Health Holland Masterclass | Regulatory Approval (MDR / FDA)

Join the Health Holland Masterclass on Regulatory Approval

Are you a Dutch Life Sciences & Health (LSH) company looking to bring your medical technology to international markets?

Regulatory approval is a critical step in international growth, but navigating an increasingly complex regulatory landscape can be challenging. From evolving European requirements under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to FDA requirements in the United States and additional country-specific regulations, regulatory pathways can have a significant impact on international market access.

During this Health Holland Masterclass, Task Force Health Care and MedEnvoy Global will bring together regulatory expertise and practical experiences to explore the latest developments, challenges and considerations for Dutch LSH companies navigating international regulatory approval.

Join us to strengthen your regulatory knowledge and prepare your organisation for international growth.

Event Details

For: Dutch Life Sciences & Health organisations active in MedTech and medical

5 November 2026

15:30

17:00

Netherlands, Europe

Social Impact Factory, Vredenburg 40, 3511 BD Utrecht

Free of Charge

How This Event Supports Your Growth

For Dutch MedTech companies with international ambitions, regulatory approval is an essential part of bringing innovative healthcare solutions to new markets. However, different regulatory frameworks, changing requirements and increasing costs can significantly influence internationalisation strategies.

In Europe, companies continue to navigate the MDR and IVDR while regulatory reforms are developing. Beyond Europe, FDA requirements in the United States and additional national requirements in markets such as Switzerland, Saudi Arabia and India can add further complexity.

Understanding these regulatory pathways can help companies make informed decisions about market prioritisation, product registration, and international expansion.

What to Expect?

During this interactive masterclass, participants can expect:

An update on current developments around the MDR and IVDR
Insights into recent developments related to FDA approval
Practical perspectives on navigating regulatory approval processes
Discussion of the costs and complexity associated with regulatory compliance
Examples of how additional national requirements can influence international market-entry decisions
Experiences and lessons learned from entrepreneurs navigating regulatory pathways
Opportunities to exchange questions and experiences with regulatory experts and fellow LSH companies

Preliminary Progamme

15:15 – 15:30	Walk-in
15:30 – 15:40	Welcome & Introduction Andrea O’Brien, Task Force Health Care
15:40 – 16:15	Navigating Regulatory Approval: MDR, IVDR & FDA An update on current regulatory developments and key considerations for Dutch MedTech companies navigating European and US approval pathways. Dusica Milenkovic, MedEnvoy Global
16:15 – 16:35	From Approval to International Market Access How additional national requirements, local obligations and regulatory costs can influence market-entry decisions beyond MDR and FDA approval. Dusica Milenkovic, MedEnvoy Global
16:35 – 16:50	Entrepreneur Perspective: Regulatory Approval in Practice Practical experiences, challenges and lessons learned from navigating regulatory pathways as part of international growth. Jessica Adams, Presurgeo
16:50 – 17:00	Q&A & Closing
17:00 onwards	Networking Drinks

Speakers

Dusica Milenkovic

Senior Consultant, Regulatory Affairs, MedEnvoy Global

Supporting medical technology companies in navigating international regulatory requirements, including MDR, IVDR and FDA approval, to facilitate global market access.

Jessica Adams

CEO, Presurgeo

Developing AI-powered solutions for orthopaedic care, including automated 3D bone analysis and surgical planning, to support more precise and standardised treatment.

Who should participate?

Regulatory requirements do not stop at obtaining MDR or FDA approval. Companies expanding internationally may encounter additional registration requirements, local obligations and significant differences in regulatory costs between markets.

This masterclass will help participants better understand how these considerations can influence international strategy and provide practical insights for navigating regulatory pathways more effectively.

By bringing together regulatory expertise from MedEnvoy Global and experiences from Dutch LSH entrepreneurs, the session provides an opportunity to learn from practice, discuss current challenges and connect with peers facing similar regulatory questions.

Participation costs

Attending this Health Holland Masterclass is free of charge.

Please note: if you are unable to attend, please deregister at least one day before the event. A fee of €75 will be charged in the case of a no-show to cover venue and catering costs.

Register Now

Registration is now closed.

Thank you for your interest in the Health Holland Masterclass on Regulatory Approval! Due to the high number of registrations, we have reached capacity for this session.

Would you still like to attend? Please contact Andrea O’Brien at andrea.obrien@tfhc.nl to be added to the waiting list. We will get in touch if a place becomes available

We look forward to welcoming you in Utrecht.