The EU is one of the most attractive markets for medical device and IVD sales. UL’s Notified Body toolkit provides 34- pages of information on the EU regulatory system, including the classification rules, process for approvals and conformity assessment procedures. It also is a valuable reference document, with links to guidance documents, Interpretive documents and trade associations.

Download your copy of our latest update today, which includes information on revised clinical evaluation criteria, and specific mention of the DOCOPOCOSS and IEC 60601 3rd edition. For more information on UL’s Notified Body for EU CE IVD and Medical Devices, refer to our contact button.

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