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
The RCPCH Digital Growth Charts API is registered with the MHRA as a Class I medical device, with the GMDN Identifier of 65712 - Paediatric growth calculation API software
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.
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