Understanding Compliance: U.S. FDA and EU MDR

Topics Covered 

1. Regulatory Overview: 

   1.1 U.S. FDA:  

   - Focuses on a tiered risk classification (Class I, II, III) with stringent controls both before and after a device hits the market to ensure its safety and effectiveness.
   - Key regulatory processes include Premarket Approval (PMA) and 510(k) pathways. 

   1.2 EU MDR: 

   - Replaces the Medical Device Directive (MDD), adding more stringent post-market surveillance and broadening the range of devices covered, including aesthetic ones.
   - Risk classifications span from Class I to Class III, with a greater focus on clinical evaluations and post-market oversight. 

2. Pre-market Requirements: 

   - FDA: Follows a structured process involving design controls (21 CFR Part 820), risk management, and clinical validation studies. 
   - EU MDR: Focuses on continuous clinical assessments, such as General Safety and Performance Requirements (GSPR), Clinical Evaluation Reports (CERs), and compliance with ISO 13485 quality systems. 

3. Software in Medical Devices: 

   - Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) have different regulatory pathways in both regions. 
   - Software risk classification differs, with both the FDA and EU MDR requiring strong cybersecurity measures, clinical validation, and post-market oversight. 
   - Compliance is aligned with standards like ISO 14971 (risk management) and IEC 62304 (software development). 

4. Post-market Surveillance: 

   - Both systems mandate continuous monitoring of devices post-market to ensure they remain safe and effective. 
   - FDA: Focuses on Medical Device Reporting (MDR) and Post-Approval Studies (PAS). 
   - EU MDR: Introduces Periodic Safety Update Reports (PSUR) and mandates manufacturers to carry out Field Safety Corrective Actions (FSCA) and Post-market Clinical Follow-up (PMCF). 

5. Risk Management and Labelling: 

   - Both the FDA and EU MDR highlight the importance of ISO 14971 for comprehensive risk management. 
   - Labelling requirements, including the Unique Device Identifier (UDI), are critical for transparency and traceability. 

6. Key Differences: 

   - FDA: A centralized system with a stronger focus on pre-market evaluations. 
   - EU MDR: A decentralized framework, relying on Notified Bodies, with more focus on post-market clinical monitoring and ongoing evidence collection. 

7. Compliance Timelines: 

   - FDA: 510(k) submissions typically take about 90 days, while PMA reviews for high-risk devices can take 180 days or more. 
   - EU MDR: Transition periods have been extended, with key deadlines now in May 2024, and further extensions granted for some devices up to 2027 and 2028.