Medicines and Healthcare products Regulatory Agency (MHRA) – Notice of No Objection (Medical Device Research)

Under the Medical Devices Regulations 2002, the manufacturer must obtain a Notice of No Objection from the Medicines and Healthcare products Regulatory Agency (MHRA) as well as ethical approval from a REC to conduct a clinical investigation of a medical device for CE-marking purposes.

Applications to the MHRA for a Notice of No Objection are made up of PCA1 and PCA2 forms and Sterilisation Annex (where applicable); these are prepared in the Integrated Research Application System (IRAS) as a single collated application form for MHRA Devices. This application form must be submitted to MHRA on disk along with all necessary supporting documentation and payment of application fee.