R-001-005 List of external documents_2023_004

External documents archive

External documents are compiled at the Google Drive workspace. They are organized in folders regarding their main related issue. The following tables list all the documents contained, one table per folder.

Spanish Regulations

Code	Name	Source	Version	Date	Impact
01_01	Instrucción PS1/2023 sobre el procedimiento de licencia previa de funcionamiento de instalaciones de productos sanitarios	AEMPS	PS 1/2023	20230329	No
01_02	CERTPS-ManualEmpresa: Certificado de libre venta	AEMPS	1.8	20230428	No
01_03	R_DEX_18_Guía para la elaboración de la documentación técnica: Marcado CE MDR	CNCPS	2022	20220627	Yes. TF being prepared
01_04	Real Decreto 192/2023 por el que se regulan los productos sanitarios_7416	BOE		20230321	No
01_05	Real Decreto 1907/1996 sobre publicidad y promoción comercial de productos, actividades o servicios con pretendida finalidad sanitaria	BOE		19960806	No
01_06	Real Decreto 1591/2009 por el que se regulan los productos sanitarios	BOE		20091106	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		20151224	No
01_08	2021 Código de buenas prácticas de la industria farmacéutica	Sistema de autorregulación Farmaindustria		2021	No

CFR_FDA

Code	Name	Source	Version	Date	Impact
02_01	Guidance Computer Software Assurance for production and Quality System Software	FDA	2022	20220913	No
02_02	Guidance for Industry. Part 11, Electronic Records; Electronic Signatures	FDA		20230801	No
02_03	21 CFR Part 11 Electronic records; electronic signatures	FDA		20230602	No
02_04	General principles of software validation; final guidance for industry and FDA staff	FDA		20020111	No
02_05	The Q submission program	FDA		20230602	No
02_06	21 CFR part 820 Quality System Regulation	FDA		20230927	Yes. To adapt the QMS to this regulation. Already ongoing with our external consultant
02_07	Postmarket management of cybersecurity in medical devices	FDA		20161228	No
02_08	Marketing submission recommendations for a predetermined change control plan for AI/ML-enabled device software functions	FDA		20230403	Yes, to be reviewed for the FDA application. Already ongoing with our external consultant
02_09	Cybersecurity in medical devices: Quality system considerations and content of premarket submissions	FDA		20230917	Yes, to be considered for the FDA application. Already ongoing with our external consultant

Clinical studies

Code	Name	Source	Version	Date	Impact?
03_01	Guideline for good clinical practice E6 (R2) Step 5	EMA/ICH	E6 (R2)	20170614

