Changes to the Registration of Medical Devices

Please note the following changes to the registration of medical devices under Article 14 of Directive 93/42/EEC as implemented by Regulation 19 and 53 and 60 of the Medical Devices Regulation 2002 (SI 2002 No 618):

1. There is a charge of £70 per registration or change of registration. The regulations require this fee to accompany the information when it is sent to the MHRA.

2. Authorised representatives are required to provide evidence that they are the authorised representative of the manufacturer on whose behalf they are claiming to make the registration. This may take the form of a letter of designation from the manufacturer.

Registration forms RG2 (for medical devices) and RG3 (for in vitro diagnostic medical devices), together with guidance on their completion, are obtainable from:

The Registration Scheme Officer, MHRA, 8th Floor, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

Or:

Telephone: 020 7084 3318