Importing medical and optical equipment from the UK – UKCA vs CE, documents and duty

Importing medical and optical equipment from the United Kingdom to Poland is one of the most heavily regulated areas of B2B trade. HS Chapter 90 (optical, photographic, cinematographic, measuring, checking, precision, medical and surgical instruments and apparatus) accounts for approximately USD 280 million in annual trade between the UK and Poland — and covers an exceptionally wide range of products: microscopes, X-ray and ultrasound devices, measuring instruments, medical lasers, optical equipment and veterinary apparatus. Every medical device intended for the EU market must satisfy strict regulatory requirements: EU regulations MDR and IVDR impose obligations on both manufacturers and importers. At the same time, following Brexit, the UKCA marking granted by the MHRA (Medicines and Healthcare products Regulatory Agency) is no longer automatically recognised in the EU — creating a serious pitfall for importers purchasing UK-certified medical devices. This article explains how to import medical and optical equipment from the UK correctly, what documents are required, how to verify compliance before purchase, and what role the importer plays under the MDR/IVDR framework.

HS90 Classification — scope and typical products

Chapter HS90 is highly diverse. Correct classification matters both for the duty rate and for identifying the applicable regulatory requirements:

HS subheading	Description	Example products
9001–9005	Optical fibres, lenses, telescopes	Optical fibres, optical lenses, telescopes
9006–9008	Photographic and cinematographic apparatus	Industrial cameras, optical scanners
9011–9012	Microscopes	Optical and electron microscopes
9013	Lasers, liquid crystals	Medical and industrial lasers
9014–9015	Navigational and surveying instruments	Professional GPS, theodolites
9018	Medical apparatus	Ultrasound, stethoscopes, needles, catheters
9019	Physiotherapy apparatus	Electrotherapy and ultrasound devices
9021	Prostheses, orthopaedic appliances	Implants, hearing aids
9022	X-ray apparatus	X-ray, CT scanners, mammography units
9025–9032	Measuring and checking instruments	Industrial thermometers, pressure gauges, sensors

Classification of medical devices is particularly complex — the same device may be classified differently depending on its intended purpose (e.g. a laser for therapeutic use vs. a laser for materials processing).

EU regulations for medical devices — MDR and IVDR

Importing medical devices into the EU (including Poland) is governed by two key EU regulations:

MDR — Medical Devices Regulation (EU) 2017/745 Covers general-purpose medical devices: diagnostic, therapeutic and surgical devices, implants, patient monitoring equipment, etc.

IVDR — In Vitro Diagnostic Regulation (EU) 2017/746 Covers in vitro diagnostic devices: laboratory tests, reagents, blood analysers, pregnancy tests, blood glucose meters, etc.

Medical device classes (MDR)

MDR divides devices into 4 risk classes, which determine the required conformity assessment procedure:

Class	Description	Examples	Conformity assessment
I (low-risk)	Low risk	Tongue depressors, wheelchairs	Manufacturer's own declaration
IIa	Moderate risk	Ultrasound devices, hearing aids	Notified Body
IIb	Higher risk	Ventilators, defibrillators	Notified Body
III (high-risk)	Highest risk	Implants, stents, heart valves	Full assessment by NB

Every Class IIa and above medical device must hold a certificate issued by an EU Notified Body — not by the MHRA.

UKCA vs CE for medical equipment — key differences

This is the most critical issue for importers purchasing medical equipment from the UK. A comparison:

Criterion	CE (EU)	UKCA (UK)
Issuing body	EU Notified Body (e.g. BSI notified EU, TÜV, DNV)	UKCA Approved Body (e.g. BSI UK)
Recognised in EU	YES — required to place on the market	NO — not recognised in the EU from 2025
Recognised in UK	Conditionally (depending on transition period)	YES
Database	EUDAMED (eudamed.ec.europa.eu)	MHRA Device Registration
Validity	Until change of standard or recertification	As above, but for the UK

Practical rule: If a medical device from the UK holds only a UKCA certificate and a UK Declaration of Conformity (issued by a UK Approved Body), it cannot legally be placed on the market in Poland or any other EU country without obtaining a CE certificate from an EU Notified Body.

