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List of International Standards & National Regulations & Guidances

International

ISO Standards

Standard Edition Title/Notes
ISO 13485 2016 Medical devices — Quality managementsystems — Requirements for regulatory purposes
ISO 14971 Third edition 2019-12 Medical devices - Application of risk management to medical devices
EN ISO 14971 43830 EN ISO 14971:2019/A11:2021 - Medical devices - Application of risk management to medical devices (ISO 14971:2019) + A11:2021
ISO/TR 24971 43983 Medical devices — Guidance on the application of ISO 14971
ISO/TR 20416 44013 Medical Devices - Post-Market Surveillance For Manufacturers
BS EN ISO 17100 43132 Translation services. Requirements for translation services (BS EN ISO 17100:2015+A1:2017)
ISO 19011 43282 Guidelines for auditing management systems
ISO 20417 2021-04 Medical devices — Information to be supplied by the manufacturer
EN ISO 15223-1 44593 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223­1:2021)
ISO 15223-1 44378 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
ISO 15223-2 40179 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
IEC 62304 Edition 1.1 2015)
EN 62304:2006 + Cor.:2008 + A1:2015 2015-06 Medical device software – Software life cycle processes
IEC/TR 80002-1 2009-09 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software: Ed 1
ISO/TR 80002-2 2017-06 Medical device software -- Part 2: Validation of software for medical device quality systems: Ed 1
IEC/TR 80002-3 2014-06 Medical device software - Part 3: Process reference model of medical device software life cycle processes: Ed 1
IEC 82304-1 2016-10 Health software -- Part 1: General requirements for product safety Ed 1
IEC 62366-1 Ed. 1.0: 2015 Corr 2016 - Medical devices - Part 1: Application of usability engineering to medical devices
IEC/TR 62366-2 Ed. 1.0: 2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
ISO/IEC TR 29119-6:2021 Ed. 1.0: 2021-07 Software and systems engineering — Software testing — Part 6: Guidelines for the use of ISO/IEC/IEEE 29119 (all parts) in agile projects

IMDRF

Reference Standard Edition
imdrf-tech-170921-samd-n41-clinical-evaluation_1 21.09.2017 imdrf-tech-170921-samd-n41-clinical-evaluation_1
imdrf-tech-181031-grrp-essential-principles-n47 31.10.2018 Essential Principles of Safety and Performance of MD and IDV MD
imdrf-tech-190321-labelling 21.03.2019 imdrf-tech-190321-labelling
imdrf-tech-190321-udi-sag 21.03.2019 imdrf-tech-190321-udi-sag
imdrf-tech-191010-ClinicalEvaluation 10.10.2019 imdrf-tech-191010-ClinicalEvaluation
imdrf-tech-191010-ClinicalEvidence 10.10.2019 imdrf-tech-191010-ClinicalEvidence
imdrf-tech-200318-Cybersecurity 18.03.20 imdrf-tech-200318-Cybersecurity
IMDRF/SaMD WG/N23 FINAL: 2015 42279 Software as a Medical Device (SaMD): Application of Quality Management System
imdrf-tech-210325-PMCF_Studies 25.03.21 imdrf-tech-210325-PMCF_Studies
IMDRF/SaMD WG/N10FINAL:2013 41617 Software as a Medical Device (SaMD): Key Definitions
IMDRF/SaMD WG/N12FINAL:2014 41900 "Software as a Medical Device": Possible Framework for Risk Categorization and Corresponding Considerations

Australia

Reference Version Edition
Therapeutic Goods (Medical Devices) Regulations 2021 20.Dec.2022 Full Quality Assurance System

Brasil

Reference Version Edition
Federal Law n. 6360/76
RDC ANVISA n. 16/2013 - Good Manufacturing Practices
RDC ANVISA n. 23/2012
RDC ANVISA n. 67/2009 - Vigilance
RDC ANVISA n. 56/2001 - Essential Requirements for Safety and Effectiveness		 September 23, 1976 Law nº 6.360, of September 23, 1976

Canada

Reference Version Title
CMDR SOR/98-282 01.03.2024 Medical Device Regulations
Amendment SOR/2020-262 04.12.2020 Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Post-market Surveillance of Medical Devices):

Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Post-market Surveillance of Medical Devices):

EU

EU Languages Publication: https://health.ec.europa.eu/publications/overview-language-requirements-manufacturers-medical-devices_en

