Please note that the above Regulations make the following changes
to the registration of medical devices under Article 14 of Directive 93/42/EEC
as implemented by Regulation 14 of the Medical Devices Regulations 1994:
1.
There will be a charge of £70 per registration or change of registration.
The regulations require this fee to accompany the information when it is sent to
MDA
2. Authorised representatives are required to provide evidence that
they are the authorised representative of the manufacture 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, Medical Devices Agency, Hannibal House, Elephant
and Castle, London SE1 6TQ.
Or:
Telephone: 020 7972 8318
Last updated : 18 May 2000