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.
Develop a regulatory strategy
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.