The QMN Weekly Bulletin

MHRA Issues Draft Guidance Outlining Remanufacture of Single-Use Devices

Sept. 11, 2015

The UK’s Medicines and Healthcare products Regulatory Agency is advising companies that remanufacture single-use medical devices that they are subject to the same adverse event reporting requirements as original equipment manufacturers.

The requirement is part of draft guidance published July 20, which takes into account a two-year review that assessed manufacturers’ technical, regulatory and clinical processes. Companies have indicated to the MHRA that they want to put their products on the UK market, as the remanufacturing process has been utilized in other countries for a number of years.

Among other things, the agency wants remanufacturers to demonstrate that their products meet all appropriate criteria of the relevant medical devices directive in terms of performance and safety. A refurbished device’s labeling must state that the device is remanufactured and include the OEM’s name and product serial number. Remanufacturers also should demonstrate compliance with ISO 14971 — Risk management for medical devices — to identify all possible risks and mitigation strategies for the device.

Remanufacturers also must continuously monitor for any changes the OEM makes to the product, the guidance says. Suggested tactics include:

  • Continuous market observations or safety information published by the OEM;
  • FDA approvals or safety information;
  • Safety information from competent authorities;
  • Information from end users;
  • Incoming goods inspection for all devices;
  • Electrical, material, performance and safety assessments conducted on all devices during remanufacturing; and
  • Manufacturing and outgoing goods inspections for all devices.

Remanufacturers also are responsible for managing any product safety notification or recall an OEM has implemented that affects one of their devices, the MHRA says.

If the device fails to meet safety and efficacy expectations, or there is an indication that the product has been remanufactured or reprocessed at a different facility, the company must dispose of that item, according to the draft document. Remanufacturers also are responsible for keeping track of how many times a device is refurbished and reused.

Remanufacturers should have technical documents on hand to show their device conforms to the requirements of the relevant directive. This documentation should be on file for at least five years, or 15 years after the last product was placed on the market for an implantable device.

Remanufacturers of single-use devices, providers of medical devices, CEOs and managers of organizations where these devices may be used and healthcare professionals are encouraged to participate in a survey posted on the MHRA’s website. The agency accepted feedback until Sept. 1, 2015. Final guidance is expected by the end of the year.

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