Online sales of medical devices controlled
In recent years, we have seen a dynamic increase in online sales of medical devices. The electronic distribution channel for medical devices remained out of…
Regulation of the Minister of Health on the model order for the supply of medical devices and the model repair order
Please note that as of 1 July 2014, it is necessary to use new order templates for the supply of medical devices and models of…
UOKiK's position on unauthorised sales practices of distributors of medical devices
7 August 2014 The Office of Competition and Consumer Protection (UOKiK) issued a decision ordering Mat-Medic, a company selling paramedical products, to refrain from unauthorised…
Entrepreneurial, what to choose? –problems with the legal classification of 'borderline' products
The average consumer does not consider the type or legal classification of a particular product when purchasing a particular product. The main factors influencing its…
Medical device or dietary supplement… here's the question!
The observed situation on the market of products with, according to the assurances of manufacturers, the beneficial effect on human health or well-being is increasingly…
Clinical trials of medical devices – communication from the President of the URPL
The issue of conducting clinical trials of medical devices was the subject of a communication from the President of the Office for the Registration of…
Interpretation of the definition of a medical device
The recent judgment of the Court of Justice of the European Union (hereinafter referred to as the EU TS) of 22 November 2012 in Case…
Eudamed evaluation
Since 1 May 2011, the introduction of relevant information on medical devices into the European Eudamed database has become mandatory in all Member States of…
Innovation in the product sector – Council conclusions
The importance of innovative solutions in the pharmaceutical industry is needed and desirable as in any other sector, as they can translate directly into improving…
Essential requirements
It is the responsibility of the manufacturer or his authorised representative to ensure that medical devices comply with the essential requirements laid down for each…