The Regulations require manufacturers and authorised
representatives based in the UK to register with the Medical Devices Agency
details of themselves and the IVDs they are placing on the market.
The devices are required to be grouped together for registration
purposes, and this document describes how to complete the relevant parts of the
MDA registration form RG3. Guidance on all other aspects of RG3 can be found in
the MDA booklet "Guidance Notes for the Registration of Persons Responsible
for Placing in vitro Diagnostic Devices on the Market", available from MDA
at the address below.
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 available. In the interim, the system
generated by the European Diagnostic Manufacturers Association (EDMA) is to used
and copies of the relevant parts are attached. The full system may be downloaded
from the EDMA Web-Site at
http://www.edma-ivd.be/.
Further guidance may be obtained from:
Medical Devices Agency, Hannibal House, Elephant and Castle, London SE1
6TQ,
Telephone: 020 7972 8318
| Questions 6450 and 6550: Nomenclature system used |
Mark "EDMS" |
| Question 6465:
Group Code |
For reagents, reagent products, calibration and control
materials, you should identify the relevant analyte for each product, or group
of products, which you wish to register and enter its 8 digit code.
Alongside each group code, please enter the name of the corresponding analyte as listed in the "Reagent Classification" pages of the EDMA system. This will enable us to check on the validity of the code you have chosen when we transcribe it into MDA's database and subsequently transfer it to the European database |
| Question 6490: Short description |
If you cannot find the relevant analyte listed for any of your devices, please enter a short description here |
| Question 6565: Group Code |
For other IVDs, you should identify the relevant indication
from the "Instrument Classification Overview" pages of the EDMA system
for each product, or group of products (including accessories), you wish to
register and enter its 6 digit code.
Alongside each group code, please enter the name of the corresponding instrument grouping. This will enable us to check on the validity of the code you have chosen when we transcribe it into MDA's database and subsequently transfer it to the European database |
| Question 6590: Short description |
If you cannot find the relevant type of instrument listed for any of your devices, please enter a short description here. |
For Part 5, please continue until you have
entered all the analyte or instrument groupings covered by the devices which you
wish to register, photocopying the relevant blank page of the RG3 form if
necessary.
For Part 6, each individual product should
be notified separately, together with its relevant grouping, photocopying Part 6
so that each product is notified on a separate sheet.
Last updated : 18 May 2000