Maintaining compliant technical documentation and ensuring alignment with the General Safety and Performance Requirements (GSPR) are critical to securing regulatory approval, market access and patient safety. This intensive training provides a deep dive into Annex II and III requirements, equipping participants with knowledge and practical tools to manage documentation effectively, transition legacy devices and plan for key MDR deadlines.
Annex II: Set out comprehensive requirements for product technical documentation. Technical Documentation ensures that all essential information about device design, manufacturing, safety, performance, and validation is systematically recorded and maintained. This is crucial for CE marking, conformity assessments, and audit readiness.
Annex III: Complements Annex II by shifting the focus to the post-market phase. Technical Documentation on Post-Market Surveillance extends compliance into the real-world environment, requiring ongoing monitoring, reporting, and corrective action to continuously demonstrate device safety and effectiveness throughout the product lifecycle.
Understanding Annex II and Annex III in depth is vital for regulatory, quality, and technical professionals who are responsible for compiling, reviewing and maintaining documentation. Many regulatory nonconformities and audit findings trace back to incomplete or poorly structured technical files.
Core Topics Covered in the Training:
- Annex II & III Requirements: how they interconnect and how to structure and maintain comprehensive technical documentation for medical devices, including updates required under MDR
- Legacy Device Transition: Strategies to evaluate, update, and transition pre-existing devices to meet MDR expectations while ensuring business continuity
- Deadline Planning & Regulatory Strategy: Proactive approaches for managing timelines, avoiding non-compliance risks, and maintaining market access
- GSPR Essentials (Annex I): How to demonstrate compliance with the GSPR
- Compliance and Risk Management: Integrating risk-based approaches into technical documentation to ensure alignment with both regulatory and clinical expectations.
- Share best practices and common pitfalls from audits and industry experience.
Target Audience: Regulatory Affairs Specialists/Managers, Quality Assurance Managers, Design & Development Engineers, Design & Development Engineers, Clinical Affairs Managers.
Benefit: Participants will gain:
This training is designed for Regulatory Affairs, Quality Assurance, and Product Development professionals seeking hands-on guidance for MDR compliance. Participants will leave equipped with the tools and strategies to confidently prepare technical documentation, navigate legacy device transitions and ensure ongoing market access under MDR.
Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH
Trainer: Is a highly qualified regulatory expert from DQS MED, a leading Notified Body with deep expertise in conformity assessment under EU MDR.
