PRRC support in accordance with Article 15 of the EU MDR/IVDR, where applicable and subject to formal engagement and eligibility requirements.
The Person Responsible for Regulatory Compliance plays a defined role in supporting regulatory oversight under the EU MDR and IVDR. DnA provides External PRRC Support for eligible organisations, helping maintain regulatory responsibilities and appropriate compliance oversight throughout the engagement.
Supporting eligible organisations requiring an external PRRC arrangement
Providing PRRC support in accordance with Article 15 of the EU MDR/IVDR
Reviewing relevant regulatory and quality documentation within the PRRC scope
Supporting ongoing regulatory compliance responsibilities under the agreed engagement
Provide External PRRC Support in accordance with applicable Article 15 requirements, subject to eligibility and a formal engagement.
Support oversight of applicable regulatory and quality activities within the defined PRRC responsibilities and agreed scope.
Review relevant compliance documentation and records required to support PRRC responsibilities throughout the engagement.
External PRRC Support is an ongoing responsibility rather than a one-time documentation exercise. DnA Regulatory Solutions works within the formally agreed scope to support appropriate regulatory oversight and help ensure relevant compliance responsibilities continue to receive attention.
Maintain oversight within the defined PRRC engagement and responsibilities
Review relevant regulatory documentation and compliance activities
Support ongoing communication and regulatory follow-up where applicable
Defined Scope. Responsible Oversight:
DnA provides External PRRC Support in accordance with Article 15 of the EU MDR/IVDR, where applicable. Engagement is subject to eligibility requirements and a formally agreed scope of responsibilities.
External PRRC Support provides eligible organisations with access to a Person Responsible for Regulatory Compliance in accordance with applicable Article 15 requirements of the EU MDR/IVDR.
Not necessarily. External PRRC arrangements are subject to applicable regulatory requirements, organisational eligibility and formal engagement. The appropriate arrangement should therefore be assessed before support begins.
Support is provided within the formally agreed PRRC scope and may involve applicable regulatory oversight, review of relevant documentation and ongoing compliance responsibilities.
Access structured PRRC support aligned with applicable EU MDR/IVDR Article 15 requirements and a clearly defined scope of responsibility.