MHRA & Med Devices RO requirement after Jan 1 2021

If by RP you mean Responsible person as is defined in MDR 2017/745  Article 15 and  Article 16, Advisera can offer you the following documentation templates that cover the post-market surveillance system:

• Procedure for Post-Market Surveillance System https://advisera.com/13485academy/documentation/procedure-for-post-market-surveilance/
• Post-Market Surveillance Plan https://advisera.com/13485academy/documentation/post-market-surveilance-plan/
• Post-Market Surveillance Report https://advisera.com/13485academy/documentation/post-market-surveilance-report/
• Periodic-safety update report https://advisera.com/13485academy/documentation/periodic-safety-update-report/

In the Procedure for Post-Market Surveillance System is described who can be and what are the responsibilities of the Person for regulatory requirements.

For more information, see:

• Article 15 – Person responsible for regulatory compliance https://advisera.com/13485academy/mdr/person-responsible-for-regulatory-compliance/
• Article 16 – Cases in which obligations of manufacturers apply to importers, distributors or other persons https://advisera.com/13485academy/mdr/cases-in-which-obligations-of-manufacturers-apply-to-importers-distributors-or-other-persons/