Register a manufacturer or authorised representative (agent) for a manufacturer, to sell medical devices, including in vitro diagnostic (IVD) medical devices.
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
- in vitro diagnostic medical devices (IVDs) undergoing performance evaluation
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
Examples of products that are not medical devices include:
- 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
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:
- the Global Medical Devices Nomenclature System
- the European Diagnostic Manufacturers Association (EDMA)
If you manufacture IVD medical devices that are then sold (either by you or another company) you will need to register using the device online registration system (DORS).
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 in section 2.5 of Guidance MEDDEVs on the European Commissions website.
Apply to 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.
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.
You must pay £70 via DORS per registration.
Make a change to your registration
You can tell MHRA about a change to a UK registration at any time and/ or make changes to your records via DORS once your account is activated.
You must inform 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’
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.
You must pay £70 for each change request.
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.
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