Indele Limited now an MHRA Authorised Representative for Class I medical devices
- Robert Brannan
- Oct 9
- 2 min read
As the UK Government continues its programme of strengthening controls over products placed on the UK market — updating registration systems, clarifying UKCA routes and refining the responsibilities of economic operators. These changes are intended to make the supply chain more transparent and to improve market surveillance for consumer and patient safety.
We are pleased to announce that Indele Limited has now completed registration with the MHRA to act as an Authorised Representative (AR) for Class I medical devices. This step complements our existing UK Authorised Representative and UKCA services and gives non-UK manufacturers a trusted, UK-based legal presence for placing Class I products on the Great Britain market.
Why this matters to manufacturers and importers
Under the evolving UK framework, having a UK-based economic operator (an AR, UK Responsible Person or an importer taking on manufacturer obligations) simplifies interactions with market surveillance authorities and helps ensure documentary traceability when it matters most. For many non-UK manufacturers, appointing an AR avoids having to give full technical files to multiple importers and creates a single, visible point of contact for regulators.
What Indele’s MHRA registration allows us to do
As an MHRA-registered Authorised Representative for Class I devices we can:
Be listed as the UK contact for the represented manufacturer on MHRA systems where appropriate.
Hold and make available technical documentation to the market surveillance authorities in the UK on the manufacturer’s behalf.
Work with manufacturers and importers to support correct device registration, UKCA/label guidance (where applicable), and any follow-up required by the MHRA.
How our service compares with other market offerings
Many established conformity, testing and regulatory houses in the market offer AR / UKRP / market-access services — from global certification bodies to specialist regulatory consultancies. These organisations often bundle AR services with conformity assessment, testing and wider market-access support; manufacturers should choose a partner that matches their sector needs, device risk, and operational footprint.
Practical next steps for manufacturers
If you manufacture Class I devices located outside the UK and you plan to place those devices on the Great Britain market, please consider:
Whether your UK importer can legally and practically assume the manufacturer’s obligations (many choose not to).
Appointing an MHRA-registered UK AR (or UK Responsible Person where appropriate) so device registrations and regulatory contact details are correctly maintained.
Checking that your technical documentation, labelling and declarations are available and up to date should the MHRA request them.
Need help?
If you are not already a cliente and would like Indele to act as your MHRA Authorised Representative for Class I medical devices, or if you need assistance with device registration, UKCA queries, contact our team. We will explain the options and help you choose the simplest, lowest-risk route to the UK market.
For further information regarding this post, visit the UK Government’s website here:
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