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Does the EU IVDR talk about specifics of complaint handling? I looked though it and couldn't find something specific. Is there a guidance that needs to be followed or being ISO 13485 compliant on clause 8.2.2 satisfy the requirements?

Thanks!

Neither to EU-IVDR nor the EU-MDR discuss complaint handling. It is EN ISO 13485:2016/A11:2021.

Your QMS should determine whether a complaint is an incident. If so, that triggers the EU-IVDR or EU-MDR process.<o:p></o:p>

Does the EU IVDR talk about specifics of complaint handling? I looked though it and couldn't find something specific. Is there a guidance that needs to be followed or being ISO 13485 compliant on clause 8.2.2 satisfy the requirements?

Thanks!

Since EN ISO 13485:2016/A11:2021 is not mandated by the EU MDR and IVDR, then both regulations contain various independent clauses demanding a complaint handling system.  Further explanation is given below.

Remember that the receipt and processing of complaints is generally understood to be a form of "reactive" post-market surveillance (PMS).  The IVDR and MDR implement this primarily by way of their PMS Annexes III.1(a) fifth indent (collection and utilization of complaints) and (b) fourth indent (effective and appropriate methods and tools to investigate complaints).  These are driven by the EU IVDR's/MDR's quality management system requirements in Article 10(9), third paragraph, indents (i) & (j).

Multiple other complaint handling provisions of the IVDR and MDR feed the aforesaid legislative complaint handling obligation.  For example, the provisions for authorized representatives, importers, and distributors to forward complaints to the manufacturer so that the manufacturer can investigate the complaints.  Competent authorities are also commissioned by the IVDR and MDR to assure proper handling of complaints.

All this said, if a manufacturer either officially or unofficially applies the EN ISO 13485:2016/A11:2021 clause 8.2.2 provisions for icomplaint handling, then that will certainly be sufficient to fulfill the IVDR/MDR's complaint handling requirements.  This is in particular because, for example, EN ISO 13485:2016/A11:2021 is harmonized for the MDR.

Neither to EU-IVDR nor the EU-MDR discuss complaint handling. It is EN ISO 13485:2016/A11:2021.

Your QMS should determine whether a complaint is an incident. If so, that triggers the EU-IVDR or EU-MDR process.<o:p></o:p>

Does the EU IVDR talk about specifics of complaint handling? I looked though it and couldn't find something specific. Is there a guidance that needs to be followed or being ISO 13485 compliant on clause 8.2.2 satisfy the requirements?

Thanks!

Does the EU IVDR talk about specifics of complaint handling? I looked though it and couldn't find something specific. Is there a guidance that needs to be followed or being ISO 13485 compliant on clause 8.2.2 satisfy the requirements?

Thanks!

 Hi,

ISO 13485:2016 dictates quality process for complaints- complaint handling procedure, IVDR helps with reportability evaluation, what has to be reported, how to report and who has to report and when. 

Does the EU IVDR talk about specifics of complaint handling? I looked though it and couldn't find something specific. Is there a guidance that needs to be followed or being ISO 13485 compliant on clause 8.2.2 satisfy the requirements?

Thanks!