Medical Devices
Class I devices are self-declared, but if you are outside the UK you still need a UK Responsible Person and MHRA registration before selling in Great Britain. That is the whole job, and it should not cost enterprise money. Taylored acts as UKRP for Class I manufacturers worldwide, registers your devices with the MHRA and checks your CE or UKCA status against the transition deadlines.
Straightforward devices deserve a straightforward service: fixed annual fee, MHRA registration handled, one named contact.
Under the UK Medical Devices Regulations 2002, a manufacturer established outside the United Kingdom must appoint a UK Responsible Person (UKRP) before placing a device on the Great Britain market. The UKRP is a UK-established company that registers your devices with the Medicines and Healthcare products Regulatory Agency (MHRA), keeps your technical documentation available and acts as the MHRA's point of contact.
For Class I devices, which are self-declared and do not need an Approved Body, that is most of the regulatory work. There is no conformity assessment audit, no certificate to renew and no notified body fee. What there is: a UKRP appointment, an MHRA registration for each device, a label that names the UKRP, and a technical file that supports your declaration of conformity.
The exceptions are Class I devices that are sterile, have a measuring function or are reusable surgical instruments. Those need an Approved Body for the relevant aspect, and we tell you straight away if your device falls into one of those groups.
Because the work is proportionate, the fee should be too. Large providers tend to quote one price whatever the class. We do not think a Class I manufacturer should pay for a service designed for Class III.
Taylored is named as your UK Responsible Person, with our details on your labelling and in the MHRA registration. We hold your technical documentation and declaration of conformity, and we are the contact the MHRA calls.
Overseas manufacturers cannot register directly; the UKRP does it. We register your devices, keep the registration current when you add or change products, and handle fee payments and renewals.
We confirm which marking your device carries, whether CE marking is still accepted for it in Great Britain under the current transition dates, and what a UKCA step would involve if you need one later.
We also review your labelling and instructions for use against UK requirements and flag anything that would cause a problem at the border or with a distributor.
For a Class I device with a complete technical file, the process is short. Three steps:
You send us the device description, intended purpose, classification rationale, declaration of conformity and labelling. We confirm the class, check for sterile, measuring or reusable surgical status, and tell you if anything is missing.
We are appointed as UKRP, your labels are updated with our details for the next print run, and we submit the MHRA registration for each device or device family.
Once the MHRA confirms registration you can place the device on the GB market. We keep the registration current, handle vigilance reporting and remain your named UK contact.
If your technical file is incomplete, we tell you what a Class I file needs and can help you close the gaps before registration.
Class I UKRP cover with Taylored includes:
Formal appointment as UK Responsible Person under the UK Medical Devices Regulations
MHRA device registration for every device and device family, including updates
Holding your technical documentation and declaration of conformity for MHRA access
Label and instructions-for-use review against UK requirements
Vigilance: incident reporting to the MHRA and liaison on field safety actions
A named contact who answers MHRA and distributor queries on your behalf
MHRA registration fees are passed through at cost. Everything else is in the fixed annual fee.
CE-marked devices continue to be accepted in Great Britain until the published transition deadlines, which depend on the device's route and the legislation it was certified under. For most Class I devices that means CE marking remains valid for now, and UKCA is a later step rather than a blocker.
The dates have moved more than once, and the rules for devices that were upclassified under the EU MDR are different again. We confirm which date applies to your device and plan the UKCA step, if needed, so it never becomes a last-minute scramble.
Our medical device compliance UK page covers the full picture: UKCA marking, technical documentation, classification and QMS support for higher-risk devices.
UKCA marking, technical documentation, classification and quality management support for devices placed on the Great Britain market, from Class I to Class III.
Class I UKRP cover is a fixed annual fee, agreed in writing before you appoint us. What moves it is the number of devices and device families to register and whether your technical file and labelling are ready or need work first. MHRA registration fees are passed through at cost.
We do not publish a rate card, but we will say this: our Class I fee is set for a Class I workload, not borrowed from a service built for implantables. If you have a quote from an enterprise provider, send it to us and we will tell you what you would actually be paying for.
We also act as UKRP for Class IIa, IIb and III devices, in vitro diagnostics and software as a medical device, and support manufacturers through UKCA conformity assessment with an Approved Body. If your range grows or your device is upclassified, the same team carries on.
Higher classes bring a quality management system into scope. Our ISO 13485 consultancy covers gap analysis, QMS build and internal audits for manufacturers who need one.
Generally no. Class I devices are self-declared by the manufacturer, unless the device is sterile, has a measuring function or is a reusable surgical instrument. Those variants need an Approved Body for that specific aspect, and we confirm which applies to yours before quoting.
For now, yes. CE marking is accepted in Great Britain until the published transition deadlines, which vary by device route. We confirm which date applies to your device and plan the UKCA step if and when it is needed.
Overseas manufacturers cannot register directly. Registration is done through the UK Responsible Person, and we handle it as part of the service, including updates when you add devices and the registration fees, which are passed through at cost.
With a complete technical file and labelling, the appointment and submission can be done within days, and the MHRA typically confirms registration within a few weeks. Incomplete files are the usual cause of delay, which is why the device review comes first.
Yes, if you are the manufacturer and you are established outside the UK. A distributor or importer does not take on the manufacturer's UKRP obligations, although importers have duties of their own. Some distributors offer to act as UKRP; we would suggest keeping the role independent of your sales channel.
We act as UK Responsible Person for device manufacturers across Europe, North America and Asia, and our regulatory team works on UKCA, technical documentation and ISO 13485 every day. For Class I that means a proportionate fee, quick registration and a contact who knows the MHRA's questions before they are asked.
