John Richard Holborow, Global Head of Clinical Compliance, as he elaborates on BSI's understanding of the occasions when it is appropriate that no clinical data is required for clinical evaluation.
Key Lessons and Takeaway
Topics covered in this presentation:
- The MDR requirements around Article 61 (10)
- What data can be used to support Article 61 (10)?
- Examples of devices suitable for Article 61 (10)
- Considerations for the CER
- Article 7 - Claims
Richard Holborow, Head of Clinical Compliance