How do you interpret laws and regulations in your product development to comply with the MDR?

The European Medical Device Regulation(MDR 2017/745) represents one of the most significant regulatory overhauls in the medical device industry. For manufacturers and developers, understanding how to interpret and implement these regulations within product development processes is critical for market access and patient safety.

The MDR was designed to enhance transparency, traceability, and patient safety throughout the entire lifecycle of medical devices. Unlike its predecessor, the Medical Device Directive (MDD), the MDR introduces more stringent requirements for clinical evidence, post-market surveillance, and quality management. This expanded scope requires manufacturers to adopt a more comprehensive approach to regulatory compliance from the earliest stages of product conceptualization to market release and beyond.

Key changes introduced on MDR and the implications on your product development

The Medical Device Regulation (MDR) has significantly expanded requirements compared to the previous Medical Device Directive (MDD), particularly around:

• Clinical evidence, including clinical data on the devices themselves.
• Post-market surveillance
• Unique Device Identification (UDI)
• Economic operator responsibilities
• Increased scrutiny for high-risk devices
• The EUDAMED database requirements

The biggest challenge of these changes is gathering clinical data because many companies that relied on equivalence with another device didn't have data on their own devices. These companies need a different clinical strategy to demonstrate compliance. Gathering post-market clinical data, surveys, registries, or even new clinical investigations may be required.  Conducting a clinical trial takes time. We found ways to support manufacturers in developing a clinical strategy and supported them with surveys and PMCF reports. Our CRO is there to monitor clinical trials if needed. In addition, we have also seen significant gaps in technical documentation in many cases. It could be in shelf life testing due to changes with a device, biocompatibility, or process validation, to name a few.

Regulatory strategies are essential. The main question is: where do you want to put your product on the market? Many EU companies not only place their products on the EU market but also want to go to the US, Canada, Japan, Brazil, etc. So, it's not only the European regulations that should be considered. Other regulations in other parts of the world also determine your regulatory strategy and should be considered in the early stages of design and development. This way, you avoid having to implement design changes to meet the requirements of other regulations—a waste of money and time.

Strategic outlook

Interpreting and implementing the MDR within product development processes requires a comprehensive strategic approach that acknowledges the expanded regulatory scope and global market considerations. Manufacturers must integrate regulatory compliance into every stage of development rather than treating it as a final checkpoint. The increased requirements for clinical evidence represent perhaps the most significant challenge, demanding creative solutions that may include PMCF surveys or additional technical documentation to address historical gaps.

Successful compliance ultimately depends on developing a forward-thinking regulatory strategy that accounts not only for European requirements but also considers other major markets where the product may be distributed. By taking this global perspective and addressing regulatory demands systematically throughout the product lifecycle, manufacturers can navigate the complexities of the MDR while maintaining efficient development timelines and ensuring patient safety across all territories. This proactive approach transforms regulatory compliance from a potential obstacle into a strategic advantage in an increasingly scrutinized medical device landscape.