European Parliament Approves Medical Device Directives

Paving the way for improvements in medical device regulation in the European Union, the European Parliament adopted more than 100 amendments to medical device directives.

Among the 141 amendments approved were clarifications on the use of software in medical products, stricter labeling requirements for devices that potentially leach phthalates into the patient’s body and pressures on devicemakers to replace high-risk materials with alternative substances and to avoid the use of substances that cause cancer, mutations or reproductive toxicity.

The amendments package, which revises the European Commission’s original 2005 proposal, is expected to be adopted quickly.