Medical Device Registration and Approval in Poland

General country-specific regulatory information is provided on this page for medical device registration and approval in Poland. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Poland, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Poland

REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. The Polish Ministry of Health (MOH) must also be notified of all medical and IVD devices which are marketed in Poland.

CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb, III, and IV.

TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.

LICENSE VALIDITY: Licenses issued in the EU are valid for five years.

AUTHORIZED REPRESENTATIVE: An authorized representative anywhere in the European Union is required to obtain the CE mark. Only entities with a registered place of business in Poland can make notifications of medical devices to the Polish MOH.

ADDITIONAL INFORMATION: The Medical Device Directive is due to be changed in 2015.

Last updated on March 17 2015.

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