Historical context: Before Brexit, many leading notified bodies (BSI, SGS, etc.) were based in the UK and issued CE certificates valid for the EU. After Brexit those certificates were either transferred or lapsed — depending on the institution. A CE certificate issued by BSI UK after 1 January 2021 is not valid for the EU.

The importer's role under MDR/IVDR — legal liability

MDR and IVDR impose specific obligations on the importer who places a medical device on the EU market from the UK. An importer is not merely a commercial intermediary — they assume significant legal responsibility:

Importer obligations for medical devices (Article 13 MDR):

1. Compliance verification — before placing on the market, the importer must verify that the device holds a valid CE marking, Declaration of Conformity and Technical Documentation
2. Document retention — for a minimum of 10 years (15 years for implants)
3. EUDAMED registration — both the device and the importer must be registered in the European database of medical devices
4. Labelling — the importer must add their details to the label or outer packaging
5. Incident reporting — the importer is required to report serious incidents to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)
6. Traceability (UDI) — the device must carry a Unique Device Identifier compliant with MDR requirements

Breach of MDR importer obligations may result in fines, a ban on sale and civil liability for harm caused to patients.

How to verify compliance before purchasing from the UK

Before placing an order for medical equipment from the UK, the importer should carry out a compliance check. Checklists are set out below:

CE certificate verification: - [ ] Check the CE certificate number in the EUDAMED database or with the Notified Body - [ ] Verify that the certificate is current (check validity dates) - [ ] Confirm that the certificate was issued by a Notified Body based in the EU (not the UK) - [ ] Check that the certificate covers exactly this model/variant of the device

Documents to request from the UK supplier: - EU Declaration of Conformity - EU Notified Body certificate - Technical Documentation (Technical File) — available on request - Instructions for use in Polish - Confirmation of EUDAMED registration (for Class IIa and above) - Calibration certificate (for measuring instruments)

Customs documents for clearing medical equipment from the UK

Standard documents: - Commercial invoice with HS code, value and device description - Packing list - CMR or Air Waybill - Statement on Origin / EUR.1 (for 0% TCA duty rate)

Documents specific to medical devices: - CE Declaration of Conformity - EU Notified Body certificate (copy) - EUDAMED registration confirmation (SRN — Single Registration Number) - For X-ray apparatus: authorisation from the President of the National Atomic Energy Agency (PAA) - For Class 3B and 4 laser apparatus: notification to the Sanitary Inspectorate (Sanepid)

Duty and VAT rates for medical apparatus HS90

Customs duty rates on HS90 imports from the UK:

Category	TCA duty rate	MFN rate
Medical and surgical apparatus (HS9018)	0%	0–2.7%
X-ray apparatus (HS9022)	0%	0%
Microscopes (HS9011–9012)	0%	0–3.7%
Measuring instruments (HS9025–9032)	0%	0–3.7%
Optical apparatus (HS9001–9005)	0%	0–6.7%
Lasers (HS9013)	0%	0–3.7%

For most HS90 medical apparatus, the applicable rate is 0% under both TCA and MFN. However, for certain sub-categories (e.g. optical lenses) MFN rates can reach 6.7% — making a proof of origin document financially valuable.

Import VAT: 8% for medical devices classified as such (reduced rate), 23% for other HS90 products that are not medical devices.

Measuring and optical instruments — additional requirements

Unlike medical devices, industrial measuring instruments (HS9025–9032) are not subject to MDR, but may be subject to:

• The MID (Measuring Instruments Directive) — for instruments used for commercial purposes (scales, meters, flow meters)
• The ATEX Directive — for instruments used in explosive atmospheres
• Metrological regulations — GUM (Central Office of Measures) certification for instruments used in legal metrology

Microscopes, industrial cameras and general-purpose optical instruments are generally subject only to the Low Voltage Directive (LVD) and EMC — less stringent requirements than MDR.