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New EU medical device regulation expands product coverage and requires significantly more monitoring

The European Union will apply new regulations to the medical device sector in May 2020 under the EU Medical Device Regulation (MDR), a sweeping overhaul of the Medical Device Directive, which had been the regulatory standard in Europe since 1992. The MDR significantly tightens and increases pre- and post-market obligations for economic operators (i.e., manufacturers, distributors, importers, suppliers, subcontractors, assemblers and EU Authorized Representatives), establishes a database for all covered devices, and significantly expands the scope of covered devices and substances.

According to Travis Miller, general counsel at Assent Compliance, key objectives of the new regulation are:

  • “Stricter lifecycle control of medical devices through enhanced quality management systems and the introduction of a Unique Device Identification (UDI) and a database

  • “Introduction of a new risk classification system for in vitro diagnostic medical devices

  • “Introduction of an implant card containing information about implanted devices for the patient

  • “Improved coordination between EU Member States in the fields of vigilance and market surveillance

  • “Increased oversight of Notified Bodies”

Medical device supply chains will see a dramatic increase in their regulatory burden through reporting, analysis of components and substances, and training and education in order to comply with the MDR. The EU has published guidance, including a step-by-step process for complying with the new regulations that is available for free.

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