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 authorised representative (agent) must be registered 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 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.

Medical devices are categorised by type (class) and your registration will include the type of device you sell.

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

When you must register

You must inform a competent authority when you first place your device 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
  • ‘in vitro diagnostic medical device’ (IVD) you have manufactured

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 product type.

Eligible devices and their codes

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

There is a more detailed list of typical class I devices and their generic device codes on the RG2 registration form.

Examples of products that are not medical devices include:

  • toiletries
  • tattooing instruments
  • protective equipment
  • swabs, wipes and disinfectants

The European Commission has a guidance document Definitions of “medical devices”, “accessory” and “manufacturer” (MEDDEV 2.1/1).

Custom-made devices, systems and procedure packs

Examples of these are listed on the RG2 registration form with the generic device codes.

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

In vitro diagnostic medical devices

Examples of in vitro diagnostic (IVD) medical devices include cultures, reagents, antigens, serums, plasmas etc and testing kits and equipment for these.

You will need to specify the correct codes for your IVD medical devices.

Either of the following nomenclatures can be used to register with the MHRA:

If you manufacture IVD medical devices that are then sold (either by you or another company) you will need to register using the RG3 registration form.

CE marking

The CE marking is a declaration of conformity with the EU’s Medical Devices Directive (MDD).

For class I devices (those with the lowest risk level) you must ensure that your product complies with all the relevant essential requirements of the MDD and draw up a written statement to this effect (self-declaration).

If you manufacture sterile products or devices with a measuring function you must apply to a notified body for certification.

Once you are satisfied that your products meet all the relevant essential requirements, you can register with MHRA (or other EU authority), then you can put the CE mark on the product(s) and place them on the market.

Find out more about the conformity assessment for medical devices.

Apply to register

The form you use to register depends on whether the device you are selling is an IVD or ‘general’ medical device.

Register online

You can register both medical devices and IVD devices online as well as manage your details. You will need to set up an account before you can do this.

Create an account on the device online registration system (DORS) and we will email you when it’s activated.

Register by paper

MHRA will stop accepting paper registrations from 11 May 2015.

Download form RG2 to register with MHRA as a manufacturer, seller or agent for a medical device. RG2 form for ‘general’ medical devices (PDF, 74.3KB, 12 pages)

Download form RG3 to register with MHRA as a manufacturer, seller for an in vitro diagnostic medical device. Form RG3 for ‘general’ medical devices (PDF, 114KB, 9 pages)

You can register multiple devices on a form, using additional pages if necessary.

If you are an authorised representative of a non-EU manufacturer you must provide written evidence that you are acting with the consent of the manufacturer. For example, a letter of designation or a contract.

The form can be emailed to along with a copy of the online payment transaction receipt showing the date of payment, amount paid and the transaction ID number to: device.registrations@mhra.gsi.gov.uk

You must pay £70 for each form you send requesting such changes.

Payment can be made online or by BACs transfer.

On the payment form we need information so we can link the payment to the correct registration form(s). For new registrations please provide the following information:

  • the type of form (RG2 or RG3)
  • date of completing the form
  • authorised representative’s name (if applicable)
  • manufacturer’s name

Alternatively send the paper registration form(s) and cheque (made payable to ‘MHRA’) directly to:

Registration Scheme Officer
MHRA
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Make a change to your registration

You can tell MHRA about a change to a UK registration at any time.

Online registrations

You can make changes to your records via DORS when your account has been activated.

Paper registrations

Use form RG2 or RG3 depending on whether the registration was for a medical device or IVD to inform the MHRA of:

  • a change of address
  • addition of device types
  • a change in manufacturer name
  • a change of authorised representative
  • a change in status of an IVD, for example a change from ‘performance evaluation’ to ‘new’

You must pay £70 for each form you send requesting any changes.

You can make multiple changes on one form.

Quote MHRA registration reference number and date of the notification so that we can link the payment to the correct registration form(s).

If you are an overseas manufacturer and have appointed a new authorised representative in the EU you should send us a copy of a letter to your old representative that shows the date the service is due to end.

There is no need to inform MHRA if you decide to sell more products under a product code you have already registered for.

Register of manufacturers

Once registered, your company will be added to the Public Access Database for Medical Device Registration. Records are listed by manufacturer and device and include contact details. Manufacturers of in vitro diagnostic medical devices will not be published on this database.

Registration does not represent any form of accreditation, certification or approval.

Contact

If you are already registered with us, please contact us under the following alphabetical splits for your company name or the surname under which the registration is held:

  • A – D Jasu Patel on 020 3080 7195
  • E – M Barbara Clarke on 020 3080 7318
  • N – Z Angela Bartley on 020 3080 7149

Email: mb-mda-era@mhra.gsi.gov.uk