R-001-005 List of external documents

External documents archive

External documents are compiled at the QMS and reviewed every year and when needed. They are organized in folders according to topic or country. The following tables list all the external documents stored in the QMS, one table per folder.

Spanish Regulations

Code	Name	Source	Version	Date	Impact
01_01	Instrucción PS1/2022 sobre el procedimiento de licencia previa de funcionamiento de instalaciones de productos sanitarios	AEMPS	PS 1/2022	2022-04-01	No
01_02	CERTPS-ManualEmpresa: Certificado de libre venta	AEMPS	2.1	2023-11-21	No
01_03	R_DEX_18_Guía para la elaboración de la documentación técnica: Marcado CE MDR	CNCPS	3	2024-12-01	Yes, to review the current revision of the guidance to ensure compliance
01_04	Real Decreto 192/2023 por el que se regulan los productos sanitarios_7416	BOE		2023-03-21	No
01_05	Real Decreto 1907/1996 sobre publicidad y promoción comercial de productos, actividades o servicios con pretendida finalidad sanitaria	BOE		1996-08-06	No
01_06	Real Decreto 1591/2009 por el que se regulan los productos sanitarios	BOE		2009-11-06	No
01_07	Real Decreto 1090/2015 por el que se regulan los ensayos clínicos con medicamentos, los Comités de Ética de la Investigación con medicamentos y el Registro Español de EstudioClínicos	BOE		2015-12-24	No
01_08	2021 Código de buenas prácticas de la industria farmacéutica	Sistema de autorregulación Farmaindustria		2023	No

CFR_FDA

Code	Name	Source	Version	Date	Impact
02_01	Guidance Computer Software Assurance for production and Quality System Software	FDA	2022	2022-09-13	No
02_02	Guidance for Industry. Part 11, Electronic Records; Electronic Signatures	FDA		2023-08-01
02_03	21 CFR Part 11 Electronic records; electronic signatures	FDA		2023-06-02	No
02_04	General principles of software validation; final guidance for industry and FDA staff	FDA		2002-01-11	No
02_05	The Q submission program	FDA		2023-06-02	No
02_06	21 CFR part 820 Quality System Regulation	FDA		2023-09-27	Yes. To adapt the QMS to this regulation. Already ongoing with our external consultant
02_07	Postmarket management of cybersecurity in medical devices	FDA		2016-12-28	Yes. To take into consideration in the post-market phase once we obtain FDA approval
02_08	Marketing submission recommendations for a predetermined change control plan for AI/ML-enabled device software functions	FDA		2024-12-04	Yes, to be reviewed for the FDA application. Procedure and template already created in the QMS
02_09	Cybersecurity in medical devices: Quality system considerations and content of premarket submissions	FDA		2023-09-27	Yes, to be considered for the FDA application. Already ongoing with our external consultant
02_10	Applying Human Factors and Usability Engineering to Medical Devices	FDA		2016-02-03	Yes, to be considered for the FDA application. Already ongoing with our external consultant
02_11	Content of Human Factors Information in Medical Device Marketing Submissions	FDA		2022-12-09	Yes, to be considered for the FDA application. Already ongoing with our external consultant
02_12	Content of Premarket Submissions for Device Software Functions	FDA		2023-06-14	Yes, to be considered for the FDA application. Already ongoing with our external consultant
02_13	Medical Device User Fee Small Business Qualification and Certification	FDA		2018-08-01	Yes, already considered for registering Legit.Health as a small business in the USA

Clinical studies

Code	Name	Source	Version	Date	Impact?
03_01	Guideline for good clinical practice E6 (R2) Step 5	EMA/ICH	E6 (R2)	2017-06-14	No

