The Commission proposed to update the rules - April 5th 2017
Last week the European Commission issued a press release in which it suggests new EU rules concerning the safety of medical devices. Since the last harmonization occurred in the 90’s, today’s regulations do not reflect the tremendous evolution in this sector. By moving forward, the aim of the Commission is to set a new global gold standard.
The rule covers all medical devices, in vitro diagnostic medical devices, certain contact lenses, and equipment for liposuction. The Commission expects that the introduction of this new regulation will simplify administrative procedures, expand legal certainty, and increase credibility and reputation of the overall EU medical device system.
The full press release is available here: http://europa.eu/rapid/press-release_MEMO-17-848_en.htm
For questions or discussions around your medical device needs, get in touch with Systec & Services Domain Experts: http://www.systec-services.com/en/contact/contact-form/
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