Compliance is a top priority in eHealth. European manufacturers of digital health technologies must comply with all laws and regulations applicable to their operations and business activities. In addition to the local laws, many European Union rules apply directly. Laws and regulations can however often be difficult to understand for entrepreneurs, which makes outsourcing one of the best options. But, where do you go to? 

Find out how we can help with the newly released eHealth HUB Smart Guide “Guidelines to Frequent Legal and Regulatory Challenges of European eHealth SMEs”. It is now available for free download.  

At eHealth HUB, over the last 24 months, we have organized many workshops around Europe and offered guidance to nearly hundred SMEs. We have learned a lot from the questions SMEs raised.
The two main challenges to digital health SMEs were the new General Data Protection Regulation (GDPR) which came into force 25 May 2018 and the new Medical Device Regulation (MDR, 2017/745/EU) which came into force one year earlier on 25 May 2017. Additionally, Intellectual Property Rights (IPR) and further Medical Device related topics are challenges to SMEs. The main pitfall is their practical implementation.  

At eHealth HUB, we have summarized the most interesting case studies on legal and regulatory topics for European eHealth SMEs, to give an insight into the questions SMEs have and how these can be solved.  

This eHealth HUB Smart Guide, titled “Guidelines to Frequent Legal and Regulatory Challenges of European eHealth SMEs” introduces five cases on legal topics: three cases on GDPR and two cases on Intellectual Property Rights. Furthermore, it highlights four important topics along the road to a CE-marked medical device.  

Are you also struggling with any of these topics, the Guidelines to Frequent Legal and Regulatory Challenges of European eHealth SMEs” are now for free download.

april, 2019

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