UK Medical Device Registration
The Digital Growth Charts API server and associated user interface libraries (together termed the RCPCH dGC Platform) are a Medical Device as determined under the Medical Devices Regulations 2002, Regulation 2 (1) "medical device" (a) (i) in that it "is intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease".
MHRA Medical Device Registration and GMDN Nomenclature
Determination of Medical Device Class¶
Determination of the class of medical device applicable was performed using the MHRA Medical Device Class tool on 7th May 2021 by Dr Marcus Baw, with reference to relevant supporting documents and legislation.
Post Market Surveillance¶
- User/API key registry enables communication with each implementer
- Forum
- Email list
UK Responsible Person¶
A UK Responsible Person is required only for manufacturers established outside the UK who wish to place a medical device on the Great Britain market. The RCPCH is established in the United Kingdom and therefore acts as the manufacturer, registering the device directly with the MHRA. A separate UK Responsible Person is not applicable.