Medical devices and in vitro diagnostic devices are present in almost all aspects of life. As the world develops and is driven by technology, medical devices and related technologies also evolve. These evolving technologies have led to significant advances in modern medicine, but the result is that they are increasingly difficult to implement from a legal point of view. The manufacturer of medical devices should be confronted with a number of legal requirements – the current Directives 93/42/EEC, 98/79/EC, the new MDR/IVDR regulations, as well as harmonised standards (notably ISO 13485, ISO 14791, ISO 10993) which require considerable knowledge and experience in order to be properly interpreted and implemented.

Food supplements, as well as foodstuffs for special medical purposes, have a very high market share, due to the accelerated registration process. Many products from the borderline of medicinal products or medical devices are marketed as dietary supplements. A conscious presentation of the product, information about it and labelling can have a significant impact on qualification.

Personal protective equipment protects its users from mechanical injuries to different parts of the body. These products are the basic protection of an employee and protection against potential hazards, so they should be checked in terms of: design, harmlessness, comfort and effectiveness, information from the manufacturer and other specific requirements depending on the purpose. The placing on the market of such products is associated with the assessment of compliance with Regulation 2016/425.

This is where we start as MDR Regulator, experienced consultants who will help you with all matters concerning the regulation and compliance of your product.

Medical products

Medical devices benefit patients and users by helping to diagnose and treat patients and to prevent diseases, improving quality of life.

In vitro diagnostic medical devices

In vitro diagnostic medical devices, by examining a sample of tissue or body fluids, effectively and safely diagnose a number of diseases or conditions.

Dietary supplements

Dietary supplements in Polish regulations are significantly different from medicinal products, which affects their scope of application and restrictions.