Regulatory Open Forum

Hi all,

I know that there have been preior discussions on state of the art standards, but couldn't find something that that would address my problem.

We are class I under the current UK MDR and are not planning on going into in EU anytime soon. Since the UK Designated Standard list has not been updated since 2021, and our consultants / ISO13485 auditors have different opinions, I thought I'd raise the question here. Should we be compliant and state compliance with the SOA (harmonised) standards, or with the versions included in the list of the designated standards? Should we follow ISO 13485:2016 or should we include EN ISO 13485:2016/A11:2021? Even if the amndment is not applicable to us?

Thanks in advance for your input!

The UK and Europe used to be the same, but have now split. The history before the split is not relevant (assuming you are not in Northern Ireland). Think of them as two regulatory regions. As a model, consider the US and the UK. They split, but we would not expect the US FDA to accept UK regulations because of the historical basis. In other words, consider each regulatory region as independent of the others. Since your company is not planning to market in the EU, you can ignore that regulatory region unless specified in the UK regulations.

Harmonization in the EU and designation in the UK does not mean state of the art for standards. You should use the current version. For example, if ISO revises a standard that is on the designated list, then the ISO version becomes SOA, not the version on the designated list.

Specifically, you should follow ISO 13485:2016  and not EN ISO 13485:2016/A11:2021 since you will not implement the EU-MDR.

Hi all,

I know that there have been preior discussions on state of the art standards, but couldn't find something that that would address my problem.

We are class I under the current UK MDR and are not planning on going into in EU anytime soon. Since the UK Designated Standard list has not been updated since 2021, and our consultants / ISO13485 auditors have different opinions, I thought I'd raise the question here. Should we be compliant and state compliance with the SOA (harmonised) standards, or with the versions included in the list of the designated standards? Should we follow ISO 13485:2016 or should we include EN ISO 13485:2016/A11:2021? Even if the amndment is not applicable to us?

Thanks in advance for your input!

Hi all,

I know that there have been preior discussions on state of the art standards, but couldn't find something that that would address my problem.

We are class I under the current UK MDR and are not planning on going into in EU anytime soon. Since the UK Designated Standard list has not been updated since 2021, and our consultants / ISO13485 auditors have different opinions, I thought I'd raise the question here. Should we be compliant and state compliance with the SOA (harmonised) standards, or with the versions included in the list of the designated standards? Should we follow ISO 13485:2016 or should we include EN ISO 13485:2016/A11:2021? Even if the amndment is not applicable to us?

Thanks in advance for your input!

Standards are not mandatory. However, notified bodies and UK approved bodies will expect to see references to certain standards. Standards are continuously updated. Some time later those updated standards may become harmonized. When referring to a standard that is also harmonized, a manufacturer has two options. They can refer to the harmonized standard and the certification body must accept that. Or they refer to the updated version, stating that they consider that more state of the art then the harmonized version. They have to create a justification listing the exact requirements that are met by that standard, but often it is possible to more or less copy that from the harmonized standard. In my experience, certification bodies accept this approach. 

Especially in cases of a significant update in a standard, it can be recommended to go for the latest version. This may prevent having to create additional evidence later. 

Hi all,

I know that there have been preior discussions on state of the art standards, but couldn't find something that that would address my problem.

We are class I under the current UK MDR and are not planning on going into in EU anytime soon. Since the UK Designated Standard list has not been updated since 2021, and our consultants / ISO13485 auditors have different opinions, I thought I'd raise the question here. Should we be compliant and state compliance with the SOA (harmonised) standards, or with the versions included in the list of the designated standards? Should we follow ISO 13485:2016 or should we include EN ISO 13485:2016/A11:2021? Even if the amndment is not applicable to us?

Thanks in advance for your input!

Hi all,

I know that there have been preior discussions on state of the art standards, but couldn't find something that that would address my problem.

We are class I under the current UK MDR and are not planning on going into in EU anytime soon. Since the UK Designated Standard list has not been updated since 2021, and our consultants / ISO13485 auditors have different opinions, I thought I'd raise the question here. Should we be compliant and state compliance with the SOA (harmonised) standards, or with the versions included in the list of the designated standards? Should we follow ISO 13485:2016 or should we include EN ISO 13485:2016/A11:2021? Even if the amndment is not applicable to us?

Thanks in advance for your input!

The UK MDR 2002 is based upon the EU Directives, so for example Essential Requirement 2 of the MDD still applies, "...taking account of the generally acknowledged state of the art". As Dan has said already, harmonisation and in this case designation for the UK, does not necessarily mean the latest version of the standard. To use the UK designated standards, in several cases (especially for key horizontal standards) you would be using a superseded version of the standard. The approach taken by many EU Notified Bodies is that they would expect to see conformity to the latest version of the standard (because this is considered the state-of-the-art standard for that subject, see MDCG 2021-5) or conformity to the version harmonised against the applicable Directives PLUS some form of gap assessment addressing the differences between the two versions of the standard. All of the UK Approved Bodies are also EU Notified Bodies, so we can expect the same approach.

We know that designation of UK standards for medical devices has stalled and is currently under debate about what lies ahead. My advice would be to apply/implement the latest versions of the applicable standards for your device, but to also consider the content of any of those that are listed on the designated standards list to demonstrate that you are aware of them. Newly published standards, technical reports etc. will not be listed on those designated UK standards lists and those standards should not be ignored in favour of the designated list due to its age and lack of maintenance since 2021. Updated versions of EN standards that the become the harmonised EN version should be considered too as the European Foreword will reflect the current thinking of how to apply the standard in the context of EU regulations, and given that it is quite possible that the new UK framework will be closer to the EU MDR/IVDR than it is currently, being ahead of that change could be beneficial.

Hi all,

I know that there have been preior discussions on state of the art standards, but couldn't find something that that would address my problem.

We are class I under the current UK MDR and are not planning on going into in EU anytime soon. Since the UK Designated Standard list has not been updated since 2021, and our consultants / ISO13485 auditors have different opinions, I thought I'd raise the question here. Should we be compliant and state compliance with the SOA (harmonised) standards, or with the versions included in the list of the designated standards? Should we follow ISO 13485:2016 or should we include EN ISO 13485:2016/A11:2021? Even if the amndment is not applicable to us?

Thanks in advance for your input!