Discover the 6 Steps to Successfully Obtain CE Certification

If you’re developing a medical or in vitro diagnostic device, obtaining the CE mark is essential to enter the European market. Here are the key steps:

Classification: Determine the classification of your device (I, IIa, IIb, III for medical devices; A, B, C, D for IVDs).

Risk Assessment: Conduct a safety and efficacy analysis, documenting clinical studies or scientific evidence.

Technical Documentation: Prepare complete documentation according to European directives, including details on design and intended use.

Notified Body: Involve an independent entity to assess compliance through audits and reviews.

Declaration of Conformity: Issue a document certifying that your device meets applicable standards, allowing for the application of the CE mark.

CE Marking: Apply the mark and begin commercialization, keeping files updated and ensuring post-market surveillance.

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