Support for eHealth SMEs concerning CE certification and reimbursement strategies

Our network will help you to comply with regulatory requirements for CE certification and quality management as well as the question how your digital health solution can be reimbursed in countries of the European Union. Our experts can help you to answer questions such as: Is my digital health solution a medical device? Which classification does my medical device fall into? Which steps do I have to go to get the CE marking? How can my ehealth solution be paid for by Public Health Authorities? If you need our support contact us and register here: https://ehealth-hub.typeform.com/to/bRax5a

To obtain CE certification and to get 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 new medical device related EU 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. 

Ehealth SMEs are faced with the new Medical Device Regulation and various updated standards such as  ISO 13485:2016. 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 and European regulations, how a system is funded, how reimbursement decisions are made and how long decisions take.

How can eHealth Hub help you?

The regulatory and reimbursement guidance of the 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 your specific challenges, you will be guided to appropriate regulatory and/or reimbursement experts within the network that will deliver individual and high quality support. It is up to you to contact and negotiate the financial conditions with the regulatory service provider.

References

Launched in October 2016, eHealth Hub is an EU-funded initiative that is cross-border and exclusively focused on the digital health vertical. Our mission is to provide long-term support to the ecosystem stakeholders and address key challenges facing European SMEs in this space: fine-tuning a business model, securing investments, engaging the demand-side and accelerating commercialization, getting legal and regulatory guidance to develop solutions in compliance with a multi-layer complex framework.

Partners of the initiative include: TICBIOMED, Spain, EDITO, France, Queen Mary University of London, United Kingdom, University of Amsterdam, the Netherlands, META Group, Italy, inno TSD, France, Steinbeis-Europa-Zentrum, Germany, APRE, Italy and engage AG, Germany.

For more information, please visit www.ehealth-hub.eu

Documents for download

• Regulatory_Guidance_ST.pdf

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Comments

• Alfred Manziala Saturday, 20 January 2018 - 18:28 UTC

  I did find this article very interesting.
  What happen with regulation in area of healthy food which is growing now in EU. The difficulty still similar or more waste again. This is a huge barrier which needs to remove to avoid drop down of innovation in the area of health. The complexity of legal system in EU has history to back up Sciences and Innovation contrary to US Health Authority.