Changes in EU law
On 26 September 2012 The European Commission has put forward proposals for two regulations aimed at improving the safety, efficacy and innovation of medical devices….
Reporting medical incidents
As in the case of medicinal products, the EU legislature has placed great emphasis on minimising the risks associated with the use of a medical…
Marking of a medical device
The General Directive on the information to be included in each medical device indicates that it is information needed for the safe and proper use…
Taxation of additional elements
There is a lot of controversy and doubt about the proper taxation of additional elements (goods and services) on medical devices. A key role in…
Ce
Medical devices are only one of the many product groups on which the CE mark is affixed. This designation was regulated under Union law as…
Conformity assessment procedure
Depending on the class of medical device, the manufacturer may choose the procedure for assessing the conformity of the device. The various procedures are governed…
Instructions for use
The instructions for use of the medical device and its marking shall consist of a set of information necessary for the safe and proper use…
Registration of medical devices
The obligation to report and notify medical devices is regulated by the provisions of the Act of 20 May 2010 on Medical Devices (Journal of…
Choice of tax rulings
Issues relating to the application of the appropriate VAT rate for medical devices are a frequent subject of interpretation of tax legislation in individual cases…
Medical device and medicinal product
In practice, the classification of a product as a medical device may raise significant doubts. In particular, this applies where it is unclear whether a…