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Product registration is a necessary step before placing the product on the EU market.

Product registration is a mandatory step before placing any medical device on the European market to ensure legal compliance and market access. This process is designed to enhance transparency and harmonize market surveillance across all EU Member States.
From preparation to market access:
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Actor registration: Obtaining a Single Registration Number (SRN) to identify the manufacturer and other economic operators.
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Compliance preparation: Determining the device class and appointing an Authorized Representative and Notified Body (if required).
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Conformity confirmation: Preparing the technical documentation and signing the Declaration of Conformity.
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UDI assignment: Assigning the Basic UDI-DI and generating specific UDI-DI codes.
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Product registration: The final step of entering the device data into EUDAMED database to legally enable market placement.
Placing a device on the market is done based on the Declaration of Conformity and the Certificate of Conformity issued by a Notified Body (if applicable). However, full registration in EUDAMED is a legal prerequisite for maintaining market access in the EU.

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