UKCA Marking Consultant for Medical Devices in the Netherlands

UKCA Marking is a critical regulatory requirement for placing medical devices on the market in Great Britain. Following the post-Brexit transition, obtaining the UKCA mark has become mandatory for manufacturers seeking access to the UK healthcare market. The process involves preparing comprehensive technical documentation, completing conformity assessments, and ensuring full compliance with the UK Medical Devices Regulations (UK MDR 2002). For medical device manufacturers and exporters in the Netherlands, this presents a strategic opportunity to strengthen their presence in the UK and expand global market reach.

What is UKCA Marking for Medical Devices?

UKCA (UK Conformity Assessed) Marking is the certification required to place medical devices and IVDs on the market in Great Britain (England, Scotland, and Wales), replacing CE marking post-Brexit. It demonstrates compliance with the UK Medical Devices Regulations 2002 (UK MDR 2002) and confirms that the device meets essential safety, quality, and performance requirements.

To obtain UKCA Marking, manufacturers must complete a conformity assessment, maintain comprehensive technical documentation, and implement a robust post-market surveillance system before launching the product in the UK.

Seamless UKCA Marking for Medical Devices in the Netherlands

Planning to launch your medical device in Great Britain? For manufacturers and distributors in the Netherlands, understanding and navigating the UKCA marking process is essential for smooth market access and regulatory compliance under UK MDR 2002.

Steps to Achieve UKCA Certification:

Classify Your Device
Identify your medical device or IVD classification as per UK MDR 2002 requirements.
Choose the Right Compliance Route
Determine the applicable conformity assessment procedure, depending on the device risk class.
Prepare Technical Documentation
Compile complete documentation including device specifications, intended use, clinical evaluation, risk analysis, and labeling.
Register with MHRA
Submit your device registration through the Medical Devices Information System (MDIS) to the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Undergo Regulatory Review
MHRA or an Approved Body (if required) will review your submission to verify compliance with UK standards.
Obtain UKCA Certification
Upon successful assessment, affix the UKCA mark and confidently enter the UK market.
Also Read: Guide to MHRA medical device registration

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UKCA Marking Timelines: Stay Compliant & Market-Ready in the Netherlands

If you’re a medical device or IVD manufacturer or distributor based in the Netherlands planning to sell in Great Britain, understanding the UKCA marking deadlines is essential for maintaining market access and regulatory compliance.

Key UKCA Marking Timelines for Medical Devices:

Until June 30, 2025 – You may continue to place products on the GB market using either the CE mark or the UKCA mark.
From July 1, 2025 – New UK medical device regulations are expected to take effect, impacting both CE- and UKCA-marked products.
Regulatory Updates – The UK government may revise timelines or requirements, so regular updates via MHRA and official UK sources are critical.

MHRA Registration & UKCA Marking for Medical Devices in the Netherlands

To sell medical devices in Great Britain, manufacturers in the Netherlands must comply with UKCA marking and MHRA registration requirements under UK MDR 2002.

Key Requirements:

UKCA Marking is mandatory for all medical devices and IVDs from July 1, 2025, replacing CE marking in Great Britain.
MHRA Registration must be completed before placing any device on the UK market.
UK Responsible Person (UKRP) is required for non-UK manufacturers to manage compliance.
Devices follow UK classification: Class I, IIa, IIb, III, determining the assessment route.

Ensure full regulatory compliance and smooth UK market entry with proper UKCA and MHRA procedures.

Smooth UKCA Marking for Medical Devices – Your Expert Partner in the Netherlands

Operon Strategist provides end-to-end support to medical device manufacturers, importers, and distributors in the Netherlands for seamless UKCA marking, MHRA registration, and UK Responsible Person (UKRP) appointment. Our expertise ensures full compliance with UK MDR 2002 and smooth entry into the UK medical device market.

Our UKCA Marking Services Include:

UKCA Technical File Preparation
MHRA Registration via DORS
UK Responsible Person (UKRP) Appointment
Device Classification & Conformity Route Guidance
QMS Setup aligned with UK MDR & ISO 13485
Regulatory Query Handling & Submission Follow-up

Simplify UK Market Access with Operon Strategist

Expanding your medical device business to the UK? Operon Strategist simplifies the complex UKCA process for manufacturers in the Netherlands. Whether you’re launching a new device or transitioning from CE to UKCA, we guide you through every step with:

Detailed Compliance Reviews
Tailored Regulatory Advice
Complete Documentation Handling
Deadline-Oriented Execution

Ready to Enter the UK Market?

FAQs

What is UKCA marking for medical devices?

UKCA (UK Conformity Assessed) marking is a certification that indicates a medical device complies with UK regulations and is approved for sale in Great Britain (England, Scotland, and Wales).

Is UKCA marking mandatory for medical devices sold in the UK?

Yes, UKCA marking is mandatory for all medical devices and IVDs placed on the UK market after June 30, 2025, replacing the CE mark in Great Britain.

Do I still need MHRA registration if I have UKCA marking?

Yes, all medical devices must be registered with the MHRA before being marketed in the UK, regardless of their certification status.

What is a UK Responsible Person (UKRP)?

A UKRP is a legal representative appointed by non-UK manufacturers to communicate with MHRA and ensure regulatory compliance for devices sold in the UK.