Registration of medical devices

Access to Medical Devices Register
Information on the registration of persons responsible for placing devices on the market in accordance with Article 14 under the Medical Devices Directive 93/42/EEC is now available. This includes UK based manufacturers or representatives for class I and custom made devices as well as for assemblers of systems and procedure packs.

Information on the registration of persons responsible for placing devices on the market

Medical Device Regulations 2002: Regulations 19 and 44 registration of persons placing general medical devices and/or in vitro diagnostic medical devices on the market
In March 2009 the MHRA wrote to all UK manufacturers and authorised representatives that are registered with the Agency for placing medical devices on the EU market.

The purpose of this letter was to inform registered companies that the MHRA will no longer be able to treat information provided for registration purposes as confidential and it may be released to the public from 21 March 2010.

In order to ensure that the information released from March 2010 is current, the MHRA requested in their letter that registrants confirm that they wish to remain on the register and that their current details are correct or require updating.

Companies were asked to complete one of the following actions as necessary.

1. Where they needed to remain registered with the MHRA and their details have not changed, they were asked to send an email to MHRA to confirm this quoting the registration number. There is no £70 fee required in this case.
2. Where they needed to remain registered with the MHRA and their details did require updating (ie there has been a change in company name or address or the device categories being placing on the market) they were asked to complete a new RG2 or RG3 form with their amended details and submit this to the address at the bottom of the first page of the form with the £70 registration fee.
3. Where they no longer place medical devices or IVDs on the market and therefore no longer need to be registered with MHRA they were asked to send an email to MHRA to confirm this quoting their registration number. There is no £70 fee required in this case.

Where a response to this letter was not received by 31 May 2009 the relevant registration will have been archived. The companies concerned are therefore no longer registered and will not be complying with the legal requirements. Registrations were also archived for all letters returned to the MHRA undelivered.

If you are concerned that your registration has been archived, please contact us under the following alphabetical splits for your company name or the surname the registration is held under:

A – D = Jasu Patel 020 3080 7195
E – M = Barbara Clarke 020 3080 7318
N – Z = Angela Bartley 020 3080 7149
or send your enquiry via email to: ERA@mhra.gsi.gov.uk

Changes to the Medical Devices Regulations
Directive 2007/47/EC amends the Active Implantable Medical Devices Directive 90/385/EC and came into force on 21 December 2008. One change to the directive especially affects persons responsible for placing and putting into service custom-made active implantable medical device(s) on the EU market.

Article 1.11 of Directive 2007/47/EC amends Article 10 of Directive 90/385/EC to include a requirement for manufacturers of custom-made active implantable medical devices to provide the Competent Authority of the member state in which they have their registered place of business details of their address, a description of the device(s) concerned, the product labelling and the instructions for use.

The revisions to the directives have been transposed into UK law, under the Medical Devices (Amendment) Regulations 2008, and came into force on 21 December 2008. However the regulations only become mandatory on 21 March 2010.

Medical Devices Directive
The regulations require manufacturers and authorised representatives based in the UK who are placing class I or custom-made devices to register details of themselves and the medical devices they are placing on the market with the MHRA. This also applies to products covered by Article 12 of the directive including sterilizers and people carrying out assembly. Guidance for opticians and glazing shops is available under Ophthalmic products.

Guidance
The following guidance has been produced by the MHRA to assist with the registration process:

• Guidance Note 8 - Guidance Notes for the registration of persons responsible for placing devices on the market (64Kb)
• MHRA list of generic code names for the RG2 form - Appendix A and Appendix B (65Kb)
• Registration form RG2 (275Kb)

Additional information for class I, system and procedure packs and custom made medical devices can be obtained via:

• Manufacturers of Class I medical devices - Guidance Note 7 (118Kb)
• Manufacturers of custom-made medical devices - Guidance Note 9 (283Kb)
• Dental laboratories - Guidance Note 10 (113Kb)
• Manufacturers of orthopaedic and prosthesis medical devices - Guidance Note 16 (305Kb)
• Opticians/glazing laboratories

Custom-made medical devices
Changes to the Medical Devices Directive were transposed into UK law by the Medical Devices Amendment Regulations SI 2008 No 2936 (external link). There is one key change relevant to manufacturers of custom-made devices. The amended Regulations require that the 'statement' which accompanies the device should be available to the named patient for whom the device has been manufactured. Guidance on the statement has been drafted by the MHRA in consultation with interested parties.

