MDR Burden Weighs on Digital Health Manufacturers

Digital health manufacturers developing software-type products face growing pressure under the European Medical Device Regulation. Costs, longer timelines, clinical evidence requirements and Notified Body access remain key concerns, while some companies have cancelled launches, reduced portfolios or reconsidered market participation. A recent analysis published in npj Digital Medicine examined these effects through an online survey of manufacturers identified through EUDAMED. Most respondents were small and medium-sized enterprises. Certification also appears to hold less value when products target individual consumers rather than healthcare professionals, institutions, governments or insurers.

Costs and Evidence Shape Business Strain
Additional costs stand out as the clearest source of pressure. Nearly nine in ten respondents indicated that the financial burden had a significant or severe effect on their operations. The impact was not limited to smaller companies, as larger organisations also reported serious cost-related pressure. This suggests that the regulation creates a broad financial challenge across company sizes, rather than a difficulty confined to early-stage or resource-limited businesses.

Longer timelines and stronger clinical evidence requirements also weigh heavily on manufacturers. Many companies indicated that bringing a product to market now takes more time, while demonstrating clinical value requires more work and resources. These requirements can be especially demanding for software developers whose products may need frequent updates and whose development cycles differ from those of traditional medical devices.

Regulatory knowledge and guidance remain uneven. Some companies considered their own knowledge of requirements sufficient, while a similar share did not. Guidance appeared to be a larger concern, with more than half of respondents indicating that they lacked enough regulatory clarity. Experience under the previous Medical Devices Directive did not remove these difficulties. Notified Body availability also remains a major constraint for companies that require external assessment, adding another point of delay and uncertainty in the pathway to market.

Market Choices Reflect Regulatory Pressure
The responses indicate that regulatory pressure affects product strategy as well as compliance work. Several companies had cancelled a planned launch because of the Medical Device Regulation, while others had discontinued at least one existing product. Some respondents were exiting the EU market for at least one product while continuing to sell elsewhere, and a notable minority were considering shutting down operations because of the regulatory burden.

These decisions matter because they relate directly to the availability of digital medical devices. When companies cancel launches or reduce portfolios, fewer products remain available to buyers. When products are withdrawn from one region but remain available elsewhere, regulatory pressure becomes a factor in market access. The responses do not show that every company follows this path, but they do demonstrate that these consequences are already present among surveyed manufacturers.

Product classification adds another layer of difficulty for companies that previously operated under the Medical Devices Directive. Almost half of the respondents with experience under the earlier framework had to move products from Class I to at least Class II. This shift brings stricter requirements and requires Notified Body involvement. Companies facing upclassification described substantial effects on costs, time and clinical evidence work. However, those pressures were not limited to companies whose products changed class. Added expense, delay and evidence requirements affected manufacturers more broadly, including those without upclassification.

Buyer Type Shapes Certification Value
CE certification appears to hold stronger business value when the buyer is part of the healthcare system. Manufacturers were more likely to see certification as worthwhile when buyers were medical professionals, institutional purchasers, government bodies or insurers. By contrast, certification was seen as less worthwhile when the end buyer was an individual consumer. Only a minority agreed that certification was valuable in that consumer-facing setting, while a much larger share disagreed.

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This distinction points to an important commercial tension in digital health. Certification may be more recognised or demanded in professional and institutional settings, where buyers are more likely to consider regulatory status when making decisions. Individual consumers appear less likely to create the same incentive for certification. For companies developing lower-risk tools, the business case for pursuing certification can therefore look weaker when products are aimed directly at consumers.

Manufacturers also identified the types of support that would be most useful. Help with certification was the most frequently selected option, followed closely by government reimbursement schemes. External funding for certification and clinical trials also attracted support from around half of respondents. The preference for certification assistance suggests that manufacturers need more than financial help alone. Practical guidance, clearer classification and support with clinical evaluation also emerged as relevant needs, particularly for companies navigating complex software-related requirements.

The survey results present a difficult operating environment for digital health manufacturers under the Medical Device Regulation. Costs, longer development timelines, clinical evidence expectations, guidance gaps and Notified Body access all contribute to the burden. The effects extend beyond compliance work into launch decisions, product portfolios and market participation. Certification remains more attractive when buyers are healthcare professionals, institutions, governments or insurers than when products target individual consumers. Support priorities centre on certification help, reimbursement options and funding for certification and clinical trials.

Source: npj Digital Medicine

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