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Regulatory Strategies for Medical Devices – Masterclass series

Regulatory Strategies for Medical Devices – Masterclass series 


This masterclass series offers a practical introduction to the regulatory process for medical devices and the early decisions that can affect documentation, timelines, costs, and market access. It is relevant for companies at different stages — whether they are just getting started, already engaging with a Notified Body, or preparing to go through the process again. 


Read more about the three masterclasses down below or on our website: Masterclass 1, Masterclass 2 and Masterclass 3


NB: This activity is delivered as part of Danish Life Science Cluster’s EU project Erhvervsfyrtårn Life Science and is provided as state aid under the de minimis Regulation for participating companies. The state aid is calculated at DKK 6,000 for all three masterclasses. Participation requires signing the relevant documentation and registering time spent. Participants are expected to spend approximately 10 hours per masterclass on preparation, participation, and follow-up.  
The event is co-funded by the European Union and the Danish Board of Business Development and is delivered in collaboration with Pharma4ever. 

Skemalagte aktiviteter

Dato
Titel
23-04-2026
13.00 - 14.00
Masterclass 1: The Hidden Road to Market: Understanding the Regulatory Pathway
23-04-2026
13.00 - 14.00
Aktiviteten foregår online.

Underaktivitet

Regulatory Strategies for Medical Devices – Masterclass series
Masterclass 1: The Hidden Road to Market: Understanding the Regulatory Pathway
Masterclass #1

Program:
13.00 – 13.20 The Regulatory Pathway
- Specification of the “Intended Purpose”
- Product categorization
- Device type & Classification
- Specific compliance requirements
- The difference between the European and US pathways
13.20 – 13.35 Critical Early Decisions
- The design verification activities (performance evidence)
- The design validation activities (users)
13.35 – 13.45 How regulatory strategy should influence product development
- Can you downgrade the criticality of your device?
13.45 – 14.00 Notified Body – Is it a Partner or an Opponent?
- Choice of Notified Body
- Involvement of the Notified Body
- Planning of the certification process
14.00 – 14.10 Questions & Program Masterclass #2

Participants will gain insight into: 

- the overall regulatory journey from prototype to market access 
- differences between the European and US regulatory approaches 
- early decisions that affect timelines, costs, and the likelihood of successful approval 
- when and how a Notified Body should be involved 
- how collaboration with a Notified Body works in practice
23-04-2026 13.00
23-04-2026 14.00
Aktiviteten foregår online. Link oplyses før start.
20-05-2026
13.00 - 14.00
Masterclass 2: When requirements meet the product: what you need to have in place
20-05-2026
13.00 - 14.00
Aktiviteten foregår online.

Underaktivitet

Regulatory Strategies for Medical Devices – Masterclass series
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. 

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
20-05-2026 13.00
20-05-2026 14.00
Aktiviteten foregår online. Link oplyses før start.
18-06-2026
13.00 - 14.00
Masterclass 3: When Approval Becomes the Tough Part: What You Need to Know About Notified Bodies, Documentation, and Market Access
18-06-2026
13.00 - 14.00
Aktiviteten foregår online.

Underaktivitet

Regulatory Strategies for Medical Devices – Masterclass series
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.

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
18-06-2026 13.00
18-06-2026 14.00
Aktiviteten foregår online. Link oplyses før start.

Information

Tilmelding slutter
18-06-2026 10.24
Start tilmelding

Kontaktperson

Krestian Borring

Projektleder
Danish Life Science Cluster

51510466