What is Article 15 MDR

Article 15 of the Medical Device Regulations (EU 2017/745) details that an organisation should have at least one person within their organisation who has expertise in the field of medical devices. This person is the referred to in article 15 as the Person Responsible for Regulatory Compliance (PRRC). A micro or small company does not have to employ this person, but may instead subcontract the role of the PRRC to an external company. The PRRC must ensure that: - the device is checked under the company quality management system, prior to being released in the market - technical documentation and the EU DoC is up to date - post market obligations are complied with - reporting obligations are fulfilled At Cranage Veritas, we have the appropriate professional expertise to be able to act as a PRRC for micro or small manufacturers to ensure compliance with Article 15 of the MDR (EU 2017/745). Get in touch with our team to discuss how we can help you

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