Guidance to Changes to the Medical Devices Directive 93/42/EC with respect to custom-made devices statements (371Kb)

Information regarding In Vitro Diagnostic Directive (IVDD) 98/79EC notifications for IVD device registrations under Article 10 submitted with other EU Member States
Please note there is no longer a requirement for manufacturers and/or designated authorised representatives based in other EU members states to submit a notification to the UK competent authority under Article 10 of the In Vitro Diagnostic Directive (IVDD) 98/79EC. Owing to the coming into force of the Commission decision concerning the implementation of the European Databank called Eudamed, the MHRA no longer accepts these notifications nor will we acknowledge notifications submitted under the legislation quoted.

This decision mandates each member state to forward certain medical devices information to the European databank collected in each country where the manufacturer or the authorised representative (AR) is located. Therefore the implementation of Eudamed, the transitional provision in Article 12 of IVDD 98/79/EC, which obliges IVD manufacturers to give notification to every Member State concerned by the placing on the market of IVD devices, ceases to apply.

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 the information contained on Eudamed can be obtained from the European Commission (external link).

In Vitro Diagnostic Medical Devices Directive
The regulations require manufacturers and authorised representatives based in the UK to register with the MHRA details of themselves and the IVDs they are placing on the EU market. This includes IVDs undergoing performance evaluation in one or more member states (see Guidance Notes 18 and 19 below).

The EDMA IVD product classification system
The 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 database. Therefore, each device grouping has a numerical group code so that the groupings can be entered and accessed in a systematic and consistent manner which is independent of language.

It is intended by Member States that groupings from the Global Medical Devices Nomenclature System be used when the European database comes into operation. In the interim, the system generated by the European Diagnostic Manufacturers Association (EDMA) is to be used. The full system may be downloaded from the EDMA website (external link).

Guidance
The following guidance has been produced by the MHRA to assist with the registration process.

• Guidance Note 18 - Guidance Notes for the registration of persons responsible for placing in vitro diagnostic medical devices on the market (226Kb) 
• Registration Form RG3 (256Kb)
• Group codes for IVD registration (82Kb)

Additional information for in vitro diagnostic medical devices can be obtained via:

• Sale and Supply of In Vitro Diagnostic devices - Bulletin 12 (122Kb)
• In Vitro Diagnostic Medical Devices Directive 98/79/EC - Guidance Note 19 (320Kb)

Cost per registration
Under Regulation 53 of the Medical Devices Regulations (SI 2002 No 0618) (external link) there is a £70.00 statutory fee payable for new or subsequent changes to the registration details held with the MHRA. Please also note the fee is payable per form submitted and should accompany the form. The MHRA is unable to process registration forms until payment of the fee has been received.

The fee should be paid at the time of registering. Registration forms and payment should be sent directly to the Registration Scheme Officer - ERA2, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ. This will allow us to process your registration immediately upon receipt and reduce the need to confirm submission of your payment via our corporate finance department.

Payment can be provided via the following methods
Cheque: Made payable to 'MHRA' and enclosed with your registration form.

BACS/CHAPS: Payment submitted via BACS/CHAPS 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.

Bank Branch Address:
Our bank account details

Credit Card: Payments for registrations can now be submitted using credit card:

Debit or credit card payment form

Payment submitted via credit card should be supported with enough information to allow us to link the payment to the correct registration form, especially if you submit multiply 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 credit card payment.

Authorised representative (AR)
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 Community. 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 MDD 93/42EC. In the case of a notification/registration for an in vitro diagnostic device please quote the Directive IVDD 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/contact is due to end.

Change of circumstance (COC)
So that we can establish whether the allocation of a new registration number is appropriate any registration where there has been a change of company name, or become a limited company; please provide written confirmation stating whether there has been/has not been a change in the legal entity of the business, eg enough changes to the operations/structure of the company, as to be wholly different to the previous registration.