Market access
UK Rep and EU Rep under one roof
Before Brexit, one Authorised Representative in the EU covered you for the whole bloc, the UK included. That is gone. To sell in both Great Britain and the EU you now need two distinct roles filled: a UK Responsible Person for the MHRA, and an EU Authorised Representative for the EU.
Most foreign manufacturers end up with two separate firms doing this. It works, until it does not.
Why two contracts quietly cost you
- Two versions of the truth. Your technical file, your registrations and your vigilance records now live in two places, maintained by two teams who do not talk to each other.
- Gaps at the seams. A change that affects both markets has to be picked up, twice, by people with no shared view. Things fall down the gap.
- Slower when it matters. A field safety action or a Notified Body question needs both representatives aligned. Two firms means two timelines.
The case for one roof
We hold both roles. UK Responsible Person from Newcastle, EU Authorised Representative from Cork. One contract, one file, one team that sees your whole position across both markets.
That means a change is handled once. A registration is consistent across both systems. And when something urgent lands, you are talking to people who already have the full picture, not briefing two firms from scratch.
What to check on your own setup
- Do you actually have both roles filled, on paper, today?
- Is the same technical file feeding both, or have they drifted apart?
- If a deadline or an incident hit tomorrow, who coordinates the two?
If those answers are not clean, that is worth a conversation. It is exactly the gap we were built to close.
Want this turned into a plan for your file?
Book a free consultation, or start with a fixed fee Gap Assessment.
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