Registration is a self-declaration process whereby manufacturers and their authorised representatives determine that their product falls within the definition of ‘medical device’ or ‘in vitro diagnostic medical device’, and that they have classified them as falling within Regulation 19/44 of the Medical Devices Regulations (SI 2002 No. 618) taking into account the intended purpose(s) and mode(s) of action.
Registration is stipulated in Article 14 of the Medical Devices Directive 93/42/EEC (external link).
In this section...
- Why register?
- Who should register?
- Is it a medical device?
- When to register
- Who to register with
- How to apply for registration
- How much it will cost
- What happens to your registration
- Changes to registered details
- The medical devices register
- European databank on medical devices
- Supporting documentation required to complete the processing of registrations
Why register?It is a legal requirement that manufacturers (or their authorised representatives or others) placing certain types of medical device or IVD medical devices on the EU market, provide certain information to a competent authority in a EU member state where they have a registered place of business.
Who should register?
You must register if you:
- manufacture class I or custom-made devices and place them on the market under your own name, or trading name(s)
- fully refurbish class I devices, or label one or more ready made devices, with a view to placing them on the market under your own name
- place 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
- sterilise, 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
- are the authorised representative of a manufacturer who does not have a registered place of business in the EU, or if you import and place on the EU market for a manufacturer who has no authorised representative in the EU, devices within the above listed categories.
- manufacture in vitro diagnostic medical devices (IVDs) and place them on the market under your own name, or trading name(s)
- manufacture IVDs for performance evaluation and make them available under your own name, or trading name(s)
- are the authorised representative of a manufacturer who does not have a registered place of business in the EU.
If you do not have a registered place of business in a EU member state you must designate a person established in the EU to act on your behalf.
Is it a medical device?
For a number of products it is not clear if they are medical device or not. The European Commission has a guidance document ‘Definitions of medical devices, accessory and manufacturer’ (MEDDEV 2.1/1) and below there are a number of examples (not an exhaustive list) of products that are generally not medical devices.
Toiletry and cosmetics products
- Tooth brushes, dental sticks, dental floss, un-medicated dental chewing gums
- Baby nappies, hygiene tampons, mattress protectors
- Contact lenses without corrective function intended to provide colour to the eyes (please note: contact lenses with corrective function, are classified as a class IIa medical device)
- Instruments for tattooing
- Deodorants for use with devices
- Hand cleansing wipes considered to be a cosmetic product.
Personal protective equipment
- Self rescue apparatus
- Ionising radiation protective clothing
- Eye protecting visors
- Protective gloves (e.g. for use in a medical laboratory)
- Wipes/swabs, brushes etc used to disinfect the skin of patients are usually
- regulated as medicinal products, and would be regulated by our Medicines
- Division of the MHRA.
- Wipe/swaps/brushes used by healthcare professionals to disinfect themselves
- (or other items not classified as medical devices), are usually regulated as
- biocides, and enforced by the Health and Safety Executive.
- Acoustic signals at traffic lights
- Breathalysers, other blood or air alcohol measuring devices
- Non sterile home, occupational, recreational protective/safety apparel
- Non prescription sunglasses
- Consumer products aimed at comfort
- Products for sport or leisure
- Surgical training kits/packs (kits/packs used for training only)
When to register
You must inform the competent authority when you first apply the CE marking to your device. If you have a number of models and the CE marking procedure is being introduced over a period, you may if you wish, inform the UK competent authority of all devices when informing of the first CE marking.
Manufacturers of custom-made devices, systems or procedure packs, and sterilisation companies, should register no later than the first time they claim compliance with the Directive.
Who to register with
If you are a registered business in the UK you may register with the UK competent authority (the MHRA). If you also have businesses in other member states of the EU, you may chose to inform one of them and not the UK, but you must inform one competent authority in which you have a registered place of business.
If your business is registered in another member state and not the UK you should seek information from the competent authority in that member state.
How to apply for registrationWe have two designated forms for registration:
These forms include guidance on how to complete them.
IVD product classification
These devices are required to be grouped together for registration purposes. Standardised groupings are required in order to facilitate the entry of, and access to, the registration data in the European databank. Therefore, each device grouping has a numerical group code so that the groupings can be entered and accessed in a systematic and consistent manner that is independent of language.
Either of the following nomenclatures can be used to register with the MHRA:
- the Global Medical Devices Nomenclature System. This can be accessed from the Global Medical Device Nomenclature (GMDN) website (external link)
- the European Diagnostic Manufacturers Association (EDMA). The full system may be downloaded from the EDMA website (external link).
How much it will cost
The current fee is £70.00 per registration or change of registration (under Regulation 53 of the Medical Devices Regulations SI 2002 No. 618).
You can register multiple devices on one form, by just copying additional pages when you run out of room.
The fee must be paid at the time of registering.
Send the registration form(s) and payment directly to:
Registration Scheme Officer, ERA2, Floor 4, 151 Buckingham Palace Road,
London, SW1W 9SZ or by email: firstname.lastname@example.org
Do not send forms to our finance department as this will delay the process.
Online by debit or credit card
This should be supported with enough information to allow us to link the payment to the correct registration form, especially if you submit multiple notifications. Ideally, you will quote the registration reference number and date of the notification.
