SSSponsor object

Sponsor - Definition available in national law

Yes

Sponsor - Definition (pursuant to national law)

Manufacturer (Sponsor) according to Art 1(d) Medical Devices Decree (Dutch):
“The person, legal entity, or the authorised representative of that person, who:
is responsible for the design, manufacturing, packaging and labeling of a medical device with the aim of marketing said device under one’s own name, regardless of whether these actions are carried out by one and the same person or under the responsibility of a third party; or
assembles, packages, processes, updates or labels one or more prefabricated products, or who assigns these products as a medical device with the aim of marketing said device under one’s own name.”

Sponsorship mandatory

Yes

Co-Sponsor - Definition available in national law

No

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