Product Liability.pdf

20220712_position-paper_final.pdf
Preview of Product Liability
🔗 Source: medtecheurope.org
📊 Size: 161 KB
👤 Author: Victor Stoimenov
⬇️ Downloads: 201

Summary

The European Commission is revising the Product Liability Directive (PLD), and MedTech Europe believes it should maintain its current form, as it upholds a balance between fostering safe innovation, offering legal certainty, and allowing consumers to claim compensation for defective products. The medical technology sector is already heavily regulated by sector-specific safety legislation, such as the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices regulation (IVDR), as well as horizontal legislation like the General Data Protection Regulation (GDPR). MedTech Europe recommends guidance be developed to clarify the application of the PLD to emerging technologies, rather than revising the directive's structure and principles. Key concerns include the burden of proof, provision of information to injured persons, software as a product, and liability for AI, and MedTech Europe proposes maintaining existing principles to ensure a balanced and future-proof liability framework.

Description

The European Commission is revising the Product Liability Directive (PLD), and MedTech Europe believes it should maintain its current form, as it upholds a...

Technical Information

  • File Format: PDF
  • File Size: 161 KB
  • Pages: 8
  • Language: EN
  • Author: Victor Stoimenov
  • Total Downloads: 201
  • Last Updated: 1 day ago

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