As part of Navigate, MedRAS provides Responsible Person services. Under the UK MDR 2002, non-Great Britain based manufacturers must appoint a UK based responsible person who is required to undertake a number of critical regulatory functions on behalf of, and in conjunction with the legal manufacturer. Similar requirements apply to manufacturers marketing medical devices under the EU Medical Device Regulations (EU) 2017/745.
These are critical regulatory roles which require manufacturers to ensure they assign this responsibility to on-hand, qualified, and competent personnel. MedRAS has implemented processes to provide Responsible person services and holds the required experience, and competence to fulfil these roles fully in-house.
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Service feature | Inclusion |
Monthly compliance verification and provision of monthly status update | |
Technical documentation and declaration of conformity initial audit and review | |
Technical documentation and declaration of conformity secure retention | |
Labelling compliance review and Inclusion of MedRAS UKRP on medical device labelling | |
Completion of the MHRA registration and ongoing maintenance | |
Monitoring and surveillance of complaints and vigilance reports | |
24/7 monitored UKRP mailbox | |
Provision of adhoc support via Navigate consultancy service |
Service feature | Inclusion |
Monthly compliance verification and provision of monthly status update | |
Technical documentation and declaration of conformity initial audit and review | |
Technical documentation and declaration of conformity secure retention | |
Labelling compliance review | |
Completion of Eudamed registration and ongoing maintenance | |
Monitoring and surveillance of complaints and vigilance reports | |
24/7 monitored PRRC mailbox | |
Provision of adhoc support via Navigate consultancy service |
Company number: 14185746