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MDR Regulations-Impact on Medical Devices

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  1. Increased regulatory requirements: The EU MDR imposes stricter regulations for medical devices, including more rigorous clinical evidence requirements, stricter rules on post-market surveillance, and increased oversight by notified bodies.
  2. Higher compliance costs: Compliance with the new regulations is costly, and companies must invest in new technology, personnel, and training to comply with the MDR.
  3. Longer product development timelines: With more stringent regulations, it takes longer for medical devices to obtain regulatory approval, which can delay product launches and increase development costs.
  4. Fewer available notified bodies: The EU MDR requires that medical device manufacturer’s work with a notified body for certification, but many notified bodies have dropped out of the program, leaving fewer options for manufacturers.
  5. Increased transparency: The EU MDR requires manufacturers to provide more information on their products, including detailed product information, clinical data, and post-market surveillance reports.
  6. Impact on non-EU manufacturers: The EU MDR affects not only EU-based manufacturers, but also manufacturers based outside of the EU that wish to sell their products in the EU.
  7. Ripple effect on global regulations: The impact of the EU MDR is not limited to the EU, as other countries are likely to adopt similar regulations in the future, leading to a global shift in medical device regulations.

Ranging from 26 May 2025 for high-risk in vitro diagnostics to 26 May 2027 for lower risk in vitro diagnostics and to 26 May 2028 for certain provisions concerning devices manufactured and used in health institutions.

Learn how we can help your medical device company navigate the new regulations and stay ahead of the competition