Module 17 2024

Howard Dobbs

04/12/2024

MHRA Guidance, January 2021 Section 5: Technical documentation

• The VM is expected to hold full technical documentation …

• The technical documentation should be fully integrated into the manufacturer’s QMS where applicable and should contain data relevant to the manufacturer (e.g. labels, instructions for use, risk assessment, etc.) • Proprietary information within the technical documentation can be redacted as long as the redacted information is not essential for assessing whether the device complies with the regulatory requirements - but see next slide

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

39

MHRA Guidance, January 2021 Section 6: The contract

• The VM must ensure that an appropriate contract is in place with the OEM. • The contract must include: - a list of the VM’s devices and cross - reference to OEM’s devices - arrangements for PMS, Vigilance Reporting and PMCF - arrangements for change control - provisions for unannounced audits of the OEM and other critical suppliers - supply of the OEM’s fully un-redacted information upon a request from the VM’s NB - supply of the OEM’s current UK CA/EU NB certificates - supply of evidence of the OEM’s registration with their regulator/competent authority

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

40

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