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In a landscape marked by escalating healthcare expenses and budgetary restrictions, mobile health (mHealth) has emerged as a game-changer. Endorsed by the World Health Organization (WHO) and national health authorities, digital therapeutics (DTx) are distinguishing themselves as a burgeoning sector within this field.
It’s important to clarify that DTx isn’t synonymous with general health and wellness apps. Unlike the latter, DTx comes with stringent regulatory requirements. These encompass clinical evidence, data protection, and a prerequisite approval from health authorities (HA) before marketing.
Notably, for DTx manufacturers targeting the European market, compliance with regulation (EU) 2017/745 (MDR) is mandatory. Let’s delve into this regulatory aspect within the EU.
DTx in Europe: The Path to CE Marking
At its core, the EU mandates that any software intended for remote patient monitoring or to aid diagnostic/therapeutic decisions is recognized as a medical device. As such, it must align with (EU) 2017/745. Beyond software validation, requisite clinical studies must also be conducted. An ISO 13485 conform quality management system is non-negotiable.
Upon receiving a favorable assessment from an EU-sanctioned Notified Body (listed on the NANDO website), the product is granted CE marking. It’s essential to understand that the timeline and costs associated are influenced by the DTx’s risk level. The MDCG risk self-assessment guidance can aid manufacturers in assessing their product’s risk.
Additionally, the EU’s robust General Data Protection Regulation (GDPR) ensures patient data privacy. Overseeing this is the independent European Data Protection Supervisor (EDPS), which guides all EU member states and institutions on data management.
DTx Risk Classification: An Overview
As described above, evaluating the risk classification of DTx is a key step towards CE marking. The most common risk classification levels for DTx are as follows:
- Class IIa: This is where most DTx software is categorized, though there are exceptions.
- Class IIb: Encompasses DTx solutions with elevated risks or potential implications.
- Class III: Limited Class III DTx products have been identified at the moment.
Cost & Time Estimates for CE Marking (Focusing on Class IIa)
- Timeline: Typically 12-18 months, but current delays exist due to a shortage of Notified Bodies.
- Cost: Varies based on internal regulatory expertise and capacity. Expected range: 60,000-100,000 EUR (includes fees for Notified Bodies solely).
The Future of DTx in Europe: What About Reimbursement?
Currently, the EU doesn’t have region-specific regulations for DTx market approval or reimbursement. However, individual countries are showing initiative. Germany stands out as the first EU nation to implement national DTx regulations and reimbursement processes.
France and Belgium are also making commendable strides in this direction. Meanwhile, the EPDS, in its Opinion Letter 29/2023, has advocated for refining EU data protection laws, with mHealth technologies anticipated to be included. The message is clear: Stay updated.
Conclusion
For those intending to market standalone software or software associated with medical devices in Europe, compliance with regulation (EU) 2017/745 is essential. Supplementary regulations at the national level also exist, focusing on DTx-specific mandates and reimbursement strategies.
The following blog posts will delve deeper into the national regulations spearheaded by trailblazers like Germany, Belgium, and France in the realm of DTx.
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