InnovetDirect
Scherpenzeel, Netherlands
InnovetDirect is a Scherpenzeel-based manufacturer of veterinary disposables and private-label products.
Business types in Scherpenzeel
Regulation in the Netherlands
Netherlands is in the EU / EEA, so the EU framework applies.
Regulator: European Commission (DG SANTE) with national competent authorities of EU/EEA Member States
Two EU regulations govern medical devices and IVDs in the EU/EEA; devices need CE marking after the conformity assessment route set by their risk class.
From the sourced EU MDR / IVDR entry, checked 29 October 2026. General information, not legal advice. Requirements for Netherlands · All medical certifications
Frequently asked questions
What should I verify if a Dutch company offers to be my EU authorized representative?
Before signing, check that the company:
- is established in the EU and will sign a written mandate covering the tasks in Article 11 of the EU MDR;
- has a person responsible for regulatory compliance (PRRC) available, as Article 15 requires;
- is registered, or will register, as an authorized representative in EUDAMED and can give you its Single Registration Number;
- is clear about whether it will also be your importer, which is a separate role with its own duties.
The authorized representative's name and address go on your labeling, so changing it later means relabeling. See the Netherlands country page.