Supervision of medical devices

In view of the need to protect public health and to address the risks that may arise from the use of a medical device, and to ensure the safety of patients, users or other persons in contact with devices, the Medical Devices Act of 20 May 2010 (OJ C 104, 11.12.2010, p. 1). U. of 17 June 2010, as amended. zm.) has granted the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products certain powers in the supervision of devices manufactured, placed and placed on the market, used or delegated for evaluation of performance in the territory of Polish.

Within the framework of the supervision exercised, in the field of supervision of the quality, safety and free circulation of medical devices, the President of the Office cooperates with the entities specified in the Act (among others. The Chief Pharmaceutical Inspector, the President of the National Health Fund, the Agency for The Evaluation of Medical Technologies, the Chief Veterinary Officer, the President of the Office of Competition and Consumer Protection, the Quality Monitoring Centre in Health Care), which are also obliged to notify him of the irregularities found concerning the devices.

Among the supervisory powers of the President of the Office, the following groups of powers can be distinguished in particular:

(1) keeping, updating, making available data, recording and issuing certificates of entry in the Register:

(a) medical devices and entities responsible for their placing on the market or use,

(b) medical devices used in veterinary medicine and those responsible for their placing on the market or use,

(2) collecting and analysing information on the safety of devices;

(3) inspection of manufacturers, authorised representatives, importers, distributors, operators juxtamodating medical devices into treatment systems or kits, operators sterilising medical devices, systems and treatment kits for placing on the market, as well as subcontractors established in the territory of Polish. This check shall include:

(a) the design, manufacture, packaging, marking, storage, distribution, assembly, processing and complete reproduction of the device;

(b) presenting the product at trade fairs, exhibitions, shows, presentations and scientific and technical sympoposiums;

(c) the making of the intended use to the device;

(d) sterilisation before placing on the market or for use;

(e) the assembly of medical devices into treatment systems or kits;

(f) carrying out the examination and final inspection of the device;

(g) the placing on the market, marketing and putting into service of the products.

(4) the issue of administrative decisions in respect of a product or group of products:

(a) to subject to specific requirements, to prohibit, suspend or restrict the placing on the market, entry into service, launch or use of the devices in concerned, their withdrawal from the market or use, or the obligation to take the FSCA or issue a safety note;

(b) the withdrawal from the market, withdrawal from the market and use, prohibition or restriction of the placing on the market or use of CE marked devices or custom-made devices, properly installed, maintained and used in accordance with their intended use, where they may endanger the life, health or safety of patients, users or other persons;

(c) withdrawal of the device from the market; withdrawal of the device from the market and from use; prohibit or restrict the placing on the market of a device or a device for use if, contrary to the provisions of the Act, the CE mark is a product or, contrary to the provisions of the Law, the CE mark is not a product and the infringement has not been rected within the prescribed period after a request by the President of the Office to do so.

(d) the resolution of disputes between the manufacturer and the notified body as regards doubts as to the classification of medical devices, active implantable medical devices or the qualification of in vitro diagnostic medical devices,

(e) the removal of markings or inscriptions which could mislead as to the marking of the CE mark or the identification number of the notified body, from the product or article, its packaging or instructions for use.

Furthermore, where justified by the need to protect the life or health of patients and users and the need to protect public health, the President of the Office may also carry out checks on:

1) the device, its documentation and conditions of use of the device by the healthcare provider or conduct an assessment of the performance at the place of use or perform an performance assessment,

(2) entities carrying out activities relating to the installation, maintenance, maintenance, servicing, adjustment, calibration, calibration, inspection, repair or periodic safety check of the devices, at the place of performance of those operations and at the place of residence or premises of the entities performing them.

In addition, the President of the Office shall have the right to request, for 2 years from the date of notification of the new device, the presentation by the manufacturer or an authorised representative of a report on the experience gained after the new device has been placed on the market.

It should also be mentioned that the above-mentioned supervisory powers should be considered together with the other powers of the President of the Office, which are related, inter alia, to the supervision of medical incidents and activities in the field of safety of medical devices, medical devices equipment, in vitro diagnostic medical devices, in vitro diagnostic medical devices, active implantable medical devices and treatment systems and kits; classification of medical devices or conducting clinical trial inspections.


KONDRAT Law Firm and Partners

biuro@kondrat.pl


photo source: www.sxc.hu

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