European Medicines Agency: Medical Devices EU Regulatory Guidance
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In the European Union (EU), medical devices must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended.
Medical devices are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process.
This website outlines useful guidance on regulating medical devices in the EU.
Added on: 09 October 2024