EUMDR introduces 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.
The medical device manufacturer who wishes to sell/ supply their device in European Union they must have at least one Person Responsible for Regulatory Compliance (PRRC) at their site of disposal.
Who can be PRRC and what are their Roles and responsibilities? What are the Roles of PRRC and Responsibilities of PRRC? Is that authorised representative requires PRRC?
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