A Regulatory Headache #
A key cause of regulatory headache is when you hear your conformity assessment body stating that you are not applying the “State of the Art” guidance or standards. But what do they really mean?
Take this example:
A manufacturer is complying with the harmonised standard EN ISO 10993-1:2020 on Biological Evaluation of Medical Devices. Let us imagine that the new ISO 10993-1:2022 has been released but has not yet been harmonised in the EU. The manufacturer continues to use the harmonised 2020 version and ignores the 2022 version. Their Notified Body assesses their biological evaluation documentation and raises a nonconformity stating that the evaluation does not take into account the state of the art. This is especially confusing since one would automatically think that applying the most recent EU harmonised standard is the way to go. What now?
What is State of the Art? #
“State of the art” is a somewhat complex term and is sometimes thrown around loosely. It is not a legally defined concept either, so definitions you may come across outside legislation are usually non-binding. I remember when state of the art meant cutting edge technology (and a quick Google search verifies that it’s still the case). Alas, in the world of medical device regulation we usually come across State of the Art, or SOTA, being used for different purposes. The EU Medical Device Coordination Group (MDCG) seems to agree with this in their insightful MDCG 2021-5 guidance document on “standardisation for medical devices” (it is certainly worth a read).
The State of the Art your assessors are talking about should not be confused with the generally acknowledged state of the art in medicine related to your medical device type. That is an altogether different story which we will cover in a separate article.
The SOTA with respect to applicable legislation, guidance, standards, or other documents should be understood as the latest technical requirements which are relevant and applicable to your device. Referring back to our example, upon its release, the updated standard became the SOTA, and should certainly be considered.
Although we do disagree with raising a nonconformity in such a case, manufacturers should always be up to date in terms of applicable standards and guidance related to their devices. Not only will it give them an edge on regulatory conformity, but it may also lead to safer devices (and easier assessments!).
So what are you expected to do? #
In our experience with such nonconformities, you are expected to adopt a process of performing a gap analysis against the new standard or guidance applicable to your product. We suggest recording this assessment which highlights any deficiencies in your device or documentation. Whilst guidance and international standards may not be legally-binding, and you are not required to actually comply with these, we do suggest you record a gap analysis activity to show conformity assessment bodies that you have looked into and considered the SOTA. If you have identified any gaps, you may then take a risk-based approach to justify whether or not you will comply with the new requirement. Again, it is important to actually record this justification.
It is worth reiterating that the use of standards is voluntary and you should not be penalised for not applying this during your conformity assessment process. The MDCG go on to say:
It is not possible to impose the use of a specific standard in the conformity assessment of a product, not even on the basis of “compliance with the state of the art”: the “state of the art” expressed by standards must be taken into account but it does not mean “compliance” that must be granted with respect to the legal requirements and not to standards.MDCG 2021-5
The exception to this is when the EU Regulations specifically state that the device must comply with harmonised standards e.g. reprocessing (Article 17(5)) and the application of internationally recognised symbols (GSPR23.1(h)).
Whilst the MDCG says “it is not possible to impose”, we have seen cases where a conformity assessment body raised nonconformities which tried to impose non-binding guidance or standards on the manufacturer. Unfortunately, on more than one occasion. So it is then a question of whether you should fight the nonconformity or comply with the guidance / standard. Obviously, this will depend on your position.
All we can suggest is that you are proactive in identifying relevant new guidance and standards. For example, at one point, ISO 14971:2019 was released but had not yet been harmonised. In that event, we would guide our clients to look into the updated ISO standard and even comply with any new requirements, however, they must continue to apply the deviations from the then-current EN ISO 14971:2012 harmonised standard.
A big issue is for standards providing technical requirements such as the EN 60601 series of standards. These may be updated often, and we have had clients concerned that their Notified Body will impose the new versions on them which would require updating the design and performing additional testing; a time-consuming and costly affair. In such cases, we advise that you conduct a gap analysis against the new requirements and justify whether or not you will be applying these new requirements or provide a justifiable timeline for compliance with the new standard.
How can Specculo help? #
Our consultants assist manufacturers in obtaining and maintaining their CE mark for medical devices and IVDs. If you have received an assessment report with findings you cannot quite understand, contact Specculo to help you succeed in your next round. We can help you put together a Corrective Action Plan (CAP), a regulatory strategy, and even amend/improve your existing documentation.
If that sounds interesting, take a look at the following pages for more details and get in touch with us today!