MHRA Issues Draft Guidance On Re-Manufacturing Single-Use Devices

By Jof Enriquez,
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The Medicine and Healthcare Products Regulatory Agency (MHRA) has released draft guidance on the re-manufacturing of single-use devices (SUDs) in the United Kingdom. The UK regulator is accepting public comments for review until Sept. 1, 2015, and final guidance will be available by the end of 2015.

In a news release, the MHRA says the draft guidance is a product of a two-year, detailed review of the technical, regulatory, and clinical processes conducted by European re-manufacturers of SUD products, which are entering the UK market in increasing numbers. The document is made for manufacturers and providers of medical devices, healthcare professionals, and executives of organizations where medical devices are used.

The draft guidance, entitled "Single-use medical devices: UK guidance on re-manufacturing,” allows the use of re-manufactured SUDs in the UK. However, it requires that re-manufacturers must:

• Meet all appropriate criteria of the relevant Medical Devices Directive in terms of performance and safety
• Place a CE mark on the product
• Confirm validity and surety of all re-manufacturing processes
• Meet post-market surveillance requirements, and
• Accept all liabilities and obligations for the SUD.

The document states that Class I medical devices should not be re-manufactured as "there would be no external or independent assessment of CE-mark compliance."

SUDs should be re-manufactured by the same company (each time), which has to validate a limited number of re-manufacturing cycles a product should undergo. If the pre-determined limit is reached, or if the device fails safety and performance tests during any re-manufacturing cycle, the company is required to dispose the product.

The re-manufacturer should retain identifiers put in place by the original equipment manufacturer (OEM), then add their own identifiers, including their company name, address, and serial number. Packages should clearly state that the product has been re-manufactured from the original, and be marked with a designated "do not reuse/use only once/single-use" symbol. A re-manufactured SUD should be used on an individual patient during a single procedure only.

According to the draft guidance, "anyone who re-manufactures a single-use device has the same legal responsibility for it as the original manufacturer." However, "after the first use of the single-use device, the original equipment manufacturer (OEM) is no longer responsible for the product if it is not disposed of."

Healthcare facilities are required to return an SUD they want re-manufactured to the same re-manufacturing company to which they are under contract. When these devices are placed in the re-manufacturer's bins at the healthcare facility, the responsibility for the device transfers to the re-manufacturer.

The MHRA says it will update the guidance following a review of comments and changes under pending EU legislation concerning medical device regulation. In its draft guidance, the MHRA allows re-manufactured SUDs, but advises against reprocessing said devices. Pending proposals by the European Council, Parliament and Commission rules may permit re-processing of devices depending on national laws of EU member states.

According to RAPS, under consideration is whether the EU "would consider reprocessors to be the manufacturer of a device, taking on all responsibilities of the original device maker, and require reprocessors to ensure that reprocessed devices are equivalent to the original device in terms of safety and specification. The proposal would require the EC to establish a list of device categories that are not suitable for reprocessing."