Technical documentation for UKCA

GiuliaGe

Starting to get Involved
Good morning to you all!

My name is Giulia and I work as a Regulatory Affairs Specialist in a company that produces active medical devices.

I am asking you for advice on updating the technical documentation to be submitted for ukca marking.
I understand that the update will involve translating the documentation into English, updating the documentation with references to the designated standards and the UK regulation, and updating the labels and declaration of conformity with the relevant marking.

For the medical device we sell, we are considering submitting the technical documentation to a notified body other than our own that is already accredited and available for UK marking.

At this point I am wondering whether the documentation to be submitted should be an update of the current FT with the addition of UK specific labels and DoCs or whether a technical dossier should be re-issued in which references to European regulations are removed and replaced with references to UK law.

If the 'best'/allowed option was the latter, I wondered whether the UK-specific label could also include the CE mark.

On the one hand I can see the disadvantage of having to update/extend the CE certificate every time a change is required to the product intended for sale outside the EU, on the other hand I have the doubt that running two FTs in parallel would require the distinction into two product codes.

Thank You for any advice or sharing experiences

Giulia
 

Ronen E

Problem Solver
Moderator
Hi,

IMO this query highlights a fundamental issue I see with the majority of manufacturers and RA specialists I come across.

The historical "Technical File" (an RA cultural term, not officially defined anywhere in the regulations that I know) was typically manageable, in size and complexity, as an actual, single file (either hard copy or electronic), and thus this practice became common, though it was never actually mandated anywhere. The current MDR "Technical Documentation" (an official term) is much more complex, and for a non-trivial device would also be quite huge. Additionally, the world is moving away from paper-based systems to electronic formats and systems, which make electronic indexes (either static or dynamic) much more natural and actually more efficient than the traditional "file" concept.

I always believed that maintaining a well-designed index, with pointers to the actual, usually preexisting documentation, is more efficient (and just as effective) as maintaining a "file" (or a folder etc.), whether the latter was paper-based or electronic. Now, with the move to the MDR, I think that it's not only a no-brainer, it's almost a necessity. Maintaining the traditional Technical File format just doesn't make practical sense anymore. The problem is that many RA specialists are so used to creating, maintaining and "grooming" their "own" Technical Files, that they have a hard time letting it go, and sufficing with a smart index that is merely a pointer structure to documents created and maintained by others in the org (e.g. R&D/Engineering, Manufacturing, Marketing, Customer Support etc.). Many feel an urge to write up "a narrative" describing the device and including/repeating a lot of information that already exists in other documents. This is totally unnecessary and not required anywhere in the regulations, and thus makes little business sense (or common sense).

I would normally have the MDR CE Technical Documentation as an index, and when it's submitted for review I would submit all (or the big majority of) the referenced documents with it, in a well-arranged file structure. Of course, taking this approach requires the index to be very well thought through and its references to be pin-pointed (sometimes to the level of a single paragraph, chart or figure etc., in an existing document).

Any other technical documentation submission (e.g. UKCA) could be managed in a similar manner, completely detached. An alternative approach of creating a document highlighting only the points of difference can be taken (maybe less work initially), but it seems to me less "natural" and I wouldn't recommend it because it would result in coupling and require review of all coupled compilations every time the base one is updated.

Cheers,
Ronen
 

ChrisM

Quite Involved in Discussions
At the moment, UKCA marking for medical devices "only" requires compliance with the older EU MDD 93/42/EC, not MDR 2017/745. So as long as you have CE marking and a Technical File meeting the requirements of MDR you should be OK so long as (1) you include reference to the relevant UK Standards in the TF - maybe stating that they are equivalent to/"conjoined" with any applicable ISO/EN Standards used, and (2) your UKCA Declaration of Conformity states the relevant UK Standards (e.g. BS) in place of ISO/IEC/EN..... again these may be "conjoined" or double/triple identified, e.g. BS EN ISO, just be sure to include the "BS" part. There are one or two other "niceties" such as the PRRC being called something like the "Responsible Person" but in general terms if you already have CE marking in place, UKCA marking should be straightforward especially if you have CB Test Certificates/reports
 

Mike Towers

Involved In Discussions
Hello everyone,
We are in the same situation as @GiuliaGe, we have applied for the UKCA mark and would like to know what documentation we need to work on to send to our UK approved body.
We have the TF regarding 93/42/CEE and the updated Technical Documentation regarding 2017/745/EU.
On the one hand, 93/42/EEC is the legislation that applies for the UKCA mark, on the other hand, 2017/745/EU is more up-to-date and more complete, but has some sections than 93/42/EEC are not included, as well as documents such as the PSUR, the GSPR check list instead of the ER, the clinical evaluation in case you want to follow the equivalence approach is much stricter...
So which of them should be modified? What would be the aspects that should be modified on the chosen documentation?

Thank you
 
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