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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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  • GP-001 Documents and records control
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R-001-005 List of external documents_2023_002

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

Version control​

Reason for reviewDateVersion id
First version202301271
Written byReviewed by

E-Signature (Appfire integration):

Signature logo

María Diez

E6E2ADC8FAFCBA3E606AF8CB996DC724

Signer name: María Diez

Signing time: Tue, 16 May 2023 14:48:23 GMT

Reason: Creation of document

E-Signature (Appfire integration):

Signature logo

Alfonso Medela

C4A459D524CE5CA0E93CD6A75E05E8D9

Signer name: Alfonso Medela

Signing time: Wed, 17 May 2023 14:47:31 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 PS1/2022 sobre el procedimiento de licencia previa de funcionamiento de instalaciones de productos sanitariosAEMPSPS 1/202220220401No
01_03R_DEX_18_Guía para la elaboración de la documentación técnica: Marcado CE MDRCNCPS202220220627Yes. TF being prepared
01_02CERTPS-ManualEmpresa: Certificado de libre ventaAEMPS1.820230428No
01_04Real Decreto 192/2023 por el que se regulan los productos sanitarios_7416BOE20230321No

CFR_FDA​

CodeNameSourceVersionDateImpactFolder
02_01Guidance Computer Software Assurance for production and Quality System SoftwareFDA202220220913NoCFR_FDA
02_02Guidance for Industry. Part 11, Electronic Records; Electronic SignaturesFDA20230801CFR_FDA

Clinical studies​

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

EU Medical devices​

CodeNameSourceVersionDateImpactFolder
04_01Directive 93/42/EEC concerning medical devicesEuropean CommissionM520071011NoCFR_FDA
04_02Regulation 2017/745 on medical devicesEuropean CommissionM120200424Yes. Adaptation proccess in progressCFR_FDA
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

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:

| 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 | Folder | | 04_G02 | Manual on borderline and classification for MD under MDR and IVDR | | 2 | 20231201 | No | CFR_FDA | | 04_G03 | Additional guidance regarding the vigilance system as outlined in MEDDEV 2.12-1 rev.8 | European Commission | 8 | 20181104 | No | CFR_FDA | | 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 | |

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​

CodeNameSourceVersionDateImpactFolder
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 Commission20131228NoPharmacy
09_02Ley 16/1997 de Regulación de Servicios de las Oficinas de FarmaciaBOE19970425NoPharmacy
09_03Real Decreto 1/2015: Ley de garantías y uso racional de los medicamentos y productos sanitariosBOE20150725NoPharmacy
09_04Consenso sobre Atención FarmacéuticaMinisterio de Sanidad, Consumo y Bienestar SocialNIPO: 351-02-018-0NoPharmacy

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
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  • Machine learning
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  • Mexico Regulations
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