21 Aug 2025
Navigating the Future of Medical Device Regulations | MDR, ISO 13485 & CE Updates
Explore the future of medical device regulations with insights into MDR, ISO 13485, and CE Marking updates. Learn how manufacturers can stay compliant and competitive in a rapidly evolving industry.
1. Introduction
- Medical device regulations are evolving rapidly.
- Importance of staying updated with MDR, ISO 13485, CE Marking.
- Why manufacturers must adapt to remain competitive.
2. MDR Updates and Future Outlook
- Key changes in MDR since its introduction.
- Expected future revisions and compliance challenges.
- Practical advice for manufacturers.
3. ISO 13485 and Quality Management Systems
- Why ISO 13485 remains a cornerstone.
- Integration with MDR requirements.
- Future role in international trade.
4. CE Marking in a Changing Landscape
- CE as a market entry requirement.
- Post-Brexit and global implications.
- Trends: stricter assessments, notified bodies’ role.
5. Preparing for the Future
- Proactive regulatory strategy.
- Digital tools & compliance automation.
- Importance of training and continuous improvement.
6. Conclusion
- Medical device companies must embrace flexibility.
- Early adaptation ensures smoother market access.
- Compliance as a competitive advantage.
