With the EU Medical Device Regulation (MDR) now fully in effect as of 2024, replacing the long-standing Medical Device Directive (MDD), medical device companies worldwide are facing a new regulatory reality. For small and medium-sized enterprises (SMEs), MDR represents more than a compliance challenge—it’s a strategic crossroads that may determine whether they remain in the European market or exit entirely.
According to the European Commission, by the end of 2023, over 30% of MDD-certified products had yet to complete their MDR transition. The delay rate among SMEs was especially high—reaching 45%—as limited internal resources, increasing regulatory costs, and prolonged review timelines combined to push many companies toward difficult decisions. Some SMEs have already begun withdrawing low-margin product lines, redirecting focus to higher-value items that justify the cost of certification. MDR, in effect, is reshaping not just compliance but the competitive landscape of the industry.
Three Core Challenges SMEs Are Facing
For SMEs, the pressure is being felt on multiple fronts. The following are the most critical pain points:
1. Rising Compliance Costs
MDR places significantly higher demands on clinical evidence, risk management documentation, and post-market surveillance. Preparing MDR technical documentation now requires 30% to 50% more consulting and documentation resources compared to MDD. Combined with longer Notified Body review timelines, this creates a substantial increase in overall compliance costs.
2. Talent and Knowledge Gaps
Many SMEs lack in-house regulatory affairs expertise. Without a deep understanding of MDR structures—such as conformity assessment routes, EUDAMED registration, and UDI systems—companies often face delays due to repeated documentation revisions and ineffective communication with Notified Bodies.
3. Market Sustainability Risk
Failing to complete MDR certification within the regulatory deadline means losing access to the EU market. For SMEs relying heavily on European sales or distributors, this can create existential threats to business continuity and brand credibility.
Strategic Paths to Break Through
Despite these challenges, SMEs still have viable strategies to navigate the MDR transition and position themselves for long-term competitiveness:
1. Prioritize High-Value Products and Phase the Transition
Not every product needs to be transitioned simultaneously. A risk- and value-based prioritization can help. Companies should first invest in transitioning their most profitable, strategically important, or technologically differentiated products, while deferring or retiring lower-margin items.
2. Build a Strong Regulatory Support Network
Working with experienced EU-based consultants, distributors, or regulatory specialists can significantly reduce knowledge gaps and documentation errors. Some regional distributors now offer technical file pre-reviews or even facilitate Notified Body interactions—shortening timelines and improving outcomes.
3. Integrate MDR into a Global Regulatory Strategy
Instead of treating MDR as an isolated requirement, consider aligning it with broader market entry plans. Documentation and testing for MDR can often be leveraged for FDA 510(k), PMDA, or TGA submissions with minor adjustments, maximizing resource efficiency and regulatory flexibility.
Long-Term: A Challenge—and an Opportunity to Elevate
While MDR undoubtedly places new burdens on SMEs, it also sets a higher bar for trust, quality, and competitiveness in the global market. The companies that invest in regulatory systems, prioritize strategically, and embrace long-term planning will emerge stronger and more resilient.
MDR is not just a hurdle—it’s an invitation to level up. And for SMEs ready to adapt, it may well be a gateway to a more sustainable, innovation-driven future in global healthcare markets.
