Germany is the largest healthcare market in Europe and, for many UK life-sciences companies, the natural EU beachhead. But since 2021 Great Britain has been a third country to the EU. Your MHRA approval and your UKCA mark stop at the Channel — and the EU footing you now need is exactly the thing Brexit removed. This is the map of the new border.
Since the Brexit transition ended, Great Britain is a third country to the EU, so a UK company entering Germany needs an EU footing it did not need before 2021. For medicines, an MHRA authorisation is not an EU one: you take a separate EU or national marketing authorisation, and your MAH, QPPV and PSMF must sit in the EEA. For devices, a UKCA mark and a UK Responsible Person do nothing in the EU: you need a CE mark from an EU Notified Body plus an EU27 Authorised Representative and a PRRC. Northern Ireland is the exception — it stays EU-aligned for goods under the Windsor Framework. Then both tracks meet the same German wall every entrant meets: a CE mark or authorisation lets you sell, but reimbursement — AMNOG for drugs, DRG/NUB for devices — is a separate project.
UK companies arrive with advantages: English is Germany's business second language, the sectors are deeply integrated, and Germany was an EU home market until recently. That familiarity is exactly what hides the trap.
Before 2021, a UK life-sciences company operated inside the EU system: an EU authorisation covered Germany, a UK-based Authorised Representative or marketing-authorisation holder was an EU one, and product moved without a regulatory border. Brexit ended all of that. Great Britain is now, in EU regulatory terms, no different from the United States or Switzerland — a third country whose approvals and representatives do not carry into the Union.
The commercial closeness is real and worth using. The regulatory closeness is gone. Plan for both truths, because the second is the one that stalls launches.
Brexit did not move the UK further from Germany commercially. It put a hard regulatory border down the middle of the Channel.
This guide is about coming into Germany and the EU. Looking the other way — at the Gulf, Middle East or Africa? Our UK practice, BCA Business, takes UK medtech, diagnostics and pharma into six regulated markets — Saudi Arabia, the UAE, Egypt, Turkiye, Nigeria and South Africa — on the same principle we apply here: a locally licensed representative is a legal precondition, and a UKCA mark on its own counts for nothing.
What you make sets your path. Both now start by rebuilding an EU footing that your UK base can no longer provide — then both end at the same wall: allowed to sell is not the same as paid.
Because Great Britain sits outside the Union, a UK address can no longer carry the legal responsibility EU rules demand. Someone established inside the EEA has to — and that is precisely the role Brexit stripped out of UK entities.
| Requirement | Devices & diagnostics | Medicines |
|---|---|---|
| EU legal standing | A sole EU27 Authorised Representative (MDR/IVDR Art. 11) in the EEA. A UK Responsible Person does not satisfy this. | An EEA-established marketing-authorisation holder carries the authorisation and liability. |
| Responsible person | A PRRC for the manufacturer; the Authorised Rep needs its own PRRC too. | An EU/EEA-based QPPV and PSMF for pharmacovigilance, plus a Qualified Person (QP) for batch release. |
| Conformity / approval | A CE mark from an EU Notified Body. UKCA is for the GB market only. | A fresh EU or national marketing authorisation. An MHRA authorisation is separate. |
| The reflex to drop | A UK approval or mark, and a UK-based rep, once covered the EU. Since 2021 they do not. Rebuild the EU footing deliberately — and remember reimbursement is a separate project again. | |
Whether you appoint an external provider for these roles or stand up your own German entity is a genuine strategic choice. We work through it in local representation in Germany. The footing problem is nearly identical to the one facing US and Swiss companies — Brexit simply moved the UK into the same category.
The trap for UK companies is muscle memory — assuming the pre-2021 world still holds. Four separations matter most.
The UK runs its own approvals since Brexit. A UK marketing authorisation gives you nothing in the EU, and vice versa — two separate systems.
UKCA is the UK mark for the GB market. To sell a device in Germany you need a CE mark from an EU Notified Body — UKCA is not recognised in the EU.
A UK Responsible Person or UK-based MAH no longer counts for the EU. You need an EU27 Authorised Representative, or an EEA-based MAH, QPPV and PSMF.
Under the Windsor Framework, Northern Ireland stays EU-aligned for goods. So "the UK" splits: GB is third-country, NI follows EU rules — confirm which applies to you.
The practical takeaway: treat GB exactly as you would any non-EU origin. The good news is that your UK technical file and clinical evidence largely transfer — what you are rebuilding is the legal standing and the EU-side conformity, not the science.
