AESGP Position on Commission Proposal for Simplification of MDR
This position paper outlines AESGP's recommendations on simplifying medical device regulations in Europe.
- Publisher
- AESGP
- Published
- Length
- 19 pages
- File
- 292 KB PDF
Download the full 19-page PDF
Free · 292 KB · Instant access after email
# Executive Summary AESGP supports the European Commission’s proposal to simplify medical device regulations while ensuring patient safety. Key recommendations include: - **Clear Product Classification**: Enhance legal certainty for medical device status. - **Proportional Scrutiny**: Maintain focus on high-risk devices to avoid unnecessary burdens. - **Digitalization**: Update regulations to support electronic instructions for lay users. - **Risk-Based Software Classification**: Ensure low-risk software can be classified appropriately without barriers. - **Stakeholder Involvement**: Include all relevant stakeholders in regulatory discussions to improve transparency.
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