open access

Vol 15, No 1 (2020)
Cardiology and law
Published online: 2020-02-27
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Observational studies in cardiosurgical devices in light of Regulation 2017/745 on medical devices, and the provisions of Polish law

Oskar Luty
DOI: 10.5603/FC.2020.0010
·
Folia Cardiologica 2020;15(1):80-83.

open access

Vol 15, No 1 (2020)
Cardiology and law
Published online: 2020-02-27

Abstract

Act will replace national regulations that are based on the current system of medical devices directives (“MDD”). The Act on Medical Devices currently in force will be repealed and replaced by a new Act (the draft is currently being consulted). The new regulations will change the conditions for observational, non-interventional studies in which medical devices are used as intended by the manufacturer (in-label). Today’s law provides for a liberal approach to this type of studies, but from May 2020 they will be treated like full clinical trials, except for the obligation to obtain administrative permission. The article describes this problem and also provides arguments supporting the thesis that such research will not require the prior opinion of the bioethics committee.

Abstract

Act will replace national regulations that are based on the current system of medical devices directives (“MDD”). The Act on Medical Devices currently in force will be repealed and replaced by a new Act (the draft is currently being consulted). The new regulations will change the conditions for observational, non-interventional studies in which medical devices are used as intended by the manufacturer (in-label). Today’s law provides for a liberal approach to this type of studies, but from May 2020 they will be treated like full clinical trials, except for the obligation to obtain administrative permission. The article describes this problem and also provides arguments supporting the thesis that such research will not require the prior opinion of the bioethics committee.
Get Citation

Keywords

medical devices, clinical evaluation, clinical trial

About this article
Title

Observational studies in cardiosurgical devices in light of Regulation 2017/745 on medical devices, and the provisions of Polish law

Journal

Folia Cardiologica

Issue

Vol 15, No 1 (2020)

Pages

80-83

Published online

2020-02-27

DOI

10.5603/FC.2020.0010

Bibliographic record

Folia Cardiologica 2020;15(1):80-83.

Keywords

medical devices
clinical evaluation
clinical trial

Authors

Oskar Luty

References (15)
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