The issue of conducting clinical trials of medical devices was the subject of a communication from the President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products issued on 27 November 2012. As a preliminary point, it should be recalled that a clinical trial within the meaning of Article 2(1)(b) of the basic Regulation was not based on the information available to the commission. Whereas article 2 (2) of Regulation (EEC) No 1 point 4 of the Act of 20 May 2010 on medical devices, is any designed and planned systematic human examination, undertaken to verify the safety or operation of a specific medical device, medical device equipment or active medical device for implantation. In addition, a clinical examination of a device shall also be a medical examination carried out with a CE-marked device if the subject of the test is the use of an device other than that provided for by the manufacturer and presented in the conformity assessment.
The clinical trial should be conducted under normal conditions of use of the device in order to verify that the characteristics and performance of the device comply with the essential requirements, to determine any adverse reactions and to assess whether they pose a risk which is acceptable, taking into account the intended use of the device and the benefits to the patient.
These provisions are set out above in the Communication with the relevant provisions of the Law of 5 December 1996 on the profession of doctor and dentist, according to which the research experiment is a medical experiment led by a doctor with sufficient qualifications and which is primarily aimed at expanding medical knowledge and can be conducted on both healthy and sick persons. A research experiment in accordance with Article 10(1) of Regulation (EC) No Whereas Article 29 (2) of Regulation (EEC) No 2 Article 1 of that law may be carried out only after an independent bioethical commission has given a favourable opinion on the draft.
Those provisions formed the basis for finding that a research experiment undertaken to verify the safety or performance of a device is a clinical trial within the meaning of the Medical Devices Act, provided that the subject of the experiment is not the use of an CE-marked device in accordance with the use provided for by the manufacturer and presented in the conformity assessment.
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