5/30/07
The European Parliament adopted more than 100 amendments to medical device directives that should pave the way for improved device regulation in the European Union.
The parliament approved 141 amendments, including clarifications on the use of software in medical products, and stricter labeling requirements for devices that potentially leach phthalates into the patient’s body.
There will also be increased pressure on devicemakers to replace high-risk materials with alternative substances and to avoid the use of substances that cause cancer, mutations, or reproductive toxicity.
