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  • 1.  UKCA and MDR submission for a non-legacy device

    This message was posted by a user wishing to remain anonymous
    Posted 09-Jun-2023 08:15
    This message was posted by a user wishing to remain anonymous

    Morning,

    We are creating the Technical File/ Documentation for a Class III Medical Device and targeting both UKCA and MDR Conformity Assessment. It's a new product, meaning there is no legacy device approved per the MDD.

    Currently, the strategy is to compile a single Tech File for both conformity assessments (UKCA and MDR). The Technical File is being compiled based on MDR recommendations (Annex II and Annex III).  As part of the Tech File, we are listing the classification rules per MDD and MDR. However my question is regarding the GSPR (MDR) and ER (UK MDR 2002/ MDD). Do we need to create both GSPR and ER checklists as part of the Tech File? Can we consider the GSPR as well for the UKCA?.. combining both GSPR and ER in a single checklist looks not straight forward

    Happy to learn from your experience, if any of the readers did face similar scenario and the strategy considered. 

    For info BSI is our NB and we did not discuss the topic with the NB yet.

    BR and thx in advance

    ik



  • 2.  RE: UKCA and MDR submission for a non-legacy device

    Posted 10-Jun-2023 01:17

    In the end, a tech file is needed to convince a reviewer that the device meets the relevant requirements. If the reviewer has a problem navigating the documentation, this can become a problem for the manufacturer. Therefore, you should start with the reviewer in mind when creating your technical documentation.

    In general, if you can demonstrate compliance to the MDR, you will probably also be able to use the same data to demonstrate compliance to the MDD. However, you still need to take some items into consideration, and the difference between Essential Requirements and General Safety and Perfomance Requirements, is one of them. The good news is, that you can use the same evidence for both. My suggestion would be to leave the position of a single tech file. It will probable be easier to keep a clear and consistent file if you would create two separate files. Within these files, you can refer to the same reports (e.g. biocompatibilty evaluation). Especially for a Class III device, you don't want a reviewer having to understand that some parts may not be (fully) relevant. 

    Current UKCA requirements are based on the Directives, but you need to carefully analyze the current state of the UK Medical Devices Regulations 2002, because there have been amendments. These amendments have been added to the legislation, so you have to read through amendments to amendments. There are consolidated versions available, but they come with huge disclaimers that they should not be seen as the official version. The good news is, that most MHRA staff uses the same consolidated version of their legislation, but still... Good luck with that!



    ------------------------------
    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
    ------------------------------

    Original Message


  • 3.  RE: UKCA and MDR submission for a non-legacy device

    Posted 11-Jun-2023 13:31

    Hello Anon,

    You should be able to only have one single Technical Documentation file for both regulations.  Though as you indicate, this needs to be confirmed with your Notified Body/Approving Body as to their approach - I have heard from others BSI does accept one file for both.  In fact, at the recent RAPS Euro Convergence one of the approaches a Notified Bod/Approving Body stated for CE Mark and UKCA is to have a "combined" submission which would ease the process - thus a combined submission would have one Technical Documentation file.  There are some instances where you would need to creatively make a single document or indeed have two documents because the Essential Requirements and General Safety and Performance Requirements are dis-similar.  However, it could be combined in some way, though I personally might recommend only having two documents and then in the single Technical Documentation file reference each of them (they should each have their own document identification).  If this is a legacy device, it should be fairly easy because there should already be an Essential Requirements file. 



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 4.  RE: UKCA and MDR submission for a non-legacy device

    Posted 12-Jun-2023 01:32

    Each Technical File Reviewer has a checklist that they need to follow to evaluate the submitted Technical File. Consequently, since the regulatory requirements for obtaining the UKCA is different to that of the EU CE, specifically in terms of Annex I for EU CE General Safety and Performance Requirements (GSPR) vs UKCA ER (Essential Requirements), I would not consolidate both lists.

    Of course, verification and validation reports and other materials will be common to both submitted Technical Files. 

    Hopefully with the efforts to harmonise regulatory requirements i.e. by the IMDRF, there will be only one list to submit in the future for several countries. 

    Best Regards,

    Stephanie



    ------------------------------
    Stephanie Grassmann
    Founder & Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
    ------------------------------

    Original Message


  • 5.  RE: UKCA and MDR submission for a non-legacy device

    Posted 12-Jun-2023 05:25

    Hi there:

    With a simple medical device, where there is little change between MDD and MDR, this is possible ... but even in this case you end up repeating a diatribe of regulations in all documents "(EU) 2017/745; SI 2002 No 618 as amended .... supplemental UK M&MDA new European Regulations and Decisions .... MDCGs and MEDDEVs and different versions of standards ... and on and on etc usw. Then of course your labeling may be different - photographs of the product may be different .... and finally changes from EU-NB and UK-AB will need to be applied and good luck on getting one to accept the others requirement.

    On a class III product:

    1. I agree with Richard - it should be "possible"
    2. I agree with Ronald - one file will only serve to confuse and extend the review
    3. I agree with Stephanie - the reviewer will run to a checklist, make it easy to approve by giving the information they need (structured in the way they want) and not risk confusion with "alternates" or unnecessary items, and finally,
    4. MHRA have a programme of regulation development and I expect the differences to grow in future years. Testing to the standards may be the same, but how you interpret the results as in meeting GSPRs or ERs will likely be different

    Only in exceptional circumstances would I recommend a single file ... and that depends on getting agreement between your UK-AB and EU-NB on review and handling future changes (series or parallel submissions  of changes).

    The policy of a single submission is fine in theory, but in practice you will live to regret it .... but, it will provide plenty of RA work, so it is not bad for consultant's like me!

    Whatever you do, Good Luck!



    ------------------------------
    Neil Armstrong FRAPS
    MeddiQuest
    Peterborough UK
    Waterford Ireland
    ------------------------------

    Original Message


  • 6.  RE: UKCA and MDR submission for a non-legacy device

    This message was posted by a user wishing to remain anonymous
    Posted 12-Jun-2023 08:32
    This message was posted by a user wishing to remain anonymous

    Hello Anon

    Yes, to be efficient it seems reasonable to keep just one content repository up to date, but it's usually not practical to publish automatically from a repository without special tools.

    For EU and UK and AU and MY and everywhere else you take the device, you'll have different reviewers, each expecting to see what they're used to seeing. It's to your advantage to make their review process simple and straightforward, so they find easily what they need to see and aren't distracted by anything extra.

    That means you'll normally need to produce and maintain separate documentation sets for each jurisdiction, containing a lot of the same information in each, but formatted differently.


    Original Message


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