Beginning Sept. 1, companies that put their names on devices made by other companies must have their quality management systems (QMS) audited and full technical documentation reviewed by notified bodies, says new guidance from the UK’s MHRA.
Previously, notified bodies accepted summaries of technical documentation from “virtual manufacturers” and did not require full QMS audits. However, under new Medicines & Healthcare products Regulatory Agency (MHRA) guidance, a company that outsources the design and manufacture of a device must keep the full technical documentation available and submit to audits if the product is marketed under the company’s name.
Technical documentation must show that a marketed device meets regulation requirements. It also must be fully integrated into a firm’s QMS and contain all relevant data pertaining to labels, instructions for use, and risk assessments.
If a virtual manufacturer does not hold the rights to a product’s design, it may provide a technical file with redacted proprietary information. However, the OEM must agree to fully disclose all technical information directly to the appropriate notified body, as well as submit to unannounced audits, post-market surveillance, and other requirements.