EU Medical devices

Code	Name	Source	Version	Date	Impact
04_01	Directive 93/42/EEC concerning medical devices	European Commission	M5	2007-10-11	No
04_02	Regulation 2017/745 on medical devices	European Commission	M1	2020-04-24	Yes, QMS and technical documentation updated accordingly
04_03	Regulation 2017/2185 related to codes and medical devices	European Commission		2017-11-24	No
04_04	Regulation 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions	European Commission		2023-03-20	Yes. We can sell our product under the MDD until December 2028.
04_05	Commission regulation 207/2012 on electronic instructions for use of medical devices	European Commission		2012-03-10	It has been replaced by Commission regulation 2021/2226. Moved to deprecated in the QMS
04_06	Commission regulation 2021/2226 on electronic instructions for use of medical devices	European Commission		2021-12-14	Yes, IFU and other documents of the QMS and technical documentation have been reviewed to comply with the requirements

Guides

• MDCG guidelines can be downloaded on their last version from the European Commission website.
• MedDev guidelines can be consulted and downloaded on their last version from the European Commission website.

In the following table we have compiled some of the guidelines that we have consulted during the medical device documentation preparation:

Code	Name	Source	Version	Date	Impact
04_G01	Manual on borderline and classification in the community regulatory framework for medical devices		1.22	2019-05-01	No
04_G02	Manual on borderline and classification for MD under MDR and IVDR		2	2023-12-01	No
04_G03	Additional guidance regarding the vigilance system as outlined in MEDDEV 2.12-1 rev.8	European Commission	8	2018-11-04	No
04_G04	MDCG 2020-5 Clinical evaluation - Equivance	MDCG	0	2020-04-01	No
04_G05	MDCG 2020-7 PMCF plan template	MDCG	0	2020-04-01	No
04_G06	MDCG-2020-8 PMCF evaluation report template	MDCG	0	2020-04-01	No
04_G07	MDCG-2020-1 Guidance con clinical evaluation of MD software	MDCG	0	2020-03-01	No
04_G08	MDCG 2022-4 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR about devices covered by certificates according to the MDD or the AIMDD	MDCG	2	2024-05-01	Yes, actions already taken
04_G09	MDCG 2022-2021 Guidance on PSUR according to regulation (EU) 2017/745 MDR	MDCG	0	2022-12-01	No
04_G10	MDCG 2023-3 Questions and answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices	MDCG	2	2025-01-01	Yes, to review the guidance to ensure compliance
04_G11	Meddev 2.1/6 Guidelines on the qualification and classification of stand-alone software used in healthcare within the regulatory framework of medical devices	European Commission	0	2016-07-01	No
04_G12	Meddev 2.7/1 Guidelines on medical devices	European Commission	4	2016-06-01	No
04_G13	2023/C 163/06 Content and structure of the summary of the clinical investigation report	European Commission		2023-05-08	Yes. We have to include this requirement within our GP-015 procedure
04_G14	MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR about devices covered by certificates according to MDD or AIMDD	MDCG	1	2023-05-01	No
04_G15	Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices		3	2023-09-01	No
04_G16	Principles and practices for medical device cybersecurity	IMDRF		2020-03-18	No
04_G17	Machine Learning-enabled Medical Devices: Key Terms and Definitions	IMDRF		2022-05-06	Yes. Definitions have been reviewed to harmonize our documents

GP-004 Vigilance System

Code	Name	Source	Version	Date	Impact
05_01	Meddev Manufacturer's trend report form	European Commission	1.13	2018-11-04	No
05_02	Meddev Manufacturer's periodic summary report form	European Commission	1.13	2018-11-04	No
05_03	Meddev National competent authority report format	European Commission	1.13	2018-11-04	No
05_04	Meddev report form for manufacturers to the national competent authority	European Commission	1.13	2018-11-04	No
05_05	Manufacturer Incident Report (MIR) for serious incidents and incidents	European Commission	7.2.1		No
05_06	Meddev template for a field safety notice	European Commission	8	2018-11-04	No
05_07	Meddev report form for field safety corrective action	European Commission	1.13	2018-11-04	No

Machine learning

Code	Name	Source	Version	Date	Impact
06_01	Good machine learning practice for MD development: guiding principles	FDA, Health Canada / Medicines & Healthcare products regulatory agency		2021-10-01	No
06_02	Proposed regulatory framework for modifications to AI/ML-based SaMD	FDA		2019-04-02	No

