Medical technologies in the EU are subject to robust and comprehensive regulatory frameworks to ensure the highest
standards of safety, quality, and performance, thereby protecting patients and end-users. These frameworks are primarily governed by the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), which
establish stringent requirements for the development, manufacturing, and marketing of medical technologies. Compliance with these regulations is mandatory for manufacturers, who must undergo rigorous conformity assessments before placing their products on the EU market.
In addition to the sector-specific safety and performance regulations, the medical technology industry operates within a complex landscape of EU-wide horizontal legislation. This includes critical areas such as digital, environmental sustainability, and other legal requirements:
- Digital Regulations: Medical technologies are increasingly incorporating software, artificial intelligence, and data-driven solutions. As a result, EU’s digital policies, including the Artificial Intelligence Act and the European Health Data Space, aim to ensure that digital health innovations are utilised in a secure and ethical manner, fostering trust and safety in the healthcare sector.
- Environment and Sustainability: The European Green Deal and related climate and environmental legislation, such as EU Batteries, Packaging, Waste or Sustainable Products and Chemicals Regulations, impact the entire lifecycle of medical technologies.
- Other legal requirements: Depending on the products, specific additional legal requirements will need to be complied with, such as the General Data Protection Regulation (GDPR), the Product Liability Directive (PLD), and Sustainable Corporate Governance rules (e.g. CSRD, CS3D).
The medical technology sector’s ability to navigate these diverse, and sometimes conflicting, regulatory landscapes is crucial for fostering innovation while maintaining high standards of patient safety and environmental responsibility.
See resources:
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Medical Technology Regulations
Medical Technology Regulations
Learn more about the Medical Technology Regulations in the EU.
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Digital Health
Digital Health
Discover the regulations impacting digital health in the EU.
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Environmental and Social Sustainability
Environmental and Social Sustainability
Find out more about the regulations on Environmental and Social Sustainability.