Meaning of Article 61 (10) of the MDR 2017/745

Simona sak

Starting to get Involved
#1
Hi to all,
Please we have a class IIb Medical Device intended for the disinfection of invasive devices. The demonstration of conformity of this product with the GSPR is not based on clinical data. Non-clinical testings done according to international standards used are sufficient to confirm the clinical performance of the device.

According to article 61 (paragraph 10) they said that "
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 preclinical evaluation, to be adequate."

So do you think please that there is no need for a Clinical Evaluation Report and also PMCF for this product. Only, an adequate justification will be given based on the results of risk management and on consideration of the specifics on the interaction between device and human body, the clinical performance intended and the claims of the manufacturer.
Thansk in advance and bet regards
Simona
 
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mboynton

Starting to get Involved
#2
Hi Simona, I can see why no new clinical data would be needed for the device type you describe. But I would recommend that you take the adequate justification you describe and use that as the basis for a clinical evaluation report w/o clinical data, rather than not create a clinical evaluation report at all. Please see MDCG 2020-13, section J. In particular, the MDCG guidance discusses how to deal with clinical information on potentially similar/ equivalent devices in this context.

https://ec.europa.eu/health/system/files/2020-07/md_2020-13-cea-report-template_en_0.pdf

For PMCF, I would recommend viewing that as two separate justifications - whether any specific PMCF methods are needed (Annex XIV, Part B, 6.2(b)) aka a PMCF study; and whether a PMCF plan is needed. PMCF plan could include more than just PMCF study, per Annex XIV, Part B, 6.2(a) general methods. These PMCF general methods may be accomplished "for free" through activities you already have in your PMS plan, if you mine the PMS data for any clinical data generated.
 
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