UK MDR + EU MDR Declaration of Conformity

Hi everyone,

Can you have one declaration in your technical file that declares to conforming to both the EU MDR and the UK MDR? Or do you need two separate declarations?

I think you will need 2 DoCs. The UK DoC needs to reference different information to the EU DoC.

Hi,
apart from the name - 2002/618 what are the other differences? CEN standards can be referenced, the UK has just taken the journal and published it.

Hi,
I would like to know if someone have a template of DofC for UKCA.
Thank you,

Yes I have a template for UK DoC, not sure where it is now as I recently changed jobs. But I got mine by "googling" (other search engines are available). (edit: try googling "UKCA declaration conformity Cass industries")
One technical file, two separate declarations within it, one for EU one for UK (in fact I think there was another one for another country too....)

I have seen combined DoC's that claim to be valid for both EU and UK, so it must be possible if you include both sets of required wording

Thank you very much, I will try to do what you say.
I have another question regarding what you said about the technical file, is the technical file you are talking about based on 93/42/EEC or 2017/745?
When 93/42/EEC was in force, I understand that you could have the two TFs in one, now that 2017/745 is in force, I understand that it could not be possible and we should have a TF based on 93/42/EEC to the UK and one for the EU based on 2017/745, right?
Thanks in advance,

We have one TF per product, based on 2017/745. My understanding is that if it meets these requirements (which are necessary for the EU Rep and sales into Europe), then it also meets (and exceeds) the requirements of 93/42/EEC required for UK marketplace. There should only be one Technical File per product otherwise if nothing else you end up with duplication of a lot of the information, and control/updating documentation becomes a nightmare

Thank you very much, this scenario is crazy for manufacturers, as you said, duplicate documentation could become a nightmare, but this decision is up to each approved body? I mean, we should ask our possible approved body before our documentation is sent, if it is possible that it is in relation to 2017/745?
Thanks,

You send your Approval Body/Notified Body a copy of the file, either printed out or electronic documents; all you need for clarity is a detailed index that makes it clear to them where the master documents actually are, either in a hard-copy file or in a specified electronic folder. When they conduct their assessment they should do random checks to make sure that all is in accordance with what has been stated

I mean, if to avoid problems, we have to previously clarify to the approved body that the document that we are going to send is going to be the version aligned with 2017/745 and not that of 93/42/EEC, since although its requirements are the same or stricter, is not the applicable legislation in the UK.
Thank you @ChrisM