Borderline Products

If you are in any doubt about the qualification of a product and in need of an expert opinion as to whether or not it constitutes a medical device, the State Institute for Drug Control (henceforth “the Institute”) may be asked to issue an expert opinion or decision in this respect. In addition to the assessment of the qualification of the product, you can also ask the Institute to assess the classification of the device, based on the provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices or Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices on risk classification.

To apply for the assessment referred to hereinabove, please use the following forms:

– If you assume that your case concerns:

A) a medical device: Application for Borderline Product Assessment or Device Classification
B) a medicinal product: Application for a decision whether a product is classified as a medicinal product