Medtech Companies Could Face Sanctions As Italy Enforces Own Advertising Rules Under MDR
Italy is applying medtech advertising rules that are stricter than those of its fellow EU members. The situation looks likely to persist, and companies could face sanctions if they contravene Italy’s laws until the courts review this European anomaly.
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EU member states need to decide some aspects of the EU’s medical device regulations, such as their competent authority and labeling language, for themselves. Here Italy explains its position.
The call for more to be done about the EU’s regulatory hurdles to innovation, as well as for improvements to governance, has now grown to a crescendo. While the EU looks at how best to move forward, innovation in the UK is benefiting from greater regulatory freedoms.
The revised timelines around products generally used for aesthetic purposes, a small subset of products falling under the Medical Device Regulation, create their own microsphere of complexity.