For obvious reasons, the Act of 20 May 2010 on Medical Devices (Journal of Medical Devices) U. of 17 June 2010, as amended. (zm.) imposes most of the obligations relating to the placing on the market and use of a medical device on the manufacturer or his authorised representative, who are also solely responsible for the operation of the device and any risks that arise from it. First of all, the manufacturer of the device is responsible for the device, for carrying out the conformity assessment of the device before it is placed on the market and for placing the device on the market. If he is not domiciled in a Member State, that responsibility shall be borne by the authorised representative for that product.
However, notwithstanding these obligations, the Act also regulates the appropriate liability of distributors and importers of medical devices. A "distributor" is defined as an entity established in a Member State that supplies or makes the product available after it has been placed on the market; and a healthcare provider who imports into the territory of Polish from the territory of another Member State a device intended for the provision of health services by that healthcare provider; whereas 'importer' is defined as an entity established in a Member State which places a product on the market outside its territory; and a healthcare provider who imports into the territory Polish from outside the Member States a device intended for the provision of health services by that healthcare provider.
It is the primary duty of both the importer and the distributor to act with due diligence to ensure the safety of the products. In particular, they may not supply or make available devices of which they know or of which, in accordance with their information and professional experience, they should know that they do not comply with the requirements laid down by law. They shall also be responsible for checking the correct marking and having appropriate instructions for use by the devices which they place on the market, put into service, supply or make available.
Another category of obligations established by the legislature for the distributor and importer (resident in Poland) of medical devices is of a registration nature and concerns the appropriate notification to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products about the placing on the market in the territory of Polish of a device intended for use in that territory. This shall be done without delay, but no later than 7 days after the date of introduction of the first product into the territory of Polish.
A variety of obligations relating to the safety of the medical device and the risks associated with its use have also been imposed on both entities resident or established in the territory of Polish. They have been required to participate in the safety activities of products which they place on the market, put into service, supply or make available, in particular:
(1) receiving information from users and patients on the risks posed by devices and transmitting them without delay to the manufacturer or authorised representative and to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;
(2) to store for at least 5 years from the date of delivery of the last device and to make available without delay, at the request of the President of the Office, the documentation necessary to establish the origin and unambiguous identification of the devices;
(3) to keep for the period of use of the device and to make available during the relevant checks provided for by the manufacturer and to make available without delay, at the request of the President of the Office, a list of all healthcare providers and distributors to whom they have supplied the devices;
(4) the implementation of the safety measures provided for by the manufacturer;
(5) ensure that, while they are responsible for the product, the conditions for its storage and transport do not adversely affect its compliance with the requirements laid down by law.
Importers and distributors of devices who, in the course of carrying out their activities, have identified a medical incident which has occurred in Polish must report it without delay to the manufacturer or an authorised representative and send a copy of such notification to the President of the Office, unless they have become concerned that the incident has already been notified to the manufacturer or to an authorised representative and the President of the Office. They shall also, in respect of their activities, also have the obligation to cooperate with the President of the Office, the manufacturer, an authorised representative or an entity authorised by the manufacturer to act on his behalf in matters of medical incidents and on matters relating to the safety of devices in order to avoid or eliminate the risks posed by devices which they place on the market, put into service, supply or make available. On the other hand, if they are in any way informed that a device placed on the market may be dangerous, they must immediately inform the President of the Office.
In addition, the Act also regulates additional obligations of the importer of medical devices. First of all, it is obliged to check before placing the product on the market whether:
(1) the manufacturer or authorised representative has carried out an appropriate conformity assessment procedure for the device;
(2) the manufacturer has appointed an authorised representative for the device;
(3) the device shall be marked with the CE mark as well as the identification number of the notified body which was involved in the conformity assessment, if the law so provides;
(4) the information supplied by the manufacturer meets the essential requirements.
Furthermore, an importer established in the territory of Polish must have and keep at least 5 years from the date of placing the product on the market, at the disposal of the President of the Office, the most important documentation relating to that product (including a copy of the declaration of conformity).
photo source: www.istockphoto.com