Navigating the Top 6 Medical Device Compliance Issues in the Next 12 Months

As the medical device industry continues to evolve, manufacturers face an increasingly complex regulatory landscape. Staying compliant is not just about meeting legal requirements; it’s about ensuring patient safety and maintaining market access. Here are the top six compliance issues that will demand more of a medical device manufacturer’s time in the next 12 months.

FDA Rule on Lab Developed Tests (LDTs)
By May 6, 2025, laboratories must implement processes for complaint handling, submitting medical device reports (MDRs), and conducting recalls for lab developed tests (LDTs). This includes ensuring compliance with FDA’s in vitro diagnostic (IVD) labeling requirements. The new rule aims to enhance the safety and reliability of LDTs, which are critical for diagnosing various conditions.

Adoption of ISO 13485 by FDA 
FDA has amended its quality system (QS) regulation to harmonize with ISO 13485, an international standard for medical device quality management systems. US-focused companies must align their quality management systems (QMS) with ISO 13485 by February 2, 2026. This alignment will streamline regulatory processes and ensure global consistency in quality standards.

EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) 
The European Union has extended transition timelines for certain medical devices and in vitro diagnostics. Manufacturers need to ensure compliance with these updated regulations, which emphasize the importance of clinical evidence, post-market surveillance, and traceability. The MDR and IVDR aim to improve patient safety and device performance across the EU market.

Cybersecurity 
With the increasing threat of data breaches, manufacturers must enhance their cybersecurity measures to protect sensitive patient data. Compliance with regulations like the Health Insurance Portability and Accountability Act (HIPAA) is crucial. Robust cybersecurity protocols not only safeguard patient information but also ensure the integrity and functionality of medical devices.

Artificial Intelligence (AI) Act in the EU 
Medical devices incorporating artificial intelligence will fall under the high-risk category and require oversight by an AI-designated Notified Body. This regulation, which will apply starting August 2, 2026, aims to ensure the safety and efficacy of AI-driven medical devices. Manufacturers must prepare for rigorous assessments and continuous monitoring of their AI technologies.

Data Integrity 
Regulatory agencies are increasingly finding inaccuracies and inconsistencies in data generated during the medical device product development life cycle, especially with recent regulatory changes and the post-pandemic work environment. These data integrity issues can hinder or halt market access. To prevent compliance gaps, it’s crucial to have robust systems in place and thoroughly review and vet data from internal and external sources, including clinical, laboratory, engineering, and third-party solutions.

Conclusion
The next 12 months will be pivotal for medical device manufacturers as they navigate these compliance challenges. Staying ahead of regulatory changes and implementing robust compliance strategies will be crucial for maintaining market access and ensuring patient safety. By addressing these top six issues, manufacturers can better prepare for the future and continue to innovate in the medical device industry.