It is useful to know that in certain situations a mandatory notification or notification concerning, in principle, the placing on the market of a medical device or its transmission for performance assessment, in accordance with the Act of 20 May 2010 on medical devices (Journal of Laws of 20 May 2010). U. 2010, No. 107, item. 679 as of late. more than one product may be covered. In order for a group of products which differ in trade name, type, model, version of workmanship, software version, size, shape or dimensions to be considered as a single product, the following conditions must be met together. These products should have:
· one manufacturer,
· one authorised representative if their manufacturer is not established in a Member State,
· a single, common brief description of the device and its intended use,
· one generic name as detailed as possible,
· one device code according to the Global Nomenclature of Medical Devices (GMDN) or other recognised nomenclature of medical devices,
· the same classification or qualification,
· a joint conformity assessment carried out according to the same conformity assessment procedures,
· a common certificate or common certificates of conformity where notified bodies have been involved in the assessment of their conformity,
· in the case of notification of a product – no more than one trade name in Polish and English/ and in the case of notification of a product – one reference number in the EUDAMED database and one trade name in Polish or one trade name in English.
On the other hand, systems or treatment kits of the same purpose, compiled by the same operator and containing the same medical devices which, in different systems or treatment sets, come in different quantities or differ in trade name, type, model, version of workmanship, software version, size, shape or dimensions may be considered as a single system or treatment set if the corresponding medical devices in each treatment system or set can be considered as a single device , in accordance with the above criteria.
In such a situation, the relevant entity shall be entitled to place the product group on a single application or on a single line of the notification form. This issue is relevant to the level of fees associated with notification or notification to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The amount of the fee depends on the number of products, and the regulations set it at PLN 30 per product (number of notifications). The fee (separately for each product, together with the ID number in the footer of form No 1) must be paid into the Office's account, indicating in the title of the transfer/fees generated on form No 1 the ID number.