Prior to marketing a medical device, manufacturers must comply with applicable conformity assessment procedures set out in Annexes IX to XI of (EU) 2017/745 Medical Devices Regulation (MDR). Medical Devices Notified Bodies like BSI and manufacturers have a shared interest in accelerating the review of Technical Documentation (Summary of Technical Documentation, dossier, technical file, renewal application, etc.) to reduce certification issuance time.
Download this whitepaper to learn:
- Quality management system application requirements
- Technical documentation review submission contents
- Suggested documentation format
- Submission process
- Additional technical documentation considerations