If this is a new registration you will not have been assigned a reference number and so should provide the following:
- the type of form (RG2 or RG3)
- date of completing the form
- UK company name
- if you are an authorised representative, the company the registration is in respect of (iro). For example: RG2, 04/03/13, UK Devices Ltd iro USA Devices Inc.
For convenience you may scan and email the completed RG2/RG3 registration form (to email@example.com), but you must provide a copy of the online payment transaction receipt showing the date of payment, amount paid and the ID transaction number.
BACS/CHAPS: this should be supported with enough information to allow us to link the payment to the correct registration form, especially if you submit multiple notifications. Therefore please quote the payment transaction date and reference number on the registration form. Please also give the UK company name and (where different) the manufacturer name when making the BACS/CHAPS payment.
Our bank details can be found in the our bank account details section.
Cheque: Made payable to 'MHRA' and enclosed with your registration form. You may wish to consider sending paper form(s) and payment via a secure postal method, so that confirmation of receipt is recorded.
What happens to your registration
If you register in the UK, the MHRA will acknowledge your registration, allocate and inform you of your registration number, which you should quote in all subsequent correspondence. If we require any further information we will ask for it. There will be a single registration number, allocated for reference purposes only, covering all devices registered by the person responsible. It does not imply any form of approval by the competent authority.
Finally, relevant data on your devices will be entered into the European databank (Eudamed) in accordance with the directives (Article 12 of the IVD Directive; Article 14a of the Medical Devices Directive).
Changes to registered detailsAfter we register your notification, you must use form RG2 or RG3 to tell us about any changes or additions to the registered details. This incurs the same fee as the original registration (£70.00).
The following changes incur the fee:
- change of address
- addition of device types
- change of manufacturer name
- change of authorised representative
- change in status of an IVD e.g. change from ‘performance evaluation’ to ‘new’ or ‘other'.
There is no need to inform the MHRA of additional products being placed on the UK market if you have already registered under a generic code within which the new product falls. However, any products falling outside the generic codes registered i.e. an in vitro diagnostic and/or medical device(s) should be registered with the UK competent authority.
We may periodically review our records and request confirmation of the registered information.
The medical devices register
This is a database of registered devices, which is publically available on Public Access Database for Medical Device Registration website.
The information is held in alphabetical order by manufacturer name.To locate entries, go to the ‘Edit’ menu on your web page browser and use the ‘Find’ or ‘Find on this page…’ search function. This will only search individual pages of the register and not the entire database.
Companies registered as authorised representatives should note that information is published on our website under overseas company name with the UK name appearing beside these details.
European databank on medical devices – Eudamed
The aim of Eudamed is to strengthen market surveillance and transparency in the field of medical devices by providing member state competent authorities fast access to information on manufacturers and authorised representatives, on devices, certificates, vigilance and on clinical investigation data, as well as to contribute to a uniform application of the Directives, in particular in relation to registration requirements.
Further information relating to Eudamed is on the European Commission website (external link).
IVD registration: there is no longer a requirement for manufacturers and/or designated authorised representatives based in other EU member states to submit a notification to the UK competent authority under Article 10 of the In Vitro Diagnostic Medical Devices Directive 98/79/EC. Owing to the coming into force of the Commission decision concerning the implementation of the European databank (Eudamed), the MHRA no longer accepts nor acknowledges notifications submitted under the legislation quoted.
Supporting documentation required to complete the processing of registrations
Any manufacturer based outside the EU must designate an authorised representative (AR). The appointed AR must provide written evidence that they are acting with the consent of a manufacturer located outside the European Union. This may take the form of a letter of designation/contract from the overseas manufacturer.
Providing the following information upon submitting your form will enable us to process your registration faster:
Headed designation letter
The letter should state the full name and address of the AR and that they are the designated EU authorised representative based within the UK, under the Medical Devices Directive 93/42EC. In the case of a notification/registration for an in vitro diagnostic device please quote the Directive IVD Medical Devices Directive 98/79EC.
Headed cancellation/termination letter
In the case of an overseas manufacturer employing a new AR, the MHRA will require a copy of the letter from the overseas manufacturer, to the old AR terminating their services, and the date the service or contact is due to end.
Change of company name
So that we can establish whether the allocation of a new registration number is appropriate any registrations where there has been a change of company name, including becoming a limited company, will need confirmation in writing stating whether there has been or has not been a change in the legal entity of the business e.g. enough changes to the operations or structure of the company, as to be wholly different to the previous registration.
Guidance on the activity of operating as an authorised representative can be found in the European Commission’s ‘Guideline for authorised representatives’ MEDDEV 2.5/10.
Important note regarding the registration process
Once a valid notification form and payment have been submitted to us, there is no requirement for companies to wait for an acknowledgement letter from the MHRA before placing CE marked devices on the EU market.
In accepting a registration, the competent authority does not examine each individual notification and therefore cannot and does not necessarily endorse these determinations. Neither does the MHRA's registration letter represent any form of accreditation, certification or approval by the UK competent authority; it is just our acknowledgement that the registration process is at an end.
The MHRA does, however, reserve the right to take action against products placed on the UK market which are considered to be incorrectly CE marked, determined as an in vitro diagnostic device and/or classified as a medical device.
We have a frequently asked questions (FAQ) page, if you still have questions regarding the registration requirements.
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
or send your enquiry via email to: firstname.lastname@example.org.
You can also use this email address to give us feedback on our guidance and how it is presented.