Deadlines for the new Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) are rapidly approaching. While the final cutoff dates for MDR extend to 2026-2027 and IVDR to 2025-2027, many regulatory requirements are already in effect.

Meeting these new standards is a significant undertaking. The time to begin preparing is now, as navigating these regulations requires detailed planning and coordination.

By leveraging available tools and working closely with regulatory bodies, companies can successfully navigate the transition and avoid potential disruptions in market access. [Image courtesy of IQVIA]

Meeting the standards

Successfully navigating MDR and IVDR compliance requires a structured approach covering several key areas. From planning and training to updating technical documentation and adjusting quality management system processes and workflows, companies must take proactive steps to meet regulatory requirements and avoid disruptions.

The first step for any organization is cohesive planning, which includes a thorough evaluation of current operations. Companies must review the new regulatory requirements and understand their impact on workflows and processes. This means identifying areas where adjustments are needed, particularly regarding clinical testing and postmarket surveillance (PMS) activities.

Training teams is a critical part of the transition. Regulatory teams must be fully educated on the new requirements and updated workflows. Providing detailed overviews of the regulatory updates ensures all stakeholders can manage the transition effectively and meet the latest standards.

Organizations must also shift their regulatory workflows. This involves identifying areas needing change and implementing the necessary shifts in regulatory activities. Companies may need to realign their operations and adopt more efficient processes to comply with the updated requirements.

To support these changes, companies should explore technology and services to enhance their existing quality management systems (QMS). Automation and other innovative tools can streamline regulatory activities, ensuring compliance efforts are more efficient and effective.

While final compliance deadlines have been extended, some elements of MDR and IVDR are already in effect. Companies should focus on these immediate requirements to avoid non-compliance, particularly PMS and clinical data collection.

Under the regulations, a company must have a person responsible for regulatory compliance (PRRC) who is responsible for ensuring the compliance of released devices as well as ensuring the postmarket vigilance (PMV) and PMS requirements are enforced. This PRRC must have appropriate expertise and qualification in the field of medical devices or in-vitro diagnostics and manufacturers are required to have at least one PRRC available within their organization.

Broader regulatory considerations

Medical device companies must also account for broader regulations that could impact their products.

Regulations include the EU AI Act (especially if they are developing devices that incorporate artificial intelligence technologies) and the General Data Protection Regulation (GDPR), which has implications for handling patient data and should be integrated into compliance planning.

Environmental standards, including REACH, RoHS and WEEE, address the safe disposal and management of hazardous substances and waste, including electronic and electrical equipment.

For companies operating globally, it’s important to recognize that regulatory definitions vary between regions. For example, the EU uses the term medical device software, while the U.S. refers to software as a medical device, and the definitions differ. Companies need to account for these variations in their design and compliance strategies and recognize how this impacts their technical documentation.

Tips and tools for success

To successfully navigate MDR and IVDR compliance, companies must utilize the right tools and resources. One of the most critical strategies is working closely with regulatory bodies, especially notified bodies, to ensure that all regulatory requirements are understood and met.

• Start early: Given that notified bodies are already overwhelmed with demand, engaging with them as early as possible has been essential. Delays in reaching out could result in longer waits for certification, potentially affecting market access.
• Use AI/ML: Leveraging innovative tools such as artificial intelligence and machine learning can also streamline compliance processes. These technologies can assist with tasks like data collection, analysis and documentation, making it easier for companies to meet the stringent new regulatory requirements efficiently.
• Act quickly: Although the final deadlines for compliance have been extended, it is still critical to act quickly. While it may seem late to start, taking action now is better than waiting further, as regulatory bodies may not be available when needed. The transition process can be complex, and delaying preparations could lead to disruptions in market access. Companies should be aware that certain requirements such as PMS are already in effect and must have already been addressed.
• Review QMS: Another key aspect of preparing for MDR and IVDR compliance is reviewing the company’s QMS infrastructure. A well-established QMS is essential for meeting the new regulatory standards. Companies may need to invest in upgrades or additional resources to ensure their QMS fully supports their patient safety obligations.

By leveraging available tools and working closely with regulatory bodies, companies can successfully navigate the transition and avoid potential disruptions in market access. Early action will have ensured compliance and position companies for long-term success in the evolving medical device industry.

Read more: Understanding the changes and impact of MDR and IVDR

Mike King [Photo courtesy of IQVIA]

Mike King is senior director of product and strategy (quality, regulatory, safety and detect) for Digital Products & Solutions at IQVIA. He has close to 20 years of knowledge and experience leading localized and global teams in regulatory affairs and quality assurance and has worked within the medical and surgical, orthopedic, in vitro diagnostic, diagnostic imaging, dental and urology sectors.

Article source:Medical Design & Outsourcing