New medical device regulations (MDR) have been put in place by European Parliament after four years of negotiation. The decision to tighten regulation was spurred by safety concerns over breast implants and metal-on-metal hips.
The regulation amendments are expected to begin in early 2017, and medtechs will be allowed three years to comply. If the medical products fail to meet the new regulation standards, the manufacturer will lose their CE rating, which allows legal marketing of the product.
The new regulations include stricter rules regarding clinical trials, quality management, and marketing necessities such as product labeling and design. Regulators will now inspect Class III devices, such as hip implants, more critically than Class I products, such as sutures. Medical device manufacturers are now required to collect clinical data to track the performance of the product and make improvements where needed.
Manufacturers are expressing frustration over the increased cost associated with stricter MDR, but regulators are making no exceptions. This seems to be a necessary implementation in light of recent controversy and lawsuits regarding metal-on-metal hip implants.
Metal-on-metal hip implant manufacturers such as Wright Medical, DePuy Orthopaedics and its parent company Johnson & Johnson, Stryker, Smith & Nephew and Zimmer Biomet Holdings have been facing an avalanche of lawsuits in recent years for their allegedly failed hip implant designs.
The metal-on-metal design results in metal particles flaking off as the parts rub together with normal use. The patients have complained of loosening and excruciating pain. Many have experienced damage and inflammation to the surrounding tissue. The metal toxicity in the blood stream has also been linked to cobalt poisoning, with resulting symptoms such as tremor, poor coordination, cognitive decline and depression, as well as heart, hearing and vision damage.