Harmonised Standards for MDR? CEN/CENELEC say “Non”
Back in November 2019, looking at the virtual break down in harmonisation of standards to the European Directives and the belated request from the Commission for harmonisation to MDR of a handful of (largely outdated) standards, we asked: “Are Harmonised Standards facing irrelevance?” CEN and the Commission have since played catch up, announcing in March 2020 a bunch of updates to latest standards (including things like ISO 10993-1:2018 and ISO 13485:2016). See the full list here.
The deadline for response was 17 June, and it appears that just one day before the deadline (according to a post shared on LinkedIn by an EC official), on 16 June, CEN/CENELEC rejected the Commission request and sent it all back to the drawing board
We now have a brewing argument between the Commission – which seeks greater influence over the content of standards and their alignment with regulations, and the standards bodies, who are relying on experts to define a current State of the Art in drafting the standards.
The consequence is that we will likely have few or no harmonised standards when the MDR reaches the end of the recently delayed transition, and when the IVDR is implemented in 2022.
So, what should a manufacturer do? The practical answer appears to be to revert to using the latest version of the international standard (mostly an ISO version) and to justify why that document represents the current state of the art. And do that for every standard you utilise.
Yes, that’s cumbersome, yes it adds more work, but at least it’s a way forwards and some Notified Bodies are already pushing this approach. It’s going to be essential to check with your Notified Body what their approach is – and if they accept such “State of the Art” arguments. Especially do this before commissioning any testing. You want to make sure you test to the right version.
For more details on the harmonisation process and the current state of play take a look at our November 2019 blog. Meanwhile, be prepared to have to justify your use of every technical standard and talk to your Notified Body early about how they will review standards and testing – before you retain a laboratory.
If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)
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