Regulations

Reference Version Title
EU 2017/745 on medical devices: final text (5-May 17) May-2017 effective 23-May 2020 medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices, Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and Repealing Council Directives 90/385/EEC and 93/42/EEC - Mar 2019 Corrigendum to MDR 2017/745
DIRECTIVE 2009/3/EC (Council Directive 80/181/EEC of 20 December 1979) 11 March 2009 Metric Directive (relating to units of measurement) (amending Council Directive 80/181/EEC on the approximation of the laws of the Member States relating to units of measurement)
Electronic IFU 207/2012 Mar 2012 on electronic instructions for use of medical devices

MDCG

Reference Version Title
MDCG_2021-1 2021-05 01_MDCG_2021-1_guidance-administrative-practices_en
MDCG_2020-7 2020-04 03_MDCG_2020-7 Guidance on PMCF Plan Template
MDCG_2021-3 2021-03 03_MDCG_2021-3_Custom-made_en
MDCG_2019_4 2019-04 04_MDCG_2019_4_devices_registration_eudamed_en
MDCG_2020-8 2020-04 04_MDCG_2020-8 Guidance on PMCF Evaluation Report Template
MDCG_2019_5 2019-04 05_MDCG_2019_5_legacy_devices_registration_eudamed_en
MDCG_2020-1 2020-03 01_MDCG_2020-1_Guidance on Clinical Evaluation
MDCG_2020-5 2020-04 05_MDCG_2020-5 Guidance on Clinical Evaluation - Equivalence
MDCG_2021_5 2021-04 05_MDCG_2021_5_standardisation_en
MDCG_2020-6 2020-04 06_MDCG_2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices
MDCG_2021-12 2021-05 12_MDCG_2021-12_EU_Nomenclature_en
MDCG_2021-13 2021-07 13_MDCG_2021-13_q-a-actor_registr_eudamed_en
MDCG_2020-15 2020-08 15_MDCG_2020-15-position-paper-actor-registration-module_en
MDCG 2019-11 43757 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
MDCG 2021-24 2021-10 Guidance on classification of medical devices
MDCG_2019-16 2019-12 Guidance on cybersecurity for medical devices
MDCG 2020-10/1 Rev.1 2022-10 Guidance on safety reporting in clinical investigations
Appendix: Clinical investigation summary safety report form
MDCG 2022-21 2022-12 GUIDANCE ON PERIODIC SAFETY UPDATE REPORT (PSUR) ACCORDING TO REGULATION (EU) 2017/745 (MDR)
MDCG 2021-08 2021-05 Clinical investigation application/notification documents
MDCG 2022-7 2022-05 Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
MDCG 2022-16 2022-10 Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

Japan

Reference Version Edition
PMD Act (J-QMS ordinance) MHLW MO169 2021 Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents Revision of the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics

Switzerland

Reference Version Edition
TPA 2021 Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act,TPA)
MEdDo SR 812.213 2021 Medical Device Ordinance (MEdDo)
IvDO SR 812.219 Ordinance on In Vitro Diagnostic Medical Devices
FADP 1992 Federal Act on Data Protection (FADP)
Medical Devices Act 26 May 2022
Clinical Trials Ordinance, ClinO 2021 Ordinance on Clinical Trials with the exception of Clinical Trials of Medical Devices
Information Sheet Medical Device Software 3.0 10.04.2024 BW630_30_007

Taiwan

Reference Version Edition
Medical Devices Act TW
Medical Device Quality Management System Regulations 2021 Medical Device Quality Management System Regulations

US

CFR

Reference Version Edition
21 CFR Part 801 22.Oct.2022 Labeling
21 CFF Part 820 2022-03-29 QMS regulation US
45 CFR PART 160
45 CFR PART 164
45 CFR PART 162 January 25, 2013 Standards for Privacy of Individually Identifiable Health Information (HIPAA Privacy Rule)
SMDA 35600 Safe Medical Devices Act of 1990 FDA Modernization Act of 1997

FD&C Act

Reference Version Edition
Section 524B Draft 03.2024 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act, Draft Guidance for Industry and Food and Drug Administration Staff

Guidances

Reference Version Edition
Guidance_Postmarket Management of Cybersecurity_Dec2016 42732 Guidance_Postmarket Management of Cybersecurity_Dec2016
Software Validation 37267 General Principles of Software Validation; Final Guidance for Industry and FDA Staff
SW_Guidance 43036 SW_Guidance

MEDDEV

Reference Version Title
G MEDDEV_2_7_1_rev4 2016-01

Mexico