Industry and doctors warn: niche product • Table.Briefings

Medical professionals and Medtech manufacturers are sounding the alarm. Many medical devices for rare diseases could disappear from the market due to the stringent requirements of the new EU Medical Devices Regulation – at the expense of patients. Surgical instruments and implants for children appear to be particularly affected.

The Association for European Paediatric and Congenital Cardiology (AEPC) has informed them of an impending shortage of medical devices for pediatric cardiac interventions, writes Dutch MEP Kathleen van Brempt (S&D) in her parliamentary question to the Commission. This shortcoming is said to be a consequence of the EU Medical Devices Regulation (MDR). Whether the Commission is aware of this problem and whether it plans to revise the MDR, van Brempt asks.

Industry and doctors warn: niche products disappear from the market

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