The European medical technology community is calling for sweeping reforms to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), arguing that the current frameworks are creating unnecessary complexity, administrative burden, and barriers to innovation.
Following the European Commission’s public consultation in September 2025, industry groups from both sides of the Atlantic — including MedTech Europe, the European Federation of Pharmaceutical Industries and Associations (EFPIA), and AdvaMed — submitted formal recommendations urging policymakers to streamline processes, eliminate redundant requirements, and centralize oversight at the EU level.
Structural Challenges Undermining Innovation
MedTech Europe, representing more than 34,000 medical technology companies, cited “structural problems” within MDR and IVDR that have slowed product approvals and strained resources. According to the organization, the regulations have yet to achieve their intended goals of creating a predictable, transparent, and sustainable regulatory system that ensures patient safety while supporting innovation.
The group identified 83 key administrative burdens, ranging from inconsistent performance evaluations under IVDR to duplicative post-market surveillance and Unique Device Identification (UDI) reporting. More than 70% of manufacturers have reportedly had to increase staffing and compliance resources just to maintain certification.
MedTech Europe also raised concerns about fragmented governance, noting that oversight is currently distributed across multiple national authorities and notified bodies, leading to inconsistent interpretations and prolonged approval timelines. The organization proposed the creation of a single EU-level regulatory authority to coordinate and harmonize implementation.
Industry Push for Predictability and Centralized Governance
The U.S.-based AdvaMed echoed these calls, highlighting that manufacturers still face unpredictable timelines and costs for EU certification. Inconsistent interpretations of MDR and IVDR by notified bodies have led to divergent outcomes for similar products, undermining fairness and transparency.
AdvaMed endorsed MedTech Europe’s proposal for a unified governance model, stating that such a framework should prioritize patient access, strengthen accountability, and enhance Europe’s competitiveness in global medtech innovation.
Pharmaceutical Industry Warns of Ripple Effects
The EFPIA expressed concern that MDR and IVDR are having unintended consequences on medicine development and clinical trials. A 2023 EFPIA survey projected delays affecting as many as 42,000 patients over three years due to slow or inconsistent review processes.
The group emphasized that the regulations have complicated pathways for drug–device combination products and companion diagnostics, resulting in slower access to innovative therapies for patients with cancer, rare diseases, and chronic conditions. EFPIA also urged the establishment of an EU-level body to ensure harmonized application of rules, especially for products at the intersection of pharmaceuticals and medical devices.
Rethinking Recertification Requirements
Several multinational companies, including Becton Dickinson, Siemens, and Medtronic, proposed eliminating the five-year recertification cycle currently required under MDR and IVDR. They argue that the policy adds no meaningful safety benefit and consumes notified body capacity that could be better directed toward post-market surveillance and continuous oversight.
Instead, these firms recommend a surveillance-based certification model, in which ongoing audits and safety data determine continued validity — a system that would align with global quality management best practices.
Notified Bodies Seek Efficiency, Not Exemption
Notified bodies themselves are also calling for targeted reforms. TÜV SÜD defended its capacity and efficiency, stating that certification delays are more often due to incomplete or late submissions from manufacturers. Meanwhile, BSI suggested that regulators allow remote or hybrid audits for non-manufacturing sites, a move that could reclaim thousands of audit hours annually.
The EMMA International Perspective
At EMMA International, we recognize that regulatory frameworks must evolve to balance safety, efficiency, and innovation. As Europe’s medtech and pharmaceutical sectors push for modernization, the call for harmonization, transparency, and adaptive oversight has never been stronger.
Our team supports life-science organizations in navigating complex international regulations — from EU MDR and IVDR to FDA and global market requirements. Through data-driven compliance strategies and lifecycle-focused quality systems, EMMA International helps clients maintain readiness while advancing innovation that improves patient outcomes.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
Eglovitch, J. (2025, October 9). Medtech industry calls for major reforms to MDR and IVDR. Regulatory Affairs Professionals Society.
