Adapting to Global Regulatory Changes in Orthopaedic Device Manufacturing

Introduction:

As regulations become more stringent, MedTech manufacturers must adapt to ensure compliance while continuing to innovate. Most orthopaedic devices fall under regulations driven by an increasing demand for safer, more effective medical device testing. Regulatory professionals in the orthopaedic market must stay abreast of these changes to ensure compliance and maintain market competitiveness. This blog explores key considerations for adapting to European Union’s Medical Device Regulation (EU MDR) regulatory changes.

1. Increased Demand for Clinical Testing

Clinical testing is a cornerstone of the regulatory process for high risk (class III) orthopaedic devices. The MDR has introduced more stringent requirements, demanding robust clinical data to demonstrate the safety and efficacy of these devices.

Key Considerations:

• Regulatory Requirements: The EU MDR requires comprehensive clinical evaluations, including clinical investigations for higher-risk devices. Manufacturers must provide substantial clinical evidence to support the safety and performance of such orthopaedic devices.
• Clinical Trials: The MDR places a strong emphasis on well-designed clinical trials, particularly randomized controlled trials (RCTs), as they provide high-quality evidence.
• Ethical Considerations: Ethical compliance in clinical testing is paramount under the MDR. Transparency in reporting trial results is also crucial, as is adherence to ethical standards in the design and conduct of clinical investigations.

2. Emphasis on Dependable Clinical Evidence – Role of real world evidence (PMCF Surveys)

Notified Bodies (NB) demand comprehensive data to assess the long-term safety and performance of orthopaedic products. Post-Market Clinical Follow-up (PMCF) surveys play a crucial role in generating EU-MDR compliant robust data, especially for medical devices with limited clinical data.

Key Points:

• Real-World Evidence: The level of data quality generated by PMCF surveys, as per MDCG 2020-6, can be on par with or exceed other methods, providing reliable evidence for regulatory submissions. While clinical investigations can take over a year to set up, PMCF surveys can generate high-quality data within a shorter timeframe, making them an attractive option for legacy devices with limited clinical data. In orthopedics, where device performance can vary significantly across different patient demographics and activity levels, PMCF surveys can provide a more comprehensive understanding of device performance in the real world.
• Data Quality: High-quality clinical data, obtained from well-designed studies, is essential. This includes accurate reporting of adverse events, device performance, and patient outcomes. In orthopaedics, this data might include metrics such as implant longevity, rates of revision surgery, and patient-reported outcomes on pain and mobility. PMCF surveys can help collect this data from various patient populations (e.g., pediatric, geriatric) and ensure continuous data collection at multiple intervals, such as 3- and 6-months follow-up.

3. Compliance with International Standards

The globalization of the medical device market necessitates adherence to international compliance standards. Manufacturers must navigate various regulatory frameworks to market their products globally.

Key Points:

• ISO Standards: The International Organization for Standardization (ISO) provides numerous standards relevant to orthopaedic devices, such as ISO 13485 for quality management systems and ISO 14971 for risk management, chemical characterization of materials used in medical devices. It is part of the ISO 10993 series, which is focused on the biological evaluation of medical devices. Compliance with GDPR and HIPAA standards for data security is also essential, ensuring patient data is protected through encryption, pseudonymization, or anonymization, and clear privacy policies.
• Harmonization Efforts: Initiatives like the International Medical Device Regulators Forum (IMDRF) aim to harmonize regulatory requirements across different countries, simplifying the compliance process. Adhering to these harmonized standards can streamline international market entry.

4. Enhanced Post-Market Surveillance

Post-market surveillance (PMS) is critical for monitoring the safety and effectiveness of orthopaedic devices after they reach the market. Regulatory agencies require continuous monitoring to identify and mitigate potential risks.

Key Points:

• Data Collection: Effective PMS relies on systematic data collection from various sources, including healthcare providers, patients, and device registries. PMCF surveys are an efficient method for gathering this data. They can focus on collecting data from diverse patient populations (e.g., pediatric, geriatric) and at multiple intervals. PMCF surveys can cover all indications and claims, clinical endpoints (primary and secondary), and adverse event and usability data.
• Cost and Efficiency: Clinical investigations can be resource-intensive and costly, whereas PMCF surveys are generally less expensive and quicker to implement, with a setup time of about 3 months and ongoing data collection. This proves to be an effective strategy for class II and legacy devices.

5. Focus on Post-Operative Safety Data

Ensuring the safety of orthopaedic devices during the post-operative stage is crucial. Regulators require detailed safety data to assess long-term outcomes and potential complications.

Key Points:

• Follow-Up Studies: Post-operative follow-up studies are essential to gather long-term safety and efficacy data. These studies should monitor patients for potential complications such as infection, device failure, and adverse reactions.
• Patient Monitoring: Continuous monitoring of patients who have received orthopaedic products such as implants can provide valuable safety data. This can be achieved through regular medical check-ups, imaging studies, and patient-reported outcomes.

Conclusion

Adapting to global regulatory changes in orthopaedic device manufacturing requires a multifaceted approach. While this may result in fewer new products entering the market and a slower rate of new orthopaedic device introductions compared to regions with less stringent regulations, it ultimately prioritizes patient safety. However, manufacturers have noted that this could lead to increased prices for new products due to the higher costs associated with compliance. By choosing clinical surveys for legacy and low risk devices, manufacturers can ensure safety and efficacy of their products while maintaining market competitiveness.