Medical devices | In Principle

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Medical devices

Regulated activity

Production and trade of medical devices is regulated in Poland by the Medical Devices Act of 20 May 2010. For the most part, the law implements EU legislation in this regard. Market authorisation for medical devices requires the fulfilment of certain conditions concerning the products (compliance with basic requirements and certification), but does not require separate permits for specific goods. A party entering a product into trade is nevertheless required to register the product in the register maintained by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL). Wholesale and retail trade in medical devices does not require a permit.

The quality of medical devices and fulfilment of statutory obligations on the part of producers and other participants in trade is subject to URPL control. URPL is entitled to intervene in business operations and issue decisions ordering certain actions or prohibiting certain actions or product sales.

All resolutions pertaining to the medical devices market are made through the issuance of administrative decisions. If an applicant or controlled entity is dissatisfied with a decision, it may appeal to the second-instance administrative authority. Thereafter, review of the administrative decision may be sought from the province administrative court, possibly followed by a cassation appeal to the Supreme Administrative Court.

Clinical trials

In Poland, clinical trials of medical devices are supervised by URPL and require an administrative permit and entry in the register of clinical studies.

Patent protection

Patents pertaining to medical devices are registered at the Polish Patent Office. All proceedings for patent registration or invalidation are conducted before the Patent Office by patent attorneys. Disputes arising from patent infringement, including claims to cease and desist and for damages, fall under the jurisdiction of the common courts, civil and commercial.