Section J — Where demonstration of conformity based on clinical data is not deemed appropriate (Article 61(10))
Source: MDCG-2020-01.pdf pages 29-30 (document: MDCG 2020-13)
Section J: Where demonstration of conformity based on clinical data is not deemed appropriate (Article 61(10))
Has the manufacturer claimed that the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate in accordance with Article 61(10)?
State Yes / No
Nota bene: A clinical evaluation is still required and the above information and evidence-based justification shall be presented in the clinical evaluation report.
Has the manufacturer provided a justification for reliance upon Article 61(10)?
State Yes / No
If yes, describe the evidence which the manufacturer is relying on, with respect to:
- Performance evaluation
- Bench testing
- Pre-clinical evaluation
Consider:
- Has any available clinical data for the device or an equivalent device been searched for and/or identified by the manufacturer?
If yes — was the identified clinical data integrated in the clinical evaluation. This should include an evaluation of clinical data identified from the literature, and an appraisal of their relevance to the device under evaluation.
- Is clinical data available for similar devices, does this provide information with relevant to the safety and performance of the device under evaluation?
Has the manufacturer conducted an appropriate search of scientific literature? If clinical data for similar devices is available — this should be included in the CER and evaluated and may be of particular relevance to post-market surveillance / PMCF planning.
- The results of the manufacturer's risk management
Are the results of the manufacturer's risk management supportive of the use of non-clinical testing methods?
- Consideration of the specifics of the interaction between the device and the human body
Is the device under assessment part of a system or stand-alone? Is there sufficient information regarding this interaction available from sources other than clinical data?
- The clinical performance intended
What is the intended performance? Is it reasonable to rely upon non-clinical data for the proposed intended performance?
- The claims of the manufacturer
The manufacturer should not make any claims which are not supported by clinical data.
Overall conclusion
Non-compliances identified and resolved for this section may be briefly described in this box
The justification of the manufacturer for reliance upon Article 61(10) is:
- Compliant with the applicable requirements of the MDR:
Include any relevant comments
- Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: