QMS under the MDR


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Hello, we market a legacy device class I under the directive and will become class IIA under regulation 2017/745, my question is in relation to the QMS update, is it going to concern only post-marketing surveillance (procedure, plan and PMS report)? And for clinical evaluation, we have a report that was written under the directive, do we need to create a clinical evaluation procedure and update the CER report, however no changes have been made for our medical device software.

thank you again


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Tough question!

You'll have to get a NB to issue a CE mark now, right? And you'll need to demonstrate full design controls compliance, I expect. So if your current QMS doesn't address design controls - and especially software development, you do probably have some updates to make.

With software, IEC 62366 was harmonized under the MDD - not sure if it's yet harmonized under the MDR - but that standard has a method for dealing with Legacy Software that might be helpful. It should allow you to take a risk-based approach to filling in any gaps.

Going to side-step the question about a clinical evaluation other than suggesting you do need to collect clinical data and comply with all postmarket requirements under the MDR for Class IIa.

You should consult with a regulatory expert to ensure you're on the right path.
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