Regulatory Pathways for Medical Devices – Master Class Series 2
Many strong medical device solutions face unnecessary delays — not because the technology is weak, but because key regulatory decisions are made too late or without a clear strategic foundation. This masterclass gives you insight into the regulatory process for medical devices and the early decisions that can have a major impact on timelines, costs, and market access.
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 2: When Requirements Meet the Product: What You Need to Have in Place
Once the overall regulatory pathway is clearer, the next question quickly becomes: What do authorities actually expect from your company and your product?
This masterclass provides a practical introduction to the key regulatory requirements for medical devices in Europe. Participants will gain a better understanding of how requirements vary depending on product type and risk class, and what that means in practice for development, documentation, and planning.
The session focuses on making the requirements more manageable and easier to work with in practice. The aim is not only to understand the legislation, but also to translate it into concrete development steps and a more structured approach to compliance.
Participants will gain insight into:
- how medical devices are classified, and why classification matters
the general requirements that apply to manufacturers - additional requirements that may apply to specific product types, such as sterile products or software
- the key documentation elements that typically need to be in place
Participants will receive:
- an overview of the documents required under European legislation
- guidance related to sterilisation
- a template for working with the key safety and performance requirements
Read about: Masterclass 1: The Hidden Road to Market: Understanding the Regulatory PathwayRead about: Masterclass 3: Approval in practice: Notified Bodies, documentation, and market access
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.