Regulatory Enforcement Trends in 2025: Why Compliance Matters More Than Ever
- swichansky2
- Oct 17
- 5 min read
Regulatory enforcement is often the best barometer of what agencies truly care about. While guidance documents and speeches provide direction, warning letters, inspection findings, and certificate suspensions show where regulators are drawing the line. Over the last two years, both the FDA and European Notified Bodies have increased the intensity of enforcement, sending a clear message: medical device companies that do not take compliance seriously will face significant consequences.
In 2024, FDA warning letters to device manufacturers nearly doubled compared to 2023. The trend has continued through mid-2025, with particular focus on quality system breakdowns, inadequate post-market surveillance, and cybersecurity. In Europe, Notified Bodies have become more assertive, suspending certificates for companies that fail to meet MDR or IVDR requirements, especially around clinical evidence and PMS. Competent Authorities are also conducting more unannounced inspections.
This blog will explore where regulators are focusing their attention, the lessons learned from recent enforcement actions, and what executives should be doing now to protect their businesses.
FDA Enforcement Trends
Rise in Warning Letters
FDA’s Center for Devices and Radiological Health (CDRH) has clearly ramped up oversight. The spike in warning letters reflects both a return to pre-pandemic inspection levels and a more aggressive stance toward unresolved compliance issues.
Top areas cited in recent warning letters include:
CAPA Failures: Many firms have been cited for failing to perform thorough root cause analysis or to verify the effectiveness of corrective actions. In some cases, companies closed CAPAs without confirming that the problem had been resolved.
Design Control Deficiencies: FDA continues to find incomplete or missing Design History Files (DHFs). Common issues include lack of documented design inputs, inadequate verification and validation, and poor management of design changes.
Complaint Handling and MDR Reporting: FDA frequently cites companies for failing to investigate complaints adequately or to submit MDRs within the required timelines.
Production and Process Controls: Deficiencies in process validation, environmental controls, and equipment maintenance remain common findings.
Supplier Controls: Purchasing controls and contract manufacturer oversight are an increasing focus. FDA expects clear supplier qualification, audits, and monitoring.
Case Example
In early 2025, FDA issued a warning letter to a midsize device company producing home-use diagnostic kits. Investigators found the firm had received multiple complaints of false results but failed to conduct proper investigations or submit MDRs. CAPAs were opened but closed without evidence of effectiveness. The result was not only a warning letter but also delays in the company’s new product approvals.
This case highlights FDA’s growing impatience with companies that treat complaint handling and CAPA as paperwork exercises rather than tools for continuous improvement.
EU Enforcement Trends
Notified Bodies
With MDR and IVDR deadlines looming, Notified Bodies are under pressure from regulators to enforce standards strictly. NBs are issuing major nonconformities and suspending CE certificates where documentation or evidence is insufficient.
Key issues driving enforcement include:
Clinical Evidence: NBs are demanding updated, robust clinical evaluation reports for devices. Legacy data from the MDD era is often considered inadequate.
Post-Market Surveillance: PMS and PSURs are under scrutiny. Companies providing superficial or generic PMS reports are facing findings.
Technical Documentation: Poorly structured or outdated technical files continue to cause problems. NBs expect clear traceability across design, risk management, and testing.
IVDR Transition: Many IVD companies underestimated the amount of performance data required. NBs are refusing or delaying certificates until strong performance evaluation reports are in place.
Competent Authorities
National Competent Authorities are also becoming more active, particularly in conducting unannounced inspections. Several authorities have issued Article 97 notices, restricting device sales until deficiencies are corrected.
Case Example
A European implantable device manufacturer recently had its CE certificate suspended after its Notified Body concluded that the clinical evaluation did not adequately demonstrate long-term safety. The suspension forced the company to halt sales in the EU for six months, resulting in significant revenue loss.
Global Trends
Enforcement is not limited to the U.S. and EU. Authorities in China, Brazil, and India are also raising the bar. China’s NMPA has stepped up inspections of foreign manufacturers, focusing on local clinical trial requirements and UDI compliance. Brazil’s ANVISA is enforcing MDSAP requirements more strictly.
The clear message globally is that regulators are coordinating more closely and converging on high standards. Weaknesses identified in one jurisdiction can have ripple effects worldwide.
Why Enforcement is Increasing
Several factors explain why enforcement has intensified:
Post-Pandemic Backlog: Inspections slowed during the pandemic, creating pent-up demand for oversight. Regulators are now catching up.
New Regulations: MDR, IVDR, and FDA’s QMSR are raising expectations, and regulators want to ensure early compliance.
Public Safety Concerns: High-profile recalls and cybersecurity vulnerabilities have drawn media attention, prompting regulators to act.
Global Harmonization: Programs like MDSAP encourage consistent enforcement across jurisdictions.
Practical Steps to Avoid Enforcement Actions
Strengthen CAPA Systems:
Ensure every CAPA includes a thorough root cause analysis.
Verify effectiveness with data before closure.
Track CAPAs in management reviews.
Audit Design History Files:
Check for complete traceability from inputs to outputs to verification and validation.
Document design changes and rationales clearly.
Reinforce Complaint Handling:
Train staff to recognize and escalate complaints.
Trend complaint data to identify signals early.
Ensure MDRs are submitted on time.
Tighten Supplier Controls:
Qualify suppliers thoroughly.
Conduct risk-based audits.
Include clear quality agreements.
Conduct Mock Inspections:
Simulate FDA or NB inspections to uncover weaknesses.
Practice presenting records and answering investigator questions.
Strategic Implications for Executives
For CEOs, enforcement trends are a reminder that regulatory compliance is a business risk, not just a technical issue. A warning letter or certificate suspension can halt sales, damage reputation, and erode investor confidence. Executives should ensure compliance programs are well funded and that quality leaders have the authority to act.
For VPs of QA/RA, this is a time to reinforce a culture of accountability. CAPA, complaint handling, and PMS must be treated as strategic functions. Leaders should provide clear metrics to the board, such as CAPA closure times, complaint trends, and audit results.
For product and operations leaders, enforcement is a call to integrate quality into everyday work. Supplier qualification, process validation, and design documentation are not regulatory formalities; they are essential for safe, effective products and sustained market access.
Final Thoughts
Regulatory enforcement in 2025 is at its highest intensity in years. FDA, Notified Bodies, and Competent Authorities are making it clear that companies must meet elevated expectations for quality, clinical evidence, PMS, and cybersecurity.
Companies that see enforcement only as a threat will scramble to react. Companies that view it as guidance on what regulators value will proactively strengthen systems, avoid disruption, and gain competitive advantage.
How PRP Compliance Can Help: We provide mock audits, CAPA system reviews, and remediation support to help companies stay ahead of enforcement. Our experts can prepare your teams for inspections, strengthen documentation, and ensure your compliance systems meet FDA, NB, and global expectations. Contact PRP Compliance to safeguard your business from enforcement risks.