Skip to content

Pelvic Mesh: The Obligations of Medical Device Manufacturers Under the CPA

An explanation of the obligations a Medical Device Manufacturer has in relation to manufacturer liability as provided for in the Consumer Protection Act.

The Consumer Protection Act 68 of 2008 (“the CPA”) is South African legislation enacted to protect consumers by affording them specific rights and placing specific duties on, amongst others, manufacturers, importers, and suppliers of goods.

In terms of section 55 of the CPA, consumers have the right to safe and good quality goods, including medical devices. This places certain duties on medical device manufacturers (including producers, importers, distributors, marketers or suppliers) to meet those consumer rights.

A medical device manufacturer has a duty to provide medical devices that are suitable for the purpose for which the manufacturer intended; are of good quality, in good working order and do not have any defects; and can be used or will last for a reasonable period of time.

If any harm is caused to a person as a result of a defective medical device, the manufacturer of such device may be held responsible without having to show that the Manufacturer’s conduct was negligent. This concept is known as “strict liability”.

The different instances in which a medical device manufacturer may be held strictly liable can be found in section 61 of the CPA. These instances include harm caused as a result of supplying medical devices that are unsafe, defective or dangerous for a consumer to use; the failure of any medical device; or inadequate instructions or warnings given to the consumer regarding any hazard that could arise by using the medical device.

Persons who suffered harm as a result of defective medical devices may therefore have a claim against the manufacturer thereof in terms of the CPA.

Leave a Comment