Module 17 2024

03/12/2024

Recent Updates to Environmental Legislation (2024)

 1. EU Battery Regulation (2023/1658): Stricter recycling, durability, and carbon footprint rules.  2. EU Ecodesign for Sustainable Products Regulation: Expanding eco-design rules, including medical devices.  3. Updated SVHC List under REACH (2024): New substances impacting manufacturers.  4. EU RoHS Directive Amendments (2021/1978): Adjusted exemptions for lead-based components.  5. Proposed US Federal Legislation on E-Waste (2024): Aligns with WEEE requirements.  6. Sustainability Reporting Directives (CSRD, 2023): Mandatory environmental reporting for large companies.

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How does all of this impact Regulatory?

Let's recap your role and responsibilities How can this be accomplished?

The regulatory considerations are significant*

Impacts existing products as well as pipeline products

Points to consider

Global considerations

How do you manage the dynamics internally?

Cost increases Loss of preferred provider?

External suppliers and vendors? Issues?

Documentation Timing Effort

Regulatory approvals and market authorisations

Reporting requirements

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