EU Medical devices

Code	Name	Source	Version	Date	Impact
04_01	Directive 93/42/EEC concerning medical devices	European Commission	M5	20071011	No
04_02	Regulation 2017/745 on medical devices	European Commission	M1	20200424	Yes. Adaptation proccess in progress
04_03	Regulation 2017/2185 related to codes and medical devices	European Commission		20171124	No
04_04	Regulation 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions	European Commission		20230320	Yes. We can sell our product under the MDD until December 2028.
04_05	Commision regulation 207/2012 on electronic instructions for use of medical devices	European Commission		20120310	Yes. We shall adapt our IFU to the requirements
04_06	Commision regulation 2021/2226 on electronic instructions for use of medical devices	European Commission		20211214	Yes. We shall adapt our IFU to 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 compile some of these 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	20190501	No
04_G02	Manual on borderline and classification for MD under MDR and IVDR		2	20231201	No
04_G03	Additional guidance regarding the vigilance system as outlined in MEDDEV 2.12-1 rev.8	European Commission	8	20181104	No
04_G04	MDCG 2020-5 Clinical evaluation - Equivance	MDCG	0	20200401	No
04_G05	MDCG 2020-7 PMCF plan template	MDCG	0	20200401	No
04_G06	MDCG-2020-8 PMCF evaluation report template	MDCG	0	20200401	No
04_G07	MDCG-2020-1 Guidance con clinical evaluation of MD software	MDCG	0	20200301	No
04_G08	MDCG 2022-4 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regar to devices covered by certificates according to the MDD or the AIMDD	MDCG	1	20221201	No
04_G09	MDCG 2022-2021 Guidance on PSUR according to regulation (EU) 2017/745 (MDR)	MDCG	0	20221201	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	0	20230201	No
04_G11	Meddev 2.1/6 Guidelines on the qualification and classification of stand alone software used in thealthcare within the regulatory framework of medical devices	European Commission	0	20160701	No
04_G12	Meddev 2.7/1 Guidelines on medical devices	European Commission	4	20160601	No
04_G13	2023/C 163/06 Content and structure of the summary of the clinical investigation report	European Commission		20230508	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 with regard to devices covered by certificates according to MDD or AIMDD	MDCG	1	20230501	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	20230901	No
04_G16	Principles and practices for medical device cybersecurity	IMDRF		20200318	No
04_G17	Machine Learning-enabled Medical Devices: Key Terms and Definitions	IMDRF		20220506	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	20181104	No
05_02	Meddev Manufacturer's periodic summary report form	European Commission	1.13	20181104	No
05_03	Meddev National competent authority report format	European Commission	1.13	20181104	No
05_04	Meddev report form for manufacturer's to the national competent authority	European Commission	1.13	20181104	No
05_05	Manufacturer Incident report (MIR) for seious incidents and incidents	European Commission	7.2.1		No
05_06	Meddev template for a field safety notice	European Commission	8	20181104	No
05_07	Meddev report form for field safety corrective action	European Commission	1.13	20181104	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		20211001	No
06_02	Proposed regulatory framework for modifications to AI/ML based SaMD	FDA			No

Quality Regulations

Code	Name	Source	Version	Date	Impact
ISO13485	ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes	ISO	E	20160301	No
ISO62304	ISO 62304 :2006 Software de dispositivos médicos. Procesos del ciclo de vida del software	AENOR		20070301	No
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 Medical devices - Application of risk management to medical devices	ISO		20191201	No
ISO15223-1	ISO15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied	ISO		20170301	No
ISO24791	ISO24791 Medical devices - Guidance on the application of ISO14971	ISO	2.9d	20180717	No
ISO62366-1	ISO62366-1 Medical devices - Part 1: Application of usability engineering to medical devices	AENOR		20200801	No
ISO9001	ISO9001 Sistemas de gestión de la calidad. Requisitos	AENOR		20150901	No
ISO27001	ISO27001 Tecnología de la información. Técnicas de seguridad. Sistemas de gestión de la seguridad de la información. Requisitos	UNE		20170201	No
ISO27002	ISO27002 Tecnología de la información. Técnicas de seguridad. Código de prácticas para los controles de seguridad de la información	AENOR/MINCOTUR		20170501	No

Mexican regulations

Code	Name	Source	Version	Date	Impact
08_01	Ley general de salud	Cámara de diputados del H. Congreso de la Unión		20230324	No
08_02	Listado de insumos para la salud de bajo riesgo	DOF		20111231	No
08_03	Listado de insumos para la salud de bajo riesgo	DOF		20141222	No
08_04	Reglamento de insumos para la salud	Gobierno México		20210531	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		20131228	No
09_02	Ley 16/1997 de Regulación de Servicios de las Oficinas de Farmacia	BOE		19970425	No
09_03	Real Decreto 1/2015: Ley de garantías y uso racional de los medicamentos y productos sanitarios	BOE		20150725	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		20190312	No
10_02	Directive 2022/2555 on measures for a high common level of cybersecurity across the Union	European Commission		20221214	No

Record signature meaning

• Author: JD-004 María Diez
• Review: JD-003 Taig MacCarthy
• Approval: JD-001 Andy Aguilar