device lifecycle, and prepare audit ready evidence packages that meet the expectations of authorities and Notified Bodies. The seminar combines regulatory interpretation with hands on examples, enabling organizations to build robust, consistent, and compliant documentation systems.