Navigate - UKRP / PRRC

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.


Get in touch to see how we can support your organisation’s next project.


UK RESPONSIBLE PERSON- UK MDR 2002: SERVICE FEATURES

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


Person RESPONSIBLE for regulatory compliance- (EU) 2017/745: SERVICE FEATURES

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



Appointing a UK Responsible person is easy and begins with getting in touch:

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