Guidance

Register as a manufacturer to sell medical devices

Register a manufacturer or authorised representative (agent) for a manufacturer, to sell medical devices, including in vitro diagnostic (IVD) medical devices.

Overview

If you place certain medical devices on the EU market you or your designated authorised representative must register with the competent authority (national health regulator) in the EU state where you have an office or place of business. In the UK, Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority for the registration of medical devices. MHRA will only register manufacturers or authorised representatives that have a place of business in the UK.

Before you register, you must first complete a conformity assessment, so you can put the CE marking on your products.

When you must register

Registering your device according to the EU Directives

For devices in compliance with the Medical Devices Directive (MDD), the Active Implantable Medical Devices Directive (AIMDD) and the in vitro Diagnostic Medical Devices Directive(IVDD).

It is a requirement of the UK Medical Device Regulations that you inform MHRA, the UK competent authority, when you first place certain devices on the market. You must register if you or your company sells, leases, lends or gifts:

  • class I devices you have manufactured
  • class I devices you have refurbished or re-labelled with your own name
  • any system or procedure pack containing at least one medical device
  • custom-made devices
  • IVDs you have manufactured
  • IVDs undergoing performance evaluation

We do not register devices classified as class IIa, IIb, III or active implantable devices which are not custom-made. For these, you need to follow the appropriate conformity assessment route, which includes assessment by a notified body.

Manufacturers without a place of business in the EU need to appoint an authorised representative in the EU. Only one authorised representative can be designated within the EU for each device type.

Registering your device according to the new EU Regulations

The EU Medical Devices Regulation (MDR) and in vitro Diagnostic Medical Devices Regulation (IVDR) entered into force on 25 May 2017, when the three- and five-year transition periods began. The MDR and IVDR will fully apply in EU Member States from 26 May 2020 and 2022 respectively.

During the transition period, devices can be put on the market under the current EU Directives, or the new Regulations (if you fully comply with the new Regulations).

During the transition period, the registration process remains unchanged for devices that comply with the Directives (the MDD, AIMDD and IVDD). However, if you wish to register devices under the new EU Regulations, you will need to tick the relevant box on the registration form to indicate that your devices fully comply with the new Regulations and not the Directives.

The MHRA will now accept registrations of the following devices, if they fully comply with the new Regulations:

  • Class I medical devices
  • Class A in vitro diagnostic medical devices

Find out more about the new MDR and IVDR.

Authorised representatives

If you are a designated authorised representative (AR) of a non-EU manufacturer we require documentary evidence supporting your position in the form of a headed letter (letter of designation) or signed contract, which states the company name and address for both the overseas manufacturer and the AR. This document must state that the AR is acting with the consent of the overseas manufacturer and the legislation that applies for the devices being placed on the UK market.

If you are taking over the role from an existing authorised representative we need a new headed designation letter/contract and a copy of the letter cancelling the service of with the previous authorise representative.

The European Commission has guidance for authorised representatives.

Eligible devices and coding system

Class I devices

Examples of class I devices include:

  • dental and surgical instruments
  • stethoscopes and ophthalmoscopes
  • bandages and splints
  • spectacle lenses and frames
  • treatment chairs and hospital beds
  • stand-alone software

The European Commission has a guidance document ‘Definitions of “medical devices”, “accessory” and “manufacturer”.

Custom-made devices

There is further information about custom-made devices and examples of the information we need.

If you are submitting a registration for a custom made active implantable device, you are required to provide us with a copy of the instructions for use and the device labelling.

System and procedure packs

You will need to register if your company:

  • places devices bearing the CE marking on the market, under your own name in a system or a procedure pack within their intended purposes and within the limits of uses specified by their original manufacturers
  • sterilises, for the purpose of placing on the market under your own name, systems or procedure packs or other CE marked medical devices designed by the manufacturer to be sterilised before use

To register your medical devices with MHRA, you must use Global Medical Devices Nomenclature (GMDN) to describe your devices. You do not need to be a member of the GMDN Agency to select GMDN terms within our online registration system.

In vitro diagnostic medical devices

Examples of IVD medical devices include cultures, reagents, antigens, serums, plasmas and testing kits and equipment for these.

To register your IVD devices with MHRA, you must use Global Medical Devices Nomenclature (GMDN) to describe your devices.

CE marking

There is further information about CE marking and the legal requirements for placing medical devices on the market.

Once you are satisfied that your devices meet all the relevant requirements, you can register with MHRA.

Apply to register with the Device Online Registration System (DORS)

Using DORS you can register medical devices and IVD devices and manage your account details. You need to create an account with MHRA and wait for an email confirming that it’s active before you can start registering your devices.

Fees

A statutory fee of £100 applies for the processing of new and/or subsequent changes to medical device(s) and/or in vitro diagnostic device(s) registrations. The fee is chargeable per application.

Start the registration process by applying for an account with MHRA. We will email when your account has been activated.

We are currently changing to a new online service. If you are already registered with MHRA your registration is still valid.

Making changes to your registration

If we’ve told you we have migrated your registration to our new online system, you can access your MHRA account and registration details.

If you registered with MHRA before 1 July 2018 and have not yet been migrated to our new online system, you can still access your existing DORS registration.

You must notify us of changes to your registration details and a statutory fee is chargeable for a change of:

  • your registered address
  • company name
  • company type eg. if you become a limited company
  • adding device(s) to your registration record
  • status of an IVD, for example a change from ‘performance evaluation’ to ‘new’
  • change of authorised representative

The fee is not chargable for:

  • change of contact details including email address, telephone numbers
  • adding products to registered devices
  • removing devices or products from your registration record

Register of manufacturers

Once registered, your company name and address are added to the Public Access Database for Medical Device Registration. Records are listed by manufacturer name, address, MHRA reference number and list the device types registered with us.

Manufacturers of in vitro diagnostic medical devices are not published on this database, as the IVD Directive confidentiality clause still applies.

Registering your devices with MHRA does not mean that we give you any form of accreditation, certification or approval for the device. It is just a notification of your activities.

Contact

If you are not sure whether you should register your devices with MHRA, email devices.regulatory@mhra.gov.uk.

If you are already registered with us and have a question about your registration details contact us on 020 3080 7272 or email device.registrations@mhra.gov.uk quoting your reference number.

Published 18 December 2014
Last updated 16 July 2018 + show all updates
  1. Updated to refer to the new Medical Device Regulations, added further links for clarification, and includes links to access the new online system for Device Registrations.
  2. Updated to include information about increase to the Devices Registration Fee
  3. Contact details updated.
  4. Link changed for 'Definitions of "medical devices", "accessory" and "manufacturer" (MEDDEV 2.1/1)'
  5. Amended information to clarify use of the Device Online Registration System (DORS).
  6. First published.