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European Medical Device Regulations Tightened Due to Metal-on-Metal Hip Implant Safety Concerns

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 ... Read More