Registration of medical devices

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 with the MHRA details of themselves and the medical devices they are placing on the market. 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 (211Kb)
• Appendix A and Appendix B (67Kb)
• Registration Form RG2 (100Kb)

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 (345Kb)
• Opticians/Glazing Laboratories

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 market.

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 (181Kb)
• 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 (185Kb)
• In-Vitro Diagnostic Medical Devices Directive 98/79/EC - Guidance Note 19 (289Kb)

Providing the following information upon submitting your form, will enable us to process your registration faster:

Cost per registration
There is a statutory fee of £70.00 for new or subsequent changes to the registration details held with the MHRA. Payment can be made by cheques payable to "MHRA" or by BACS/CHAPS. At present we do not have the facilities to accept payments via credit/debit cards.

If a payment is submitted via BACS/CHAPS you will need to quote the invoice number that your payment relates to, and your customer account number. You can locate both the invoice number and customer account number on the invoice issued by the MHRA. Please note, quoting this information will enable our Finance section to allocate your payment to the correct transaction.

BACS payments
Bank Name: Bank of England
Address: Government Counter, Threadneedle Street, London, EC2R 8AH
Sort Code: 10:14:99
Acc No: 06781000
Reference: Invoice Number and Customer Account Number (please ensure this is quoted on transfer)

Sterling CHAPS payments from a UK account
Bank Name: Natwest Bank
Address: 6 Coldharbour Lane, Hayes, Middlesex, UB3 3EL
Sort Code: 16:53:60
Acc No: 6781
Reference: Invoice Number and Customer Account Number (please ensure this is quoted on transfer)

For EURO currency payments from a Member State
Account Name: Office of the Paymaster General - EURO Receipts
Address: Natwest, 6 Coldharbour Lane, Hayes, Middlesex, UB3 3EL
Sort Code: 60:10:43
Acc No: 55001008304793
Swift Code: NWBKGB2L
Reference: Invoice Number and Customer Account Number (please ensure this is quoted on transfer)
IBAN: GB43NWBK60720608304793, OPG EURO Receipts Account

For Sterling currency payments from an Overseas Account
Account name:   Office of HM Paymaster General - Euro Receipts
Account number:  41414985
Sort Code:  60  10  43
Swift Code:  NWBKGB2L
Reference: Invoice Number and Customer Account Number (please ensure this is quoted on transfer)
IBAN:   GB82NWBK60104341414985
    OPG Euro Receipts Account
Branch Address:  
    Natwest Bank
    6 Coldharbour Lane
    Hayes
    Middlesex UB3 3EL

For all Overseas Transfers
Account name: Office of the Paymaster General - Cash a/c
Address: Bank of England, Government Counter, Threadneedle Street, London, EC2R 8AH
Sort Code: 10:00:00
Acc No: 25021001
Swift Code: BKENGB33
Reference: Invoice Number and Customer Account Number (please ensure this is quoted on transfer)
IBAN: GB57BKEN10000025021001

Authorised Representative
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.

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.

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 e.g. enough changes to the operations/structure of the company, as to be wholly different to the previous registration.