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 Laws of 20 May 2010). U. 2010, No. 107, item. 679 as of late. as amended). It should be borne in mind that active implantable medical devices, in vitro diagnostic medical devices or treatment systems and kits composed of medical devices are also subject to such an obligation.
Depending on the type of entity, the act requires them either to notify a medical device or to notify such a device, in both cases the Competent Authority is the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The notification, at least 14 days before the first placing on the market of the device or the transfer for evaluation of the performance, must be made by the manufacturer and an authorized representative established in the territory of the Republic of Poland. Similarly, within that period, the notification containing information on the activities carried out should also be made by an entity (established in the territory of the Republic of Poland) which, for the purpose of placing on the market as a system or treatment set, together juxtamises ce-marked medical devices without exceeding their intended use and the restrictions on use specified by their manufacturers or sterilizes a system, treatment kit or medical device marked with the CE mark , intended by its manufacturer for sterilization before use.
The law precisely defines what exactly should be included in such a notification, indicating that it contains, in particular:
(1) the name and address of the notouing entity;
(2) the trade name of the product;
(3) the generic name of the device;
(4) the name and address of the manufacturer;
5) a brief description of the product and its intended use, in Polish and English;
(6) the class of medical device and the classification rules applied;
(7) whether the in vitro diagnostic medical device is an A-listed device, a list B device, a self-control device, an performance assessment device or a new device;
(8) whether the device is a custom-made product;
(9) the number of the notified body which participated in the conformity assessment;
(10) the code of the device according to the Global Nomenclature of Medical Devices (GMDN) or other recognised nomenclature of medical devices together with the name of that nomenclature.
In addition, it is necessary to include in such a notification:
(1) the models of marking;
2) specimen instructions for use of the product – if they are supplied with the product;
3) designs of promotional materials – if they are supplied with the product;
(4) a declaration of conformity, a statement of the custom-made device, a statement of the device for performance assessment, a statement of the treatment system or kit, juxtamodised together with CE-marked medical devices, or a statement concerning the sterilisation of a CE-marked treatment device or medical device intended by its manufacturer for pre-sterilization;
(5) a list of laboratories or other bodies involved in the performance assessment of the device for performance evaluation;
(6) copies of certificates of conformity issued by notified bodies which have participated in the conformity assessment;
(7) a document confirming the payment of the application fee;
8) a copy from the National Court Register or an extract from the register of economic activities;
9) a copy of the document designating an authorized representative residing in the territory of the Republic of Poland;
10) a copy of the document confirming the identity and address of the place of residence – in the case of a natural person not doing business.
Another category of obligations laid down by the legislature for the placing on the market of a medical device is the appropriate notification to the President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products. To make it without delay, but no later than 7 days from the date of introduction of the first product into the territory of the Republic of Poland, the Act obliges in particular the distributor and importer residing in the territory of the Republic of Poland, who have introduced into the territory of the Republic of Poland a product intended for use in that territory. Also, a healthcare provider who, in the territory of the Republic of Poland, carries out an assessment of the performance of a device for the evaluation of an action, and whose manufacturer and authorized representative are not domiciled in our country, shall immediately notify the President of the Office, but this may not take place later than 7 days from the date of commencement of the performance assessment.
This notification should contain the following elements:
(1) the name and address of the notified entity;
(2) the trade name of the product;
(3) the name and address of the manufacturer;
4) the name and address of the authorized representative.
It shall also be accompanied by:
(1) the models of marking;
2) specimens of instructions for use of the product – if they are supplied with the product;
3) models of instructions for use of the product for the evaluation of the performance, the performance evaluation of which is to be carried out in the territory of the Republic of Poland – if they are supplied with the product;
4) models of promotional materials, which specify the intended use of the product intended for use in the territory of the Republic of Poland – if they are supplied with the product;
(5) information on the number or quantity of devices delivered for performance assessment and on the duration of the performance assessment;
(6) a document confirming the payment of the notification fee;
7) a copy from the National Court Register or an extract from the register of economic activities;
8) a copy of the document confirming the identity and address of the place of residence – in the case of a natural person not doing business.
Notifications and notifications shall be made on the relevant forms, which are located (together with the relevant instructions) on the http://www.urpl.gov.pl/wm-formularze.
photo source: www.sxc.hu