Importing Medical Devices from the UK – MDR, UKCA and Registration in Poland

Importing medical devices from Great Britain to Poland and other EU member states after Brexit requires a thorough understanding of two separate regulatory frameworks: the UK framework (based on UK MDR 2002 and the UKCA mark) and the EU framework (EU MDR 2017/745 and EU IVDR 2017/746, using the CE mark). Medical devices — from simple plasters and thermometers to orthopaedic implants, ventilators, and in-vitro diagnostics — are subject to strictly defined safety requirements, certification by a Notified Body, and registration with the relevant regulatory authorities. Since the UK left the EU, both systems operate independently: a UK product bearing the UKCA mark cannot automatically enter the EU market, and an EU product bearing the CE mark cannot be freely sold in the UK without meeting additional MHRA requirements. This article explains what this means in practice for importers, what documents are required for customs clearance, the role of the EU importer, and how device registration in Poland works.

UK MDR vs EU MDR — Key Differences After Brexit

After Brexit, the UK and the EU have separate certification systems for medical devices. Understanding the differences is the foundation of compliant importing.

Marks and Certification Systems

Aspect	UK (Great Britain)	EU (including Poland)
Mark	UKCA (UK Conformity Assessed)	CE (Conformité Européenne)
Legislation	UK MDR 2002 (as amended), UK IVDR 2022	EU MDR 2017/745, EU IVDR 2017/746
Approved body	UKAB (UK Approved Body)	Notified Body listed in NANDO
Registration	MHRA (UK)	EUDAMED (EU)
Valid market	UK (England, Wales, Scotland)	Entire EEA

Note on Northern Ireland: Under the Windsor Framework, medical devices placed on the market in Northern Ireland must comply with EU MDR/IVDR and carry the CE mark. This is an exception to the UKCA rule that applies to the rest of Great Britain.

What Does This Mean for the Importer?

If you are bringing a medical device from the UK into Poland, you must ensure it carries the CE mark in compliance with EU MDR or EU IVDR (depending on the device class). The UKCA mark alone is not sufficient to place a device on the EU market.

A UK manufacturer selling into the EU market has three options: 1. Obtained a CE certificate from a Notified Body within the EU (or one recognised by the EU) — the device may enter the EU market 2. Has an Authorised Representative (AR) in the EU — mandatory since 2021 3. Manufactures in compliance with EU MDR via a facility within the EU — in which case certification takes place directly in the EU

Medical Device Classes and Certification Requirements

EU MDR 2017/745 divides medical devices into four risk classes. The higher the class, the stricter the requirements:

Class	Risk Level	Examples	Certification Required
Class I	Low	Plasters, surgical scissors, corrective spectacles	Manufacturer's Declaration of Conformity (self-certification)
Class IIa	Moderate	Hearing aids, single-use contact lenses, catheters	Notified Body (NB)
Class IIb	Higher moderate	Ventilators, infusion pumps, non-active implants	Notified Body (NB)
Class III	Highest	Active implants (pacemakers), coronary stents, biomaterials	Notified Body (NB) + design dossier approval

In-vitro diagnostics (IVD) are governed by EU IVDR 2017/746, with a classification of A, B, C, D.

The Role of the EU Importer of Medical Devices

After Brexit, importers of medical devices from the UK carry specific obligations under EU MDR. The EU importer (for example, a Polish company sourcing devices from the UK) is responsible for:

1. Document verification — checking that the device holds a valid CE certificate issued by a Notified Body
2. Checking the manufacturer's registration in EUDAMED — mandatory since 2024 for devices of Class IIa and above
3. Labelling — ensuring the device or its packaging displays: the CE mark, the NB identification number (for Classes IIa/IIb/III), the name of the EU importer, and the UDI (Unique Device Identifier)
4. Retaining documentation — for a minimum of 10 years (implants: 15 years) from the date of the last supply
5. Reporting incidents — the importer must report to URPL any serious incident involving an imported device

Under EU law the importer is treated as the manufacturer if it modifies the device, changes its intended purpose, or removes or alters the markings.

Medical Device Registration in Poland — URPL and EUDAMED

The Office for Registration of Medicinal Products (URPL)

In Poland the competent authority for medical devices is URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych — Office for Registration of Medicinal Products, Medical Devices and Biocidal Products). The importer is required to:

• Register the device in the Medical Devices Register maintained by URPL before placing it on the market in Poland
• For Class I devices — a notification entry is sufficient (notification, not an approval application)
• For Class IIa and above — verify that the manufacturer has completed registration in EUDAMED

EUDAMED — European Database on Medical Devices

EUDAMED (European Database on Medical Devices) is the EU's central system holding information on medical devices, manufacturers, and certificates. From 2025, full EUDAMED functionality (including the public UDI search) is being progressively rolled out.

The importer should verify in EUDAMED whether: - The UK manufacturer is registered as an Economic Operator - The device's CE certificate is current and valid - The device has been assigned a UDI-DI (Device Identifier)

Customs Documents for Importing Medical Devices from the UK

Customs clearance for medical devices from the UK to Poland requires the standard import documents, supplemented by compliance documentation:

Customs Documents

Document	Notes
Commercial invoice	Including HS code (chapters 9018–9022 or others), customs value, Incoterms
Packing list	Detailed packaging breakdown
CMR / AWB	Transport document
Customs declaration (SAD)	Prepared by the customs agent in AES/TARIC
Proof of origin	For zero-rate duty under TCA

Compliance Documents (required by URPL / border authorities)

Document	Notes
EU Declaration of Conformity (DoC)	Signed by the manufacturer, in accordance with EU MDR
CE certificate issued by a Notified Body	For Classes IIa, IIb, III
Instructions for Use (IFU) in Polish	Mandatory for Class I devices and above
UDI-DI number	For Class IIa and above
Proof of registration in EUDAMED	For the manufacturer and the certificate

Duty Rates on Medical Devices from the UK

Medical devices from the UK may benefit from a zero rate of customs duty under the TCA (Trade and Cooperation Agreement), provided the rules of origin are satisfied.

Type of Device	HS Code	Duty Rate (TCA preference)
Medical diagnostic apparatus	9018	0% (TCA preference)
Orthopaedic implants	9021	0%
X-ray apparatus	9022	0%
Single-use items (e.g. syringes)	9018.31	0%
Corrective spectacles	9004	0%

For combination products (medical device + medicinal product — so-called Drug Device Combinations) or devices with electronic components, the HS classification may not be straightforward. We recommend consulting a customs agent before the first shipment.

VAT on medical devices in Poland: Class I–III medical devices — 8% VAT (for devices listed in the Annex to the VAT Act). Some devices may benefit from a VAT exemption or a 0% rate (e.g. prostheses for people with disabilities).

Common Mistakes When Importing Medical Devices from the UK

1. No CE marking — importing a device bearing only the UKCA mark without confirmation of a CE certificate for the EU market
2. Outdated Declaration of Conformity — a DoC issued before EU MDR came into force, or without the signature of an authorised person
3. No IFU in Polish — the instructions for use must be in the official language of the destination country
4. No importer name on the packaging — EU MDR requires the EU importer's details to appear on the device or its packaging
5. Incorrect tariff classification — IVD diagnostic devices confused with other laboratory instruments