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
Quick answer
AESGP Position on Commission Proposal for Simplification of MDR is a 19-page whitepaper from AESGP covering EU pharma intelligence. This position paper outlines AESGP's recommendations on simplifying medical device regulations in Europe.
Why this matters
This position paper outlines AESGP's recommendations on simplifying medical device regulations in Europe.
Executive summary
- This position paper outlines AESGP's recommendations on simplifying medical device regulations in Europe.
Market Impact
| Regulatory | high |
|---|---|
| Commercial | high |
| Competitive | medium |
| Investment | high |
Who should read this
- EU market access specialists
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# 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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