Quality Regulations

Code	Name	Source	Version	Date	Impact
ISO13485	ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes	ISO	E	2016-03-01	QMS has been implemented to be compliant with ISO 13485
ISO62304	IEC 62304:2006/A1:2015 Medical device software - Software life cycle processes	AENOR		2015-06-01	Requirements applicable to the risk class of our devices have been implemented in the QMS and the technical documentation
ISO9001	Sistemas de gestión de la calidad - Fundamentos y vocabulario	ISO		2015	No
ISO14155	ISO 14155 Investigación clínica de productos sanitarios para humanos. Buenas prácticas clínicas	UNE		2020	No
ISO14971	ISO14791:2019 Medical devices - Application of risk management to medical devices	ISO		2019-12-01	Requirements for the risk management process have been implemented in the QMS and the technical documentation
ISO15223-1	ISO15223-1:2021 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied	ISO		2021-07-01	Symbols applicable to our medical devices have been implemented in the label and IFU. Action: to buy the current version of the standard, in the QMS we have the previous version
ISO24791	ISO24791 Medical devices - Guidance on the application of ISO14971	ISO	2	2020-06	This is the new version of the guidance, action: to buy the new version and assess the impact
ISO62366-1	ISO62366-1:2015/A1:2020 Medical devices - Part 1: Application of usability engineering to medical devices	AENOR		2020-08-01	Usability requirements implemented in our QMS and technical documentation
ISO9001	ISO9001 Sistemas de gestión de la calidad. Requisitos	AENOR		2015-09-01	No
ISO27001	ISO27001 Tecnología de la información. Técnicas de seguridad. Sistemas de gestión de la seguridad de la información. Requisitos	UNE		2017-02-01	No
ISO27002	ISO27002 Tecnología de la información. Técnicas de seguridad. Código de prácticas para los controles de seguridad de la información	AENOR/MINCOTUR		2017-05-01	No

Mexican regulations

Code	Name	Source	Version	Date	Impact
08_01	Ley general de salud	Cámara de diputados del H. Congreso de la Unión		2024-06-07	Yes, to evaluate impact when working on Mexico registration
08_02	Listado de insumos para la salud de bajo riesgo	DOF		2011-12-31	No
08_03	Listado de insumos para la salud de bajo riesgo	DOF		2014-12-22	No
08_04	Reglamento de insumos para la salud	Gobierno de México		2021-05-31	No

Regulations regarding pharmacists

Code	Name	Source	Version	Date	Impact
09_01	Directive 2005/36/EC on the recognition of professional qualifications and Regulation (EU) No 1024/2012 on administrative cooperation through the Internal Market Information System	European Commission		2013-12-28	No
09_02	Ley 16/1997 de Regulación de Servicios de las Oficinas de Farmacia	BOE		1997-04-25	No
09_03	Real Decreto 1/2015: Ley de garantías y uso racional de los medicamentos y productos sanitarios	BOE		2015-07-25	No
09_04	Consenso sobre Atención Farmacéutica	Ministerio de Sanidad, Consumo y Bienestar Social	NIPO: 351-02-018-0		No

Other regulations

Code	Name	Source	Version	Date	Impact
10_01	Real Decreto-ley de medidas urgentes de protección social y de lucha contra la precariedad laboral en la jornada de trabajo	BOE		2019-03-12	No
10_02	Directive 2022/2555 on measures for a high common level of cybersecurity across the Union	European Commission		2022-12-14	No

UK Medical devices

Code	Name	Source	Version	Date	Impact
11_01	Medical Devices Regulations 2002 No 618 (UK)	MHRA		2024-02-08	We are in the transition period and we can place our device in the UK market until 2028. Applicable requirements will be studied and planned accordingly to meet the due date imposed by the UK MDR

EU AI Act

Code	Name	Source	Version	Date	Impact
12_01	Regulation (EU) 2024/1689 - Artificial Intelligence Act	European Commission		2024-07-12	The AI act entered into force on August 1st, 2024 and there is a transition period. We will plan the required actions according to the established due date

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

• Author: Team members involved
• Reviewer: JD-003, JD-004
• Approver: JD-001