Meeting the requirements of the EU Medical Device Regulation (EU MDR) 2017/745 requires manufacturers to maintain comprehensive technical documentation that demonstrates the safety, performance and conformity of their medical devices throughout the product lifecycle.
This webinar provides a practical overview of the EU MDR technical documentation requirements under Annex II and Annex III, with a focus on the information, evidence and processes manufacturers need to establish and maintain for regulatory compliance and market access.
The webinar will help participants understand how Annex II and Annex III work together across the medical device lifecycle and how robust documentation can support regulatory readiness and ongoing compliance.
What you will learn?
By attending this free webinar, you will:
- Understand the key EU MDR technical documentation requirements under Annex II
- Identify the essential information and evidence required to demonstrate device safety, performance and conformity
- Explore the relationship between risk management, clinical evaluation, verification and validation, and technical documentation
- Understand the key documentation requirements for Post-Market Surveillance under Annex III
- Learn how Annex II and Annex III documentation support compliance throughout the medical device lifecycle
- Gain practical insights from an experienced medical device lead auditor and trainer during the live Q&A
Agenda
- Introduction to EU MDR technical documentation requirements
- Overview of Annex II, Technical Documentation
- Key elements and evidence required under Annex II
- Linking technical documentation with risk management and clinical evaluation
- Overview of Annex III, Post-Market Surveillance documentation
- How Annex II and Annex III requirements work together
- Common documentation challenges and practical considerations
- Summary and key takeaways
- Live Q&A
Who should attend?
This webinar is ideal for professionals involved in medical device regulatory compliance, quality management and product development, including:
- Medical Device Manufacturers
- Regulatory Affairs Professionals
- Quality Assurance and Quality Control Professionals
- Medical Device Quality Managers
- Regulatory Compliance Managers
- Design and Development Professionals
- Risk Management Professionals
- Clinical and Post-Market Surveillance Teams
- Consultants and Auditors
- Professionals responsible for EU MDR compliance and technical documentation
About SGS
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of over 100,000 dedicated professionals. With more than 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and a portfolio of trusted specialized brands, including Applied Technical Services, Brightsight, Bluesign and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN SW).