Industry · Medical Devices
UK & EU market access for medical device companies

MDR, IVDR and MHRA obligations meet customs reality: we act as your Importer of Record, EU Authorised Representative and UK Responsible Person — so devices reach the UK and all 27 EU member states compliantly, without a local entity.

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Selling medical devices into the UK and EU without a local entity

Medical devices carry a double burden at the border: the customs layer that applies to every import, and a regulatory layer — the EU Medical Device Regulation (MDR 2017/745), the IVD Regulation (IVDR 2017/746) and the UK's MHRA regime — that determines whether your product may be placed on the market at all. Both layers demand locally established parties: an importer for customs, an Authorised Representative and registered economic operators for the regulation. A non-UK/EU manufacturer without local infrastructure fails both tests.

flexfrontier covers the full stack: Importer of Record for the customs side, EU Authorised Representative and UK Responsible Person for the regulatory side, and the VAT and EORI registrations the shipments run on — one agreement, both markets.

EU: the MDR/IVDR operator chain

The MDR made the economic-operator chain explicit. A non-EU manufacturer needs an Authorised Representative (EC REP) established in the Union — named on the labelling, holding the technical documentation and declaration of conformity at authorities' disposal, and registered in EUDAMED with a Single Registration Number. Importers and distributors carry their own verification duties under Articles 13 and 14, and every device needs UDI assignment and registration. The AR appointment is not a formality: the representative shares legal exposure for defective devices, which is why generic mailbox providers are the wrong answer in this sector.

We act as your EU AR with the documentation discipline the MDR expects — technical file verification, EUDAMED registration, vigilance support and competent-authority liaison — and because we are also your importer, the Article 13 checks happen in one pair of hands rather than being argued about between suppliers.

UK: MHRA registration and the UK Responsible Person

The UK runs its own system under the UK Medical Devices Regulations 2002: non-UK manufacturers must appoint a UK Responsible Person, who registers the devices with the MHRA before they are placed on the market in Great Britain. CE-marked devices continue to be accepted in Great Britain under transitional timelines running into 2028–2030 depending on device type and certification route, but the UK RP and MHRA registration requirements apply now, regardless of which marking your device carries.

We provide the UK RP appointment and MHRA registrations alongside the EU roles, keeping one consistent technical file across both markets — and one contact when either regulator asks questions.

Demo units, loan sets and clinical stock: hospitals, distributors and clinical sites routinely refuse to act as importer for equipment they do not own. Our IOR service was built for exactly these flows — evaluation units, loan kits, trial supplies — with the regulatory registrations checked before shipment so devices are not held at the border.

Customs for devices: classification, valuation, reliefs

Device imports get audited on the same points as any other goods, with sector twists: classification across headings 9018–9022 (and the accessories and spare-part lines around them) drives duty outcomes; valuation must correctly treat software, licences and instruments-plus-consumables bundles; and returned-goods relief and inward processing can remove duty entirely on repair and refurbishment loops. As your importer we build these positions before the first shipment, and as your Exporter of Record we run the outbound half of service and repair flows with proof of export intact.

Who we work with

  • Device manufacturers in the US, Asia and post-Brexit UK/EU selling into the other market.
  • IVD and diagnostics companies supplying labs and healthcare systems.
  • Digital health and wearables businesses whose products cross the device boundary.
  • Distributors and service organisations moving loan sets, spares and field-replacement units.
At a glance
Territories
UK + 27 EU member states
Key frameworks
MDR 2017/745 · IVDR 2017/746 · UK MDR 2002
Representation
EU AR (EC REP) · UK Responsible Person
Setup time
From 24 hours
Request a consultation
One partner, every obligation
How our services map to medical devices

Every flexfrontier service applied to the realities of the device supply chain — click through for the full picture on each.

Importer of Record

Devices · IVDs · demo & loan units

We act as the legal importer for devices entering the UK and EU — including demo units, loan sets and clinical evaluation stock that hospitals and distributors refuse to import themselves.s liability, and your spares inventory clears into local warehouses compliantly.

EU Authorised Representative

MDR / IVDR · EC REP · EUDAMED

The mandatory EC REP appointment for non-EU manufacturers: named on your labelling, registered in EUDAMED, verifying technical documentation and liaising with competent authorities.

UK Responsible Person

MHRA registration · Great Britain market

The UK-established person who registers your devices with the MHRA and carries the UK-side obligations — required before any device is placed on the GB market.

VAT & EORI

Registrations · reliefs · import VAT recovery

EORI numbers obtained and linked, VAT structured so import VAT on devices is deferred or recovered, and rate treatment confirmed per product and market.

Exporter of Record

Returns · repairs · field replacements

Devices going back for service, recall rework or end-of-trial return get a compliant exporter — with proof of export preserved for VAT purposes.

EPR Compliance

Packaging · WEEE (electromedical) · batteries

Electromedical equipment sits in WEEE scope and device packaging counts toward packaging EPR — we map the streams that apply and manage the registrations.

Common questions
Medical devices — FAQs

  • Do we need both an EU Authorised Representative and a UK Responsible Person?

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    Yes, if you sell in both markets. The EU AR (EC REP) requirement under the MDR/IVDR and the UK Responsible Person requirement under the UK regulations are separate appointments in separate jurisdictions — one representative cannot cover both. flexfrontier provides the two roles under a single agreement.

  • Can you act as Importer of Record for medical devices?

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    Yes. We act as IOR for devices, IVDs, demo units, loan sets and clinical evaluation stock entering the UK and EU — with the regulatory registrations verified before shipment so goods are not stopped at the border, and import VAT structured to be recoverable.

  • Are CE-marked devices still accepted in the UK?

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    Great Britain continues to accept CE-marked devices under transitional timelines running into 2028–2030, depending on the device type and certification route. UK obligations still apply now — including UK Responsible Person appointment and MHRA registration before placing devices on the GB market.

  • Who registers our devices with the MHRA?

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    The UK Responsible Person. Non-UK manufacturers cannot register directly: the UK RP submits and maintains the MHRA registrations on your behalf and is named as your UK contact. We provide this as part of our representation service.

  • What is EUDAMED and do we need to be in it?

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    EUDAMED is the EU's medical device database. Manufacturers, Authorised Representatives and importers register as economic operators to obtain Single Registration Numbers, with device and UDI data registered as the database's modules become mandatory. We handle the actor registration and keep your records aligned as requirements phase in.

  • Can you import demo units and loan sets that hospitals won't import?

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    Yes — this is one of the most common device flows we run. Clinical sites and distributors routinely refuse importer responsibility for equipment they do not own, so we act as IOR for evaluation, loan and trial equipment, and as Exporter of Record when it comes back out.

  • How is import VAT handled on medical devices?

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    As with other goods, correctly structured imports keep VAT recoverable rather than a sunk cost — via UK Postponed VAT Accounting and EU deferment mechanisms. Some devices and healthcare supplies attract reduced or zero rates in certain countries; we confirm the treatment per product and market before shipment.

  • Do medical devices trigger WEEE or other EPR obligations?

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    Often, yes. Electromedical devices are a WEEE category in the UK and EU, batteries inside devices carry their own obligations, and product packaging counts toward packaging EPR. We map which streams apply to your range and manage the registrations and reporting.