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Roles of PRRC

Roles of PRRC

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Roles of PRRC

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  1. Roles of PRRC (Person Responsible for Regulatory Compliance) z Operon Strategist

  2. z EUMDRintroduces new requirements for the medical devices manufacturers, which explains the roles of PRRC. according to the new regulation of EUMDR, which came into force on 26 May 2021 the medical device manufacturer should have a PRRC to keep an eye on regulatory compliance. PRRC’s plays vital roles and responsibilities in setting up the plants for manufacturing medical devices. ▪ The PRRC’s are the authorized person who should have some specific qualification and experience .EU has published new rules and regulations for medical devices manufacturers that, these companies or organizations should have PRRC with them to look out the matter of regulations and policies PRRC is responsible for regulatory compliance Article 15(1) of MDR and IVDR has outlined some specific prerequisite for PRRC. ▪

  3. z What are the Roles of PRRC and Responsibilities of PRRC? The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. ▪ Keeping technical file and EC Declaration of conformity up to date. ▪ The compliance and effectiveness of internal process leading to product, ▪ Continuously monitor the Post market activities of medical devices, ▪ Reporting analysis of serious incidents, field safety corrective actions (FSCA), analysis of vigilance and trend reporting, ▪ PRRC shall inform the authorized representative, importer, distributor and notified body in case of any serious adverse action observe or occur, ▪

  4. z Appointment of PRRC Appointment of the PRRC is similar as you appoint your management representative. You have to create and sign the agreement with the PRRC, with the following information ▪ Purpose ▪ Scope ▪ Qualification requirement ▪ Roles of PRRC and responsibilities of PRRC ▪ Any additional Roles and responsibilities ▪ Date and signature of the PRRC and Company Head. ▪

  5. z Is that authorised representative requires PRRC? Yes, your authorisedrepresentative must have a PRRC permanently and continuously at their disposal. The PRRC shall possess the appropriate qualification and experience as discussed in point no. 01. ▪ Read More ▪

  6. Thank You. For More Information Contact Us www.operonstrategist.com info@operonstrategist.com +91-9325283428

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