Application

The duty to report 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 at least 14 days before the first case of marketing a medical device or sending its effects for evaluation applies to:

  1. The producer and authorised representative residing or based in the Republic of Poland
  2. The entity residing or based in the Republic of Poland that conducts business activity involving:
  • putting together treatment systems and packs with the use of medical devices having an EC label,
  • sterilizing treatment systems and packs that consists of medical devices having a EC label,
  • sterilizing medical devices having an EC label, the sterilization of which is advised by their producers.

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.