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Tools & Downloads

Certification

Explore detailed information about the Certification step of the innovation circle. Discover short articles, relevant websites, and downloadable hand-outs. Click the heart icon to save these components to your personal page.

Ethical Committee Finder

This convenient tool can help you find a suitable committee or other organization to review your clinical trial application in the Netherlands.

Flowchart: Is your software a Medical Device?

Guidance on the certification process at notified bodies regarding the European Regulations 'MDR' and 'IVDR' (Dutch)

This guidance for notified bodies is intended to assist start-ups/small and medium-sized enterprises (SMEs) in navigating the certification process and the procedures required by the MDR and the IVDR.

MDR - FAQ reader

What I wish I knew before I started with the MDR

MDR IVDR (Dutch)

Assess through the flowchart whether you require a CE certificate for the distribution of your software and if seeking certification from a notified body is necessary

Mutual Recognition Agreements

European companies that wish to export to Australia, Canada, Japan, New Zealand, the USA, Israel or Switzerland need to know about Mutual Recognition Agreements (MRAs) and the designated Conformity Assessment Bodies (CABs).

More information can be found on this website 

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