If you are a manufacturer outside the UK, it is vital that you know how to register a medical device in the UK. This is the difference between a clean launch and stock that is not allowed to be legally sold. The process itself is logical and with the right partner, it can be done quickly.
This guide will take you through MHRA (Medicines and Healthcare products Regulatory Agency) registration step by step. Including who must register, appointing a UK Responsible Person, the DORS submission, the UKCA and CE deadlines. We will also be covering the mistakes that tend to trip up non-UK manufacturers. So let’s get into it.
All manufacturers based outside the UK that place a device on the Great British market must be registered with the MHRA before any units are sold. This covers every risk class from Class 1 bandages to Class 3 implants. Also covers In Vitro Diagnostics (IVDs) and custom made medical devices. There is no exemption for low volumes or marketplace sales. We also cover in another guide, the five steps to export a medical device to the UK, starting with the UKRP.
Please note that MHRA route covers only England, Scotland and Wales. This is because Northern Ireland continues to follow the EU medical device rules, so if you are importing your medical devices into the UK as a whole. We would recommend confirming which market you mean before starting. The steps listed below are for Great Britain:
A non-UK manufacturer cannot register themselves, the MHRA will only accept applications from a UK Responsible Person for all medical devices. a UKRP is a business that has been established in the UK and acts on your behalf. In most cases, you have most likely heard of the role named MHRA Responsible Person otherwise known as a UK representative for medical devices. However, the official term is UK Responsible Person and the duties are all exactly the same, no matter what the role is called.
The appointment of a UKRP is made by a written mandate which will set out what they are authorised to do on your behalf. Before anything is submitted the UKRP must confirm that a declaration of conformity and technical documentation exist. They will then keep a copy of both so they can provide the MHRA access on request. The same applies if you need a UKRP for IVD products.
Your UKRP’s name and address must always appear on the device label, outer packaging or instructors for use. Please note that this is not a formality as it tells regulators and users who to contact in the UK, should devices be found without this, they will be considered non-compliant upon arrival.
The MHRA UK Responsible Person registration is made through DORS (Device Online Registration System). Once the mandate has been signed, they will then open your account and enter the following:
Worth noting that the MHRA will charge a statutory fee per application, instead of per device. This means if you have multiple devices, the sensible option would be to group these together to keep costs down. As a UKRP we also quote the fee at the current published rate so there will be no surprises. With complete and consistent information, the application is usually processed in days rather than weeks. Any delays that we typically see all come from certificates being put in different company names, missing GMDN terms or a class that does not match the certificate.
First-time exporters normally get caught out on Class I devices as these are self-declared, with no Approved Body involved. So in this case, manufacturers will assume they do not require a registration when in fact, they do. Class I devices placed on the GB market but all be registered before sale.
Great Britain has its own conformity mark known as the UKCA mark, but all CE-marked devices will remain accepted under transitional arrangements. The cut-off will depend on the certificate you hold and whether or not it is valid:
After those dates, the UKCA marking for medical devices become unavoidable. For anything above self-declared Class I means that a conformity assessment by a UK Approved Body is required. These assessments take time to arrange so if your CE certificate expires in either 2027 or 2028. it is highly recommended that you start planning now rather than banking on an extension.
Registration is not a one-off so as your UKRP we will remain the point of contact for MHRA which bring the following duties:
One of the most common mistakes that we see is a device registered in the wrong lass. Typically a product that was a Class I under the old directive but then moves up a class under the MDR. This then means the registration no longer matches the certificate and so the MHRA will always query it.
Another mistake we also see is an importer named as the UKRP does not have a mandate. A distributor that holds your stock is not considered a UKRP unless they are formally appointed in writing and able to hold your technical documentation. In most cases, they have not been.
Lastly, we see errors with the labelling, commonly missing the UKRP details. In most cases the registration is fine but the label and instructions for use will still show an EU authorised representative. Making the device non-compliant upon arrival to the UK.
Not to fear, all of these are avoidable when you appoint a competent UKRP who will check class, mandate and labelling before submitting anything. This is exactly how we work at UK RepMed.
UK RepMed’s base is in Farnham, Surrey. We act as a UKRP for many manufacturers around the world with transparent pricing tailored to the devices you want to list on the market. Simply just send us your device list and current certification, we can then provide you with a tailored quote and clear plan on getting you to the GB market.