Event Recap: HFE Regulatory Session: Clinical Evaluation Under MDR & FDA

On June 19, Health Founders Estonia organized the first MDR and FDA regulatory deep dive event in Estonia. The event was organized to help SMEs manufacturing medical devices and ecosystem stakeholders involved in the clinical evaluation processes to ensure products meet regulatory requirements and can be placed on the EU and US markets.

 

Joining us as speakers were:

  • Matthew DiFranco. A leader in healthcare innovation with over 15 years of international experience in AI-driven medical imaging, digital pathology, and medical device development. 
  • ​Urmeli Katus. An epidemiologist with expertise in studies that utilize real-world evidence and primary data collection. Her work also includes the critical appraisal of scientific literature and evidence synthesis. ​She currently serves as a Senior Methodologist and Head of the Center for Evidence-Based Practice at the University of Tartu.
  • ​Jevgenija Tamm and Piret Põiklik from the Estonian State Agency of Medicines.

 

Matthew led a workshop on Clinical Evaluation under MDR/IVDR (and some comparisons with FDA). The main takeaways from his workshop were:

  • Get informed about the requirements and importance of Clinical Evaluation.
  • Engage qualified experts who have been through the process.
  • Integrate your regulatory strategy with your overall business strategy.
  • Engage your target users early and often to ensure you are not only safe and effective but marketable and scalable.

Six startups also had the opportunity to schedule one-on-one individual office hours with Matthew to discuss their companies’ regulatory strategies.

 

Urmeli provided an overview of the various ethics committees that oversee biomedical and human research in Estonia. The main takeaways from her presentation were:

  • Think through what you are doing – ensure that your study is methodologically sound. If necessary, consider involving a scientific partner.
  • Use the guidance materials on the committee’s homepage; you do not need to reinvent the wheel! Before submission, check that all of your documents (e.g., instruments, scales, and consent forms) are final.
  • If well prepared, the process of gaining ethical approval is straightforward.

 

Jevgenija and Piret provided an overview of the most essential points to consider when planning a clinical investigation of medical devices or a performance study of in vitro diagnostic medical devices. The main takeaways from their presentation were:

  • If you have questions or need clarification, please contact the Estonian State Agency of Medicines for assistance before submitting any applications or notifications. Do not hesitate to use guidance materials: most questions have already been asked and addressed by others.
  • Consider the type of clinical investigation or performance study that will be conducted before filling out any forms to save time and reduce stress.
  • Be prepared for the processes to be time-consuming.

 

Please find all the materials shared at the event here.

 

The HFE program is funded by the EU through Enterprise Estonia, in collaboration with Startup Estonia, to build a strong, globally competitive health tech ecosystem in Estonia.