It is the responsibility of the manufacturer or his authorised representative to ensure that medical devices comply with the essential requirements laid down for each type of medical device in the relevant Union legislation so that they can be placed on the market and used.
The essential requirements are a set of different requirements, both general and specific, relating primarily to the safety, design and implementation of a medical device and to reducing or eliminating the risks associated with its use.
Act of 20 May 2010 on Medical Devices (Journal of Laws) U. of 17 June 2010, as amended. (zm.) contains an order for medical devices to comply with the essential requirements relating to them. For the placing on the market and use of custom-made devices which are active implantable medical devices or class IIa, IIb or III medical devices, the manufacturer or his authorised representative shall attach a statement issued after carrying out the appropriate conformity assessment procedure for the device concerned and confirming that the device complies with the essential requirements relating therein, or indicating which of the essential requirements have not been met , giving reasons.
The specific essential requirements for medical devices are contained in the Regulation of the Minister of Health of 12 January 2011 on essential requirements and procedures for assessing the conformity of medical devices (Journal of Laws and Regulations). 24 January 2011). Similarly, the requirements for special purpose medical devices are regulated by the Regulation of the Minister of Health of 12 January 2011 on the essential requirements and procedures for assessing the conformity of active implantable medical devices (Journal of Laws and Regulations). U. of 24 January 2011) and the Regulation of the Minister of Health of 12 January 2011 on the essential requirements and procedures for assessing the conformity of in vitro diagnostic medical devices (OJ C 104, 11.12.2011, p. 1). 24 January 2011). General requirements (Annex 1 to the Regulation) include:
(1) the need to design and manufacture medical devices so that their use under the prescribed conditions and in accordance with the intended use does not endanger the health and safety of patients, users and other persons. The risks associated with the use of a medical device in accordance with the intended use may be authorised provided that the benefits of its use prevail in the patient and that the devices provide a high level of safety and health protection. These requirements shall include in particular:
(a) reducing, as far as possible, the risk of utility error by using the ergonomic characteristics of the medical device and the environmental conditions in which it is intended to be used, i.e. design for patient safety;
(b) taking into account the technical knowledge, experience, education and training and, where relevant, the health and physical condition of the intended users, i.e. the specific design of medical devices for professional users, non-professional users, persons with disabilities and other users;
(2) the design and design of the device adopted by the manufacturer must comply with safety rules, taking into account the state of the art. When choosing the most appropriate solutions, the manufacturer shall apply the following rules in turn:
(a) eliminating or reducing risks as far as possible (safety resulting from design and construction);
(b) the application of appropriate protective measures, including, where necessary, alarms in the event of an unassid risk;
(c) informing users of the residual risk, which is remaining despite the application of protective measures;
(3) the need for the device to achieve the performance parameters provided for by the manufacturer and their designed, manufactured and packaged in a manner appropriate to the functions of the medical device specified by the manufacturer;
(4) the above characteristics and performance of the device must not deteriorate to such an extent as to cause the health and safety of patients and, where applicable, other persons to be endangered during the period of use of the medical device indicated by the manufacturer if it is subject to loads which may occur under normal conditions of use;
(5) the need to design, manufacture and packaging devices in such a way as to prevent deterioration of their performance during intended use, by means of transport and storage, taking into account the instructions and information given by the manufacturer;
(6) the assessment of the conformity of a medical device with the essential requirements must take into account that:
(a) the risk of adverse reactions must be acceptable, taking into account the intended performance of the medical device;
(b) the demonstration of compliance with the essential requirements must include a clinical assessment.
In addition to the general requirements, the above-above Regulation also contains essential requirements for the design and manufacture of a medical device (e.g. its chemical, physical and biological, structural and environmental characteristics).
It should be noted that medical devices enjoy a presumption of conformity with the essential requirements in so far as they are found to comply with:
1. the relevant national standards adopted on the basis of the standards published in the C series of the Official Journal of the European Union, as standards harmonised with the Directive:
(a) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active-deposition medical devices (OJ C 133, 11.12.1990, p. 1). Office of The EC L 189, 20.07.1990, p. 17; Coll. Office of The EU Polish special edition, chap. 13, t. 10, p. 154) – in the case of active implantable medical devices;
(b) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ C 133, 11.12.1993, p. 1). Office of The EC L 169, 12.7.1993, p. 1; Coll. Office of The EU Polish special edition, chap. 13, t. 12, p. 82) – in the case of medical devices and medical devices;
(c) 98/79/EC of the European Parliament and of the Council of 27 October 1998 on medical devices used for in vitro diagnosis (OJ C 133, 11.12.1998, p. 1). Office of The EC L 331, 07.12.1998, p. 1; Coll. Office of The EU Polish special edition, chap. 13, t. 21, p. (319) – in the case of in vitro diagnostic medical devices and in vitro diagnostic medical devices.
2) with monographs of the European Pharmacopoeia or their translations into Polish language contained in the Polish Pharmacopoeia, in the case of medical devices and active medical devices for implantation,
(3) with the common technical specifications set out in the Decision of the European Commission for in vitro diagnostic medical devices.
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