Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require?

[SoftwareasaMentalDevice]

Hello All,

I have a client who is currently drafting their UKCA Declaration of Conformity in order to sell their device in the UK market.

Question: Which reference of the standard ISO 13485: 2016 should be stated in the DoC? Is EN ISO 13485:2016/AC:2018 now the new standard that can be claimed if the client holds their EN ISO 13485:2016 certificate from SGS? Assuming the supporting evidence is consistent in which reference of the standard is chosen.

Am I correct in thinking that ".../AC:2018" amendment corrigendum only adds informative annexes and therefore does not modify the technical requirements? And therefore a NB audit would not change the already issued 13485 certificate scope.

Cheers!

 

[dgrainger]

The list for GB designated standards is here: Designated standards: medical devices

It lists two versions:

125​

EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes​

EN ISO 13485:2016/AC:2016​

​

126​

EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes​

EN ISO 13485:2016/AC:2018​

However... in ANNEX II it states that the first of these will be removed by 30/9/21.

 

[SoftwareasaMentalDevice]

The list for GB designated standards is here: Designated standards: medical devices

It lists two versions:

125​

EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes​

EN ISO 13485:2016/AC:2016​

​

126​

EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes​

EN ISO 13485:2016/AC:2018​

However... in ANNEX II it states that the first of these will be removed by 30/9/21.

Thanks for the response, yes I have seen this list but from a DoC perspective what should be written? Are corrigendum references essential or optional text?