Guidance on PRRC Article 15 MDR

As detailed in Article 15 of the MDR (EU 2017/745), a company must have a Person Responsible for Regulatory Compliance (PRRC) at their disposal at all times. For a small or micro manufacturer, the role of the PRRC may be subcontracted to an external party. Cranage Veritas can act as a PRRC on behalf of your company. Some of the duties of the PRRC include: - ensuring the device conforms to the manufacturer's quality management system - maintaining the technical documentation and the EU Declaration of Conformity - ensuring compliance with post market obligations. Get in touch with the team at Cranage Veritas to discuss how we can help you achieve compliance to the Medical Device Regulations (EU 2017/745).

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