On-Demand Webinar | Routes to EU Market Access

In this webinar, Keith discussed that when we work with our clients, we sometimes see them mix up the roles and responsibilities of:

The legal manufacturer
A manufacturing site
A distributor (when they distribute someone else’s medical device(s)
Procedure packer

Having a good understanding of these is essential to ensure an organization complies with all requirements, but perhaps even more importantly is vital so one can make informed choices as to the pros and cons of the various paths one may have to get a product to market and what role the organization wants to (and is able to) take, based on the details of the situation.

During the session, Keith answered many questions that we consistently get asked from Medical Device manufacturers and our clients:

When is an organization the legal manufacturer?
What are the responsibilities of the legal manufacturer?
What can a legal manufacture delegate to others?
What are the requirements for a legal manufacturer vs a manufacturing site vs a distributor vs a PPP (and hence how can you apply the one(s) that work best for your situation?

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Keith Morel, PhD

Post date: July 13, 2021