MTRC Webinar: Evidence Requirements for Reimbursement and HTA of Medical Devices in Europe

Regulatory approval does not automatically provide the evidence needed to secure reimbursement, obtain a positive HTA recommendation, or support routine adoption. Across Europe, evidence expectations vary substantially by country, reimbursement pathway, care setting, technology type, comparator, unmet need, and target patient population. The same evidence package may be mandatory for a formal decision in one market, commercially decisive in another, and insufficiently aligned with local practice elsewhere. 

MTRC invites MedTech professionals to an online seminar examining the clinical and health economic evidence commonly required by European reimbursement authorities, payers, and HTA bodies. The seminar will explain how manufacturers can anticipate evidence expectations, identify gaps in their existing development programs, and align evidence generation with future market access pathways. 

During the seminar, we will discuss: 

• How evidence requirements differ across European countries and market access pathways; 
• The role of randomized trials, comparative observational studies, real-world evidence, registries, and local data; 
• Expectations concerning comparators, patient populations, subgroups, follow-up periods, and study outcomes; 
• The importance of clinical effectiveness, safety, quality of life, patient-reported outcomes, and healthcare resource use; 
• When cost-effectiveness, budget impact, cost savings, and other health economic evidence may be required; 
• Why study quality and transparent reporting can be as important as study design; 
• How previous reimbursement and HTA decisions can be used to identify evidence gaps and inform future clinical development; 
• Practical steps for integrating European market access requirements into evidence-generation plans. 

The seminar will be relevant to professionals working in Market Access, Reimbursement, HTA, HEOR, Clinical Development, Medical Affairs, Evidence Generation, Regulatory Affairs, and European launch planning. 

Speaker: Dr Oleg Borisenko, Founder and Director of MTRC 

Date and time: 17.00 CET, October 29, 2026 

Format: Online seminar. The seminar will not be recorded.  

Participation: Only representatives of the medical technology industry.  

You can register here.