ГОСТ Р ИСО 14155-2022. Национальный стандарт Российской Федерации. Клинические исследования медицинских изделий, проводимые с участием человека в качестве субъекта. Надлежащая клиническая практика

[1]

ISO 10993 (all parts)

Biological evaluation of medical devices (Оценка биологического действия медицинских изделий)

[2]

ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (Медицинские изделия. Системы менеджмента качества. Системные требования для целей регулирования)

[3]

ISO 15223-1

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Медицинские изделия. Символы, применяемые при маркировании на медицинских изделиях, этикетках и в сопроводительной документации. Часть 1. Общие требования)

[4]

Software as a Medical Device (SaMD): Clinical Evaluation [IMDRF/SaMD WG/N41 FINAL: 2017], available at: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170921-samd-n41-clinical-evaluation_1.pdf

[5]

Global Harmonisation Task Force. Clinical Evaluation [SG5/N2R8: 2007], available at: http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n2r8-2007-clinical-evaluation-070501.pdf

[6]

Global Harmonisation Task Force, Essential Principles of Safety and Performance of Medical Devices [SG1-N41R9: 2005], available at: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-181031-grrp-essential-principles-n47.pdf

[7]

Declaration of Helsinki available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

[8]

MEDDEV 2.7.1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, available at: http://ec.europa.eu/growth/sectors/medical-devices/guidance/index_en.htm

[9]

Design considerations for pivotal clinical investigations for medical devices - guidance for industry, clinical investigators, institutional review boards and Food and Drug Administration staff, November 7, 2013, available at: https://www.fda.gov/media/87363/download

[10]

Exemptions I.D., (IDEs) for early feasibility medical device clinical studies, including certain first in human (FIH) studies, guidance for industry and Food and Drug Administration staff, October 1, 2013, available at: https://www.fda.gov/training-and-continuing-education/cdrh-learn/transcript-ides-early-feasibility-medical-device-clinical-studies-including-first-human-fih-studies

[11]

Oversight of clinical investigations - A risk-based approach to monitoring, August 2013, available at: http://www.fda.gov/downloads/Drugs/Guidances/UCM269919.pdf

[12]

FDA guidance for industry; Electronic Source Data in Clinical Investigations; September 2013, available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm328691.pdf

[13]

MHRA Guidance on legislation; clinical investigations of medical devices - statistical guidance; September 2017, available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/645296/Statistical_considerations_-_September_2017.pdf

[14]

IMDRF/REGISTRY WG/N33 FINAL:2016 'Patient registry; Essential Principles' registry system', available at: http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-essential-principles-151124.pdf

[15]

IMDRF/Registry WG/N42 FINAL:2017 'Methodological Principles in the Use of International Medical Device Registry Data' (covering multiple applicable registries), available at: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-methodological-principles.pdf

[16]

Guideline on data monitoring committees, available at: https://www.ema.europa.eu/documents/scientific-guideline/guideline-data-monitoring-committees_en.pdf

УДК 006.83:006.354

ОКС 11.100.20

Ключевые слова: медицинские изделия, клинические исследования, надлежащая клиническая практика