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Obtaining CE certification and getting reimbursement for innovative medical devices are crucial challenges that have to be met by digital health SMEs. CE certification gets more complicated and costly due to several renewals in European standards and regulations. Tackling reimbursement challenges rather late in the life cycle of a medical device can delay launching of the product. Accordingly, reimbursement strategies and certification should be addressed together early on. The challenge for both processes is their high degree of diversity across Europe. Standards and regulations are implemented in various ways across EU Member States. Additionally, European markets are diverse, there are as many reimbursement systems for medical devices as there are countries. In order to launch a product in a new market, SMEs need to know the local policy environment, how a system is funded, how reimbursement decisions are made and how long decisions take.


- The majority of digital health SMEs need advice on certification and reimbursement strategies.

- Regulatory compliance for SMEs is crucial for investors to make decisions.

- CE certification gets more complicated and costly due to new European standards and regulations with is extremely critical for small medical software producers like app developers and start-ups.

- There is a high demand for reimbursement consultancy services - reimbursement should be addressed early on together with certification.


The challenge(s) to be compliant

Digital health SMEs and regulatory experts confirm that there are huge challenges in CE certification and reimbursement when developing and commercializing new medical devices in Europe.

The new Medical Device Regulation (MDR) will replace the current Medical Device Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD). The MDR requirements regarding the technical documentation, clinical evaluation and classification of medical devices are more detailed, complicated and stricter. In particular, rule 11 of the MDR implies that the majority of stand-alone software has to be declared as class 2a, 2b or 3 device. Only a very few exceptions might be declared as class 1 device. Consequently, in most cases producers have to involve notified bodies and establish a quality management system which has to be certified. Efforts and costs are multiplied which is extremely influential and difficult for small producers like application developers and SMEs. “Rule 11 will aggravate the development of medical software products to an extent that small manufacturers can barely overcome the regulatory hurdles”, CEO, Regulatory Consultancy for software-related medical devices.

Furthermore, the updated version of the quality management system standard,  ISO 13485:2016, leads to more complicated and time-consuming audit processes. Several notified bodies will be shut down which limits the availability of the remaining notified bodies for auditing medical device producers. This may result in a limited number of certifications for medical products in the coming years. “The ISO 13485 update is going to crush the eHealth industry”, CEO, Digital Health Start-Up.

Moreover, revision 4 of the guideline for clinical evaluation (MEDDEV 2.7/1) is only poorly taken into account respective underestimated by many medical device producers. The revised guideline includes changes in the clinical evaluation of medical products and their documentation. A number of medical devices will have to be recertified which will lead to high efforts and costs for the producers during the coming years.

There is also a high demand for reimbursement consultancy services. Not only are certification a major challenge, but reimbursement strategies also have to be considered. SMEs and their cooperation partners, even big medical companies, often do not know how to get reimbursement for new solutions. Additionally, reimbursement systems differ in each EU member state. Reimbursement strategies should be addressed early on together with certification as reimbursement is also crucial for getting market access. Hence, reimbursement consultancy will definitely be added value for European eHealth SMEs. “It would be really great and very helpful to have an expert that guides you to the best path to reimbursement in the different countries”, Co-founder and CMO, Digital Health Start-up.


What SMEs need

An online survey with 21 Digital Health SMEs revealed that most of the SMEs required advice on CE certification, in particular for the general medical device certification (71%), standards related to medical device software (57%) and quality management system (52%). Most of the SMEs (62%) need support with software related regulatory topics. Especially relevant is advice on how to determine when a software is a medical or in vitro diagnostic device (54%) and software life cycle requirements for standalone medical software (54%). Additionally, the majority of the SMEs which need advice on the decision if the software is a medical or IVD device, also need help in classifying the device (57%)

The majority of the SMEs also need support regarding reimbursement strategies, in particular for analysing pathways of reimbursement for the product in different European countries (67%). Furthermore, the development of reimbursement/health technology assessment and coordination with different stakeholders in the reimbursement process are of high relevance as well (43%).


What investors want

An online survey among 30 Digital Health investors showed that the most of the investors (80%) are faced with questions on regulatory requirements in different European countries and if there is a European directive applying to the type of solutions of the SMEs (73%). 20% of the investors seek guidance from a digital health regulatory expert to get their regulatory questions answered. The majority of the investors (63%) uses own research methods (23%) or requests help from an in-house/partner regulatory consultant (40%).

Furthermore, focus groups and events with investors, e.g. the Digital Health Venture Forum in Valencia (25 October 2016), revealed that investors always consider regulatory compliance of SMEs for their investment decisions. It is one of the first criteria they check before making that investment.


How eHealth Hub can help

The regulatory and reimbursement guidance of the Horizon 2020 funded eHealth Hub will help European eHealth SMEs to comply with regulatory requirements and to elaborate reimbursement strategies for developing and commercializing new medical devices across the European Union. Our network of European experts in medical device regulation and reimbursement will support you in obtaining market authorization and market access.

Based on their specific challenges, SMEs will be guided to appropriate regulatory and/or reimbursement nodes within the network that will deliver individual and high quality support. It is up to the SMEs to contact and negotiate the financial conditions for the advice with the regulatory service provider. If the regulatory issue relates to German regulations, eHealth Hub may be in a position to help for free, subject to capacity.


Know more about this eHealth Hub service

june, 2023

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