Delays and obstacles to obtaining marketing authorization in Europe and the US
Seance of wednesday 21 january 2026 (La prothèse trapézo-métacarpienne : de la France aux Etats Unis, un exemple emblématique de la portée internationale de l’Ecole Française)
DOI number : 10.26299/7a6f-0861/emem.2026.04.06
Abstract
Health regulations are now a major challenge for medical device manufacturers, because while they aim to ensure patient safety, they must contend with:
- A completely heterogeneous (even protectionist) regulatory framework
- Excessive financial investment
- Delays that are sometimes incompatible with competitive pressure and medical urgency.
=> This coexistence of heterogeneous regulatory systems forces companies to develop differentiated compliance strategies while maintaining overall industrial consistency.
In this environment, the new European regulation (May 2024) has had the major consequence of completely destabilizing the industry.
Product withdrawals and a brake on innovation
- High requirements and costs associated with product recertification
- Certain indications are no longer covered
This is why the FDA has become the preferred option for innovation
- A single, consistent agency
- Standardized and controlled process
- A fast-track procedure for minor development opportunities
- A competitive market with high added value
Conclusion
- The ability to reconcile regulatory compliance, technological innovation, and industrial performance is therefore key to the competitiveness and sustainability of healthcare companies, while helping to maintain the confidence of patients and public authorities.
- Nevertheless, this environment clearly aims to reduce or even destroy the industrial fabric of European, and especially French, microbusinesses and SMEs for the benefit of American multinationals.
- A completely heterogeneous (even protectionist) regulatory framework
- Excessive financial investment
- Delays that are sometimes incompatible with competitive pressure and medical urgency.
=> This coexistence of heterogeneous regulatory systems forces companies to develop differentiated compliance strategies while maintaining overall industrial consistency.
In this environment, the new European regulation (May 2024) has had the major consequence of completely destabilizing the industry.
Product withdrawals and a brake on innovation
- High requirements and costs associated with product recertification
- Certain indications are no longer covered
This is why the FDA has become the preferred option for innovation
- A single, consistent agency
- Standardized and controlled process
- A fast-track procedure for minor development opportunities
- A competitive market with high added value
Conclusion
- The ability to reconcile regulatory compliance, technological innovation, and industrial performance is therefore key to the competitiveness and sustainability of healthcare companies, while helping to maintain the confidence of patients and public authorities.
- Nevertheless, this environment clearly aims to reduce or even destroy the industrial fabric of European, and especially French, microbusinesses and SMEs for the benefit of American multinationals.