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        • R-001-001 Control of documents 2023_003
        • R-001-002 2020_001 Manufacturer declaration of conformity
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        • R-001-005 List of external documents_2023_001
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      • R-001-001 Control of documents
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      • R-001-005 List of external documents
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  • GP-001 Documents and records control
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  • R-001-005 List of external documents_2023_003

R-001-005 List of external documents_2023_003

  • Governed by GP-001 Document and Registry Control
  • Comes from template T-001-005

Template version control​

Reason for reviewDateVersion id
First version202301271
Record release section included202306142
Written byReviewed by

E-Signature (Appfire integration):

Signature logo

María Diez

71E385973E06BC166D9B19B36FFF8829

Signer name: María Diez

Signing time: Tue, 13 Jun 2023 11:12:21 GMT

Reason: Creation of document

E-Signature (Appfire integration):

Signature logo

Alfonso Medela

1E062440C2BCDEF7F7E6E4D45078751D

Signer name: Alfonso Medela

Signing time: Wed, 14 Jun 2023 11:11:29 GMT

Reason: Reviewed

Quality manager (QM)Technical manager (PRRC)

External documents archive​

External documents are compiled at the GoogleDrive workspace: https://drive.google.com/drive/folders/1XtUaSvT0yzhfuIUyFhXUiqZxHpNVkz3d They are organized in folders regarding their main related issue. The following tables list all the documents compiled, one table per folder.

Spanish Regulations​

CodeNameSourceVersionDateImpact
01_01Instrucción PS1/2023 sobre el procedimiento de licencia previa de funcionamiento de instalaciones de productos sanitariosAEMPSPS 1/202320230329No
01_02CERTPS-ManualEmpresa: Certificado de libre ventaAEMPS1.820230428No
01_03R_DEX_18_Guía para la elaboración de la documentación técnica: Marcado CE MDRCNCPS202220220627Yes. TF being prepared
01_04Real Decreto 192/2023 por el que se regulan los productos sanitarios_7416BOE20230321No
01_05Real Decreto 1907/1996 sobre publicidad y promoción comercial de productos, actividades o servicios con pretendida finalidad sanitariaBOE19960806No
01_06Real Decreto 1591/2009 por el que se regulan los productos sanitariosBOE20091106No
01_07Real 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 EstudioClínicosBOE20151224No
01_082021 Código de buenas prácticas de la industria farmacéuticaSistema de autorregulación Farmaindustria2021No

CFR_FDA​

CodeNameSourceVersionDateImpact
02_01Guidance Computer Software Assurance for production and Quality System SoftwareFDA202220220913No
02_02Guidance for Industry. Part 11, Electronic Records; Electronic SignaturesFDA20230801No
02_0321 CFR Part 11 Electronic records; electronic signaturesFDA20230602No
02_04General principles of software validation; final guidance for industry and FDA staffFDA20020111No
02_05The Q submission programFDA20230602No

Clinical studies​

CodeNameSourceVersionDateImpact?
03_01Guideline for good clinical practice E6 (R2) Step 5EMA/ICHE6 (R2)20170614

EU Medical devices​

CodeNameSourceVersionDateImpact
04_01Directive 93/42/EEC concerning medical devicesEuropean CommissionM520071011No
04_02Regulation 2017/745 on medical devicesEuropean CommissionM120200424Yes. Adaptation proccess in progress
04_03Regulation 2017/2185 related to codes and medical devicesEuropean Commission20171124No
04_04Regulation 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisionsEuropean Commission20230320Yes. We can sell our product under the MDD until December 2028.
04_05Commision regulation 207/2012 on electronic instructions for use of medical devicesEuropean Commission20120310Yes. We shall adapt our IFU to the requirements
04_06Commision regulation 2021/2226 on electronic instructions for use of medical devicesEuropean Commission20211214Yes. We shall adapt our IFU to the requirements

Guides​

MDCG guidelines can be downloaded on their last version from the European Commission webpage (https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en).

