Notification

The duty to notify (notification) of medical devices, active medical devices for implantation, medical devices for in vitro diagnostics, treatment systems and packs consisting of medical devices, hereinafter called the devices, is regulated by the provisions of the Act of 20 May 2010 on medical devices (Dz. U. [Journal of Laws] No 107, item 679 as amended).

In accordance with the requirements of Article 58 of the Act, the duty to notify the Chairman of the Office for Registration of Medicinal Products, Medical Devices and Biocides of the first case of marketing a medical device (not later than within 7 days of the date of marketing) applies to:

  • the distributor and importer residing or based in the Republic of Poland,
  • the service provider that evaluates the effects of the device in the Republic of Poland, when its producer and authorised representative are not based in the Republic of Poland.

In order to fulfil the above-mentioned obligations, KMJ pharma® Sp. z o.o. offers its clients services related to:

  • preparing the content of labels for medical devices (which is an element of the notification),
  • preparing and submitting necessary documents and supervising the notification process.