Rincewind
Involved In Discussions
I have written Clinical Evaluations using the literature route and so far they have been accepted by the NB.
My question is regarding very low risk devices where there are no clinical literature can be found because no one is performing a clinical study on a surgery table, a scalpel or a plaster. But you would still need a clinical evaluation.
According to MDR Art. 61, paragraph 10:
Without prejudice to paragraph 4, where the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer. In such a case, the manufacturer shall duly substantiate in the technical documentation referred to in Annex II why it considers a demonstration of conformity with general safety and performance requirements that is based on the results of non-clinical testing methods alone, including performance evaluation, bench testing and pre-clinical evaluation, to be adequate.
I am assuming this paragraph was written for products like the ones I mentioned earlier.
So I am wondering if the reference to used harmonized standards and a positive Risk-Benefit Conclusion would be enough in general in cases like described above and would you still have to structure the CER according to MEDDEV 2.7/1 rev 4 in that case?
Thank you for any input.
My question is regarding very low risk devices where there are no clinical literature can be found because no one is performing a clinical study on a surgery table, a scalpel or a plaster. But you would still need a clinical evaluation.
According to MDR Art. 61, paragraph 10:
Without prejudice to paragraph 4, where the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer. In such a case, the manufacturer shall duly substantiate in the technical documentation referred to in Annex II why it considers a demonstration of conformity with general safety and performance requirements that is based on the results of non-clinical testing methods alone, including performance evaluation, bench testing and pre-clinical evaluation, to be adequate.
I am assuming this paragraph was written for products like the ones I mentioned earlier.
So I am wondering if the reference to used harmonized standards and a positive Risk-Benefit Conclusion would be enough in general in cases like described above and would you still have to structure the CER according to MEDDEV 2.7/1 rev 4 in that case?
Thank you for any input.