For UK medtech, third-country status has a concrete consequence: your route to the German market runs through EU conformity, not the UK system you may have built first.
Your product's risk class sets the burden. Devices run under the MDR; in-vitro diagnostics under the separate IVDR, which pushed most tests into higher, Notified-Body-reviewed classes. Confirm which regulation and class you are in — it drives evidence, timeline and cost. We map that fork in MDR vs IVDR.
A UKCA mark and a UK Responsible Person are for Great Britain. To place the device in Germany you need a CE mark issued via an EU-recognised Notified Body and an EU27 Authorised Representative plus a PRRC. Your UK approval does not open the German door on its own — only a compliant MDR/IVDR route does, and only then does the German market-access question begin.
UK teams, like everyone, tend to treat the CE mark as the finish line. In Germany it is the starting line for reimbursement. In hospitals, payment flows through the DRG case-fee system, with the NUB route for genuinely new methods; in outpatient care it runs through the G-BA and the EBM schedule. None is automatic.
Being listed to be bought is a further step again — German hospital procurement is committee-driven, tender-heavy and slow. See the mechanics in getting a device reimbursed and the buying reality in hospital & tender access, or the full picture in medtech market access.
The most costly assumption a UK pharma company can make is that its MHRA dossier is most of the EU job. Since Brexit the systems are separate, independent and not mutually valid.
The UK authorises medicines through the MHRA under its own framework; the EU authorises through the EMA and national agencies. Neither recognises the other automatically: an MHRA authorisation gives you nothing in Germany, and an EU authorisation gives you nothing in Great Britain. The scientific dossiers overlap heavily, but the procedures, timelines and safety infrastructure diverged — the UK now runs its own Yellow Card pharmacovigilance database rather than EU EudraVigilance for GB products.
So a UK company entering Germany takes a fresh EU route — most innovative medicines through the EU centralised procedure via the EMA, which yields one authorisation valid across the Union (often the reason Germany is chosen as the beachhead). National and mutual-recognition routes exist too. We lay out the choice in the four authorisation routes, and the continuing duties — an EEA-based MAH, QPPV and PSMF, plus GMP/GDP — in pharmacovigilance & GxP.
Once authorised, you may set your own price at launch — but since the 2023 GKV-FinStG reform, only for the first six months. In parallel the G-BA commissions IQWiG to assess your medicine's added benefit against a chosen comparator. That rating — not your UK price, not your list price — sets the negotiated reimbursement price that applies from month seven, with a clawback owed on the difference.
Model the negotiated price, not the launch price. The full mechanism is in AMNOG explained; the wider picture is in pharma market access.
Whatever the track, the German market is the payment decision, not the permission one. About 90% of Germans are covered by statutory health insurance, so the public system's yes is the market.
This is the thesis under all of our work, inbound and outbound: authorized isn't the same as paid. New to the whole entry sequence? Start with the market-entry strategy overview.
As your EU27 Authorised Representative, PRRC or the coordinator of your EEA MAH, QPPV and PSMF, we give a UK company the compliant EU presence Germany now requires — and keep it compliant as you sell.
Five patterns account for most stalled UK entries into Germany. All are avoidable with foresight.
Start with a fixed, written roadmap for your product and track, then plan execution in a working session — the EU footing, the reimbursement evidence and the order to do them in.
A one-off written roadmap for your specific product — which track, which EU route, and where reimbursement, not approval, is the real work.
A focused session to structure the entity-vs-representative decision, plan the added-benefit or DRG evidence, and set the first year.
Yes, but no longer as an EU insider. Great Britain is a third country to the EU, so a UK company needs an EU footing: for devices a CE mark from an EU Notified Body plus an EU27 Authorised Representative and PRRC; for medicines an EU or national authorisation with an EEA-based MAH, QPPV and PSMF.
No. Since Brexit the MHRA and the EMA are separate systems that do not recognise each other. An MHRA marketing authorisation gives you nothing in the EU; you take a fresh EU or national authorisation for the German market.
No. UKCA is the conformity mark for the Great Britain market. To place a medical device on the German (EU) market you need a CE mark issued through an EU-recognised Notified Body.
Yes. A UK Responsible Person covers the GB market only. As a non-EU manufacturer you must appoint an EU27 Authorised Representative to place devices on the EU market; the two roles are separate and both may be needed.
For goods, Northern Ireland remains aligned with EU rules under the Windsor Framework, while Great Britain is a third country. So "the UK" splits, and which regime applies depends on where your product is placed and from where — confirm your specific position.