Healthtech companies venturing into the European market encounter a familiar set of challenges when it comes to product launch. These challenges often manifest as the need for adaptations to fulfill regulatory requirements, funding constraints, and the complexities of reimbursement schemes, among others. Luxinnovation’s new webinar initiative for healthtech companies is tailor-made to address these pain points and offers step-by-step guidance, ensuring a successful product launch into the European market.
Companies that understand the different rules that apply to their innovations can enter the market faster.
European funding for healthtech companies
The webinars are scheduled to hold on a monthly or bi-monthly basis, with each episode discussing distinct aspects that simplify the journey for healthtech companies. The first webinar in July, explored available EU funding opportunities in the health domain. It also highlighted the various ways that Luxinnovation supports companies to access these opportunities, and special consideration was given to areas where SMEs are active.
“Healthtech companies can take advantage of funding opportunities under Horizon Europe. These are, however, competitive calls with specified requirements. Calls under the health cluster have fixed topics, whereas other instruments are more open. Consortia must include organisations from at least three different member states or associated countries to Horizon Europe, although the average size today is around 12 to 15 consortium members,” explains Francesca Borrelli, Senior Advisor, European R&D and Innovation Support.
We aim to provide enterprises with an insider’s perspective, allowing them to better understand the often-complex requirements.
The first webinar helped companies clarify these basics, and also explored other programmes, such as the Innovative Health Initiative, an EU public-private partnership funding health research and innovation, and the EU4Health programme with a €5.3 billion budget for the 2021-2027 period.
CE marking in 10 steps and market launch support
The next three webinars will be held on 26 September, 26 October and 5 December 2023. These will cover in same order: the ten essential steps to achieve CE marking from the perspective of designated EU MDR notified body SGS, the clinical research services of the Translational Medicine Operations Hub of the Luxembourg Institute of Health, and the testing and support services of the Eurofins Group, headquartered in Luxembourg.
EU MDR notified bodies are entities appointed by member states to assess medical devices and technical documentation to ensure compliance with the associated EU law before a product is placed on the market.
“Companies that understand the different rules that apply to their innovations can enter the market faster. The upcoming webinar with Vasily Kalakutskiy, Medical Product Certification expert at SGS, will delve into the specific legal prerequisites at European level. By covering a wide range of topics together with the responsible agencies, we aim to provide enterprises with an insider’s perspective, allowing them to better understand the often-complex requirements,” elaborates Anne Meunier, Senior Advisor HealthTech at Luxinnovation.
“Thanks to our close contact and discussions with companies, we’ve been able to identify several areas of interest and specific subjects that will be explored during this webinar series,” Mrs Meunier continues, “it has also been organised in a way that ensures a logical and coherent progression in the discussions.”
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