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

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

CodeNameSourceVersionDateImpact?
04_G01Manual on borderline and classification in the community regulatory framework for medical devices1.2220190501No
04_G02Manual on borderline and classification for MD under MDR and IVDR220231201No
04_G03Additional guidance regarding the vigilance system as outlined in MEDDEV 2.12-1 rev.8European Commission820181104No
04_G04MDCG 2020-5 Clinical evaluation - EquivanceMDCG020200401No
04_G05MDCG 2020-7 PMCF plan templateMDCG020200401No
04_G06MDCG-2020-8 PMCF evaluation report templateMDCG020200401No
04_G07MDCG-2020-1 Guidance con clinical evaluation of MD softwareMDCG020200301No
04_G08MDCG 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 AIMDDMDCG120221201No
04_G09MDCG 2022-2021 Guidance on PSUR according to regulation (EU) 2017/745 (MDR)MDCG020221201No
04_G10MDCG 2023-3 Questions and answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devicesMDCG020230201No
04_G11Meddev 2.1/6 Guidelines on the qualification and classification of stand alone software used in thealthcare within the regulatory framework of medical devicesEuropean Commission020160701No
04_G12Meddev 2.7/1 Guidelines on medical devicesEuropean Commission420160601No
04_G132023/C 163/06 Content and structure of the summary of the clinical investigation reportEuropean Commission20230508Yes. We have to include this requirement within our GP-015 procedure
04_G14MDCG 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 AIMDDMDCG120230501No

GP-004 Vigilance System​

CodeNameSourceVersionDateImpact
05_01Meddev Manufacturer's trend report formEuropean Commission1.1320181104No
05_02Meddev Manufacturer's periodic summary report formEuropean Commission1.1320181104No
05_03Meddev National competent authority report formatEuropean Commission1.1320181104No
05_04Meddev report form for manufacturer's to the national competent authorityEuropean Commission1.1320181104No
05_05Manufacturer Incident report (MIR) for seious incidents and incidentsEuropean Commission7.2.1No
05_06Meddev template for a field safety noticeEuropean Commission820181104No
05_07Meddev report form for field safety corrective actionEuropean Commission1.1320181104No

Machine learning​

CodeNameSourceVersionDateImpact
06_01Good machine learning practice for MD development: guiding principlesFDA, Health Canada / Medicines & Healthcare products regulatory agency20211001No
06_02Proposed regulatory framework for modifications to AI/ML based SaMDFDANo

Quality Regulations​

CodeNameSourceVersionDateImpact
ISO13485ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposesISOE20160301No
ISO62304ISO 62304 :2006 Software de dispositivos médicos. Procesos del ciclo de vida del softwareAENOR20070301No
ISO9001Sistemas de gestión de la calidad - Fundamentos y vocabularioISO2015No
ISO14155ISO 14155 Investigación clínica de productos sanitarios para humanos. Buenas prácticas clínicasUNE2020No
ISO14971ISO14791 Medical devices - Application of risk management to medical devicesISO20191201No
ISO15223-1ISO15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be suppliedISO20170301No
ISO24791ISO24791 Medical devices - Guidance on the application of ISO14971ISO2.9d20180717No
ISO62366-1ISO62366-1 Medical devices - Part 1: Application of usability engineering to medical devicesAENOR20200801No
ISO9001ISO9001 Sistemas de gestión de la calidad. RequisitosAENOR20150901No
ISO27001ISO27001 Tecnología de la información. Técnicas de seguridad. Sistemas de gestión de la seguridad de la información. RequisitosUNE20170201No
ISO27002ISO27002 Tecnología de la información. Técnicas de seguridad. Código de prácticas para los controles de seguridad de la informaciónAENOR/MINCOTUR20170501No

Mexico Regulations​

CodeNameSourceVersionDateImpact
08_01Ley general de saludCámara de diputados del H. Congreso de la Unión20230324No
08_02Listado de insumos para la salud de bajo riesgoDOF20111231No
08_03Listado de insumos para la salud de bajo riesgoDOF20141222No
08_04Reglamento de insumos para la saludGobierno México20210531No

Pharmacy​

CodeNameSourceVersionDateImpact
09_01Directive 2005/36/EC on the recognition of professional qualifications and Regulation (EU) No 1024/2012 on administrative cooperation through the Internal Market Information SystemEuropean Commission20131228No
09_02Ley 16/1997 de Regulación de Servicios de las Oficinas de FarmaciaBOE19970425No
09_03Real Decreto 1/2015: Ley de garantías y uso racional de los medicamentos y productos sanitariosBOE20150725No
09_04Consenso sobre Atención FarmacéuticaMinisterio de Sanidad, Consumo y Bienestar SocialNIPO: 351-02-018-0No

Other​

CodeNameSourceVersionDateImpact
10_01Real Decreto-ley de medidas urgentes de protección social y de lucha contra la precariedad laboral en la jornada de trabajoBOE20190312No
10_02Directive 2022/2555 on measures for a high common level of cybersecurity across the UnionEuropean Commission20221214No

Record release​

Record released by

E-Signature (Appfire integration):

Signature logo

María Diez

CC8B16F57C3A17B63D12D33EA50FC582

Signer name: María Diez

Signing time: Wed, 14 Jun 2023 12:19:45 GMT

Reason: Record release

JD-004 Quality Manager & PRRC
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  • Record release
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)