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

followed by networking drinks

Netherlands, Europe

Utrecht (exact location tbd)

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

Programme

The programme is currently under development and will be announced shortly.

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

Do you want to strengthen your understanding of regulatory approval and its impact on international growth? Register now to join the Health Holland Masterclass on 5 November.

We look forward to welcoming you in Utrecht.

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