Regulatory Pathways for Medical Devices – Master Class Series 3

This masterclass series provides a practical and structured introduction to regulatory approval for medical devices. The programme is designed for startups, innovators, and development teams looking for a clearer and more strategic route through regulatory requirements, authority expectations, and collaboration with Notified Bodies.

The series is relevant for companies at different stages — whether they are just getting started, already in dialogue with a Notified Body, or preparing to go through the process again with a new product or market focus.

The masterclass series is delivered in collaboration with Pharma4ever and taught by Søren Lyngsø-Petersen and Pavla Frey. Together, they bring nearly 60 years of experience from the medical device field and strong practical insight into the regulatory requirements, processes, and decisions that shape the path to market.

The masterclass series is conducted in English.

Participants will gain insight into:

• how the regulatory process is structured in Europe — with a strategic perspective on the US
• which requirements authorities and Notified Bodies actually work from
• which early decisions influence development, documentation, costs, and approval chances
• how regulatory strategy can support development, investor dialogue, and commercialisation

Masterclass 3: When Approval Becomes the Tough Part: What You Need to Know About Notified Bodies, Documentation, and Market Access 

For many medical device companies, the approval stage is the most demanding part of the regulatory journey. This masterclass focuses on the part many teams find most challenging: how authorities and Notified Bodies actually evaluate your device and your documentation. 

The session provides practical insight into the approval process and into how the review process with a Notified Body typically works in Europe. It focuses on what authorities expect to see in the documentation, which issues most often lead to delays, and what should be considered early if the path to market is to be more robust and predictable. 

The masterclass also addresses an important strategic question for many companies: whether, in some cases, there may be a faster route to market through the United States before Europe. The aim is not to point to one right path, but to give participants a better basis for assessing their options and working more strategically with both approval and market access. 

Participants will gain insight into: 

• how the review process with a Notified Body typically works in Europe 
• what authorities and Notified Bodies expect to see in the documentation 
• which issues most often delay approval 
• what should be considered from the beginning of the regulatory journey 
• how Europe and the US may represent different routes within an overall market strategy 

Participants will receive: 

• an overview of the key documentation areas authorities focus on 
• insight into core documents such as clinical evaluation, risk management, biological evaluation, and post-market surveillance 
• a stronger foundation for working strategically with approval and market access 

Read about: Masterclass 1: The Hidden Road to Market: Understanding the Regulatory Pathway

Read about: Masterclass 2: When requirements meet the product: what you need to have in place

Practical information and funding

For companies, participation is provided as state aid under the de minimis regulation within the framework of Erhvervsfyrtårn Life Science. Participation requires signing the relevant documentation and registering time spent.

The event is co-funded by the European Union and the Danish Board of Business Development and is delivered in collaboration with Pharma4ever.