European Commission Launches the Digital Fitness Check: Implications for Medical Device Manufacturers
The European Commission has published a Call for Evidence for its upcoming Digital Fitness Check, an initiative aimed at evaluating how the EU’s digital rulebook affects competitiveness, innovation and administrative burden. This review forms part of the broader EU simplification agenda outlined in A Simpler and Faster Europe and reflects the political guidance of the 2024–2029 Commission.
The Digital Fitness Check will examine how digital legislation—including data regulations, cybersecurity rules, online services frameworks and sector-specific laws—interact with each other. This cumulative assessment aims to identify overlaps, contradictory requirements, excessive reporting burdens and opportunities for streamlining.
Impact on Medical Device Manufacturers
Although the initiative is broad and cross-sectoral, it has significant implications for medical device and IVD manufacturers, who are increasingly impacted by digital, cybersecurity and data-related obligations across EU legislation.
1. Overlap between digital and sector-specific rules
Medical device manufacturers already operate under stringent frameworks such as EU MDR/IVDR, AI Act, GDPR, Cyber Resilience Act and sectoral cybersecurity schemes. The Fitness Check aims to map these interactions, which may lead to future proposals reducing duplications and clarifying definitions.
2. Potential reduction of administrative burden
The Commission highlights the disproportionate impact digital rules have on SMEs and small mid-caps—categories in which many MedTech manufacturers fall. This review may result in simplified reporting obligations, streamlined documentation requirements, and more consistent terminology across legislation.
3. Improved coherence and predictability
Manufacturers often face conflicting expectations between digital regulations and device-specific regulatory frameworks. The Fitness Check will look at definitions, scopes and governance mechanisms, potentially paving the way for greater clarity on concepts such as "data access", “cybersecurity measures”, “AI system obligations” and “risk management”.
4. Future-proofing innovation
The initiative explicitly seeks to ensure that rules remain innovation-friendly, avoiding barriers that may slow down development of digital health solutions, software as a medical device (SaMD) or connected devices.
5. Importance of stakeholder participation
The Commission is actively collecting input from companies through consultations running from 19 November 2025 to 11 March 2026. Manufacturers are encouraged to contribute, especially those working with digital technologies, AI components, connectivity and data-driven products.
As digital obligations increasingly overlap with medical device regulation, the Digital Fitness Check may shape the future regulatory landscape for MedTech manufacturers across Europe. Smart MDR will continue to monitor developments closely and inform stakeholders of upcoming changes.
The full Call for Evidence document is available for download below.
