Strict rules and laws focus on securing supply and ensuring quality
Challenges: With ever-tightening legislation and regulation, medtech companies must focus on mitigating risks that could compromise product quality and security of supply. Examples of regulatory requirements include:
- European Union Medical Device Regulation (EU MDR) requires greater traceability throughout the supply chain. Compliance costs could run into the millions
- The U.S. Food and Drug Administration (FDA) requires medical device manufacturers to report disruption in the production of critical medical equipment
- A 2021 U.S. Executive Order to ensure supply chain resilience could demand greater sub-tier visibility, along with more robust sourcing and procurement strategies
- Cybersecurity requirements in medtech supply chains are tightening