Impact of MDR Software Regulations on Medical Device Innovation

MDR software regulations under the EU’s Medical Device Regulation (EU 2017/745) are creating heavy operational and financial pressures, according to a survey of 35 SaMD manufacturers listed in the EUDAMED database. Financial burdens hit 88.6 % of respondents at significant or severe levels, while delays and stricter clinical-evidence requirements each scored a median impact of 4. These constraints have already led 23.1 % of firms planning launches to cancel new products, 34.8 % of multi-product companies to drop existing ones, and 17.1 % to exit the EU market.

Cost and Evidence Pressures Mount

Increased costs emerged as the leading obstacle, affecting both SMEs and large enterprises with no respondents reporting negligible effects. Additional time demands and clinical-evidence mandates each affected more than 60 % of firms at significant or severe levels. Up-classification from Class I to Class II or higher hit 48.4 % of companies that previously operated under the Medical Device Directive, amplifying burdens across cost, timeline, and evidence domains. Limited Notified Body capacity affected 69 % of firms requiring certification, while gaps in regulatory guidance were cited by 54.3 %.

Survey Design and Lasting Regulatory Friction

An online survey of 691 SaMD manufacturers in the EUDAMED database produced 35 responses (5.35 % rate) in April–May 2025. Questions were drawn from eight theoretically identified hindering domains, including complex requirements, clinical-trial mandates, expense increases, classification ambiguities, Notified Body scarcity, knowledge deficits, guidance shortfalls, and software-update constraints. The instrument used 5-point Likert scales, multi-answer items, and binary questions; data were analysed with medians, percentages, and non-parametric tests in SPSS.

Market Retreat and Policy Remedies

MDR software regulations are also driving geographic relocation and reduced product availability, trends that disproportionately affect the 90 % of medtech firms that are SMEs. Only 22.9 % of respondents viewed CE marking as worthwhile for direct-to-consumer models, compared with 60–68.6 % for sales to professionals, institutions, or insurers. Proposed supports—certification assistance (valued by 63 %) and reimbursement schemes (prioritised by SMEs)—point to practical steps that could preserve both oversight and continued innovation.