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Reference Guide - GOV.UK

Crown Copyright 2022 \Device Registrations Reference Guide Please do not print this document. View online only to ensure you have the latest version. MHRA Device Registrations Reference Guide 1 | P a g e Version March 2022 v1 Contents Device Registration Reference Guide Logging in .. 2 Access MHRA Agency Services. 2 Username and Password 3 New Users > Change temporary password 3 Forgot password > resets 4 MHRA Agency Services 5 Enter Service 5 Organisations 6 Determine if your account is migrated or re-registered 7 Registering new devices .. 8 Add devices using GMDN 10 Upload Self-certification conformity declarations 12 Select from existing Self-certification conformity declarations 14 Upload Conformity Assessment Certificates (if applicable) 15 Select from existing Conformity Assessment Certificates 16 Adding products individually 17 Add products in bulk product template 20 Adding System or Procedure Packs (SPP) 27 Review information prior to making payment 32 Making Pay

MHRA Device Registrations Reference Guide 10 | P a g e Version October 2021 v1 Add devices using GMDN 1. Select the appropriate device type for the medical device to be registered. 2. Entering an appropriate word(s) into the ‘GMDN Code/Term’ text box will give you a shortlist of GMDN Terms to choose from.

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