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.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 10-Jun-2023 01:17
From: Ronald Boumans
Subject: UKCA and MDR submission for a non-legacy device
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!
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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
Original Message:
Sent: 09-Jun-2023 05:46
From: Anonymous Member
Subject: UKCA and MDR submission for a non-legacy device
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