R-001-005 List of external documents_2023_001
- Governed by
GP-001 Document and Registry Control
- Comes from template T-001-005
Version control
Reason for review | Date | Version id |
---|---|---|
First version | 20230127 | 1 |
Written by | Reviewed by |
---|---|
E-Signature (Appfire integration): María Diez BC8BB89A5A502F2AD8C639970D984645 Signer name: María Diez Signing time: Thu, 26 Jan 2023 13:20:43 GMT Reason: Creation of document | E-Signature (Appfire integration): Alfonso Medela 16434E53E6324722E53B2288E08237FE Signer name: Alfonso Medela Signing time: Fri, 27 Jan 2023 13:19:51 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.
AEMPS & CNCPS
Name | Source | Version | Date | Impact? |
---|---|---|---|---|
Instrucción PS1/2022 sobre el procedimiento de licencia previa de funcionamiento de instalaciones de productos sanitarios | AEMPS | PS 1/2022 | 04/01/2022 | No |
R_DEX_18_Guía para la elaboración de la documentación técnica: Marcado CE MDR | CNCPS | 2022 | 06/27/2022 | Yes. TF being prepared |
CERTPS-ManualEmpresa: Certificado de libre venta | AEMPS | 2.1.0 | Yes. Certificate application submited |
CFR_FDA
Name | Source | Version | Date | Impact? |
---|---|---|---|---|
Guidance Computer Software Assurance for production and Quality System Software | FDA | 2022 | 09/13/2022 | No |
Guidance for Industry. Part 11, Electronic Records; Electronic Signatures | FDA | 08/2023 |
Clinical studies
Name | Source | Version | Date | Impact? |
---|---|---|---|---|
Guideline for good clinical practice E6 (R2) Step 5 | EMA/ICH | E6 (R2) | 06/14/2017 |
EU Medical devices
Name | Source | Version | Date | Impact? |
---|---|---|---|---|
Directive 93/42/EEC concerning medical devices | European Commission | M5 | 10/11/2007 | No |
Regulation 2017/745 on medical devices | European Commission | M1 | 04/24/2020 | Yes. Adaptation proccess in progress |
Regulation 2017/2185 related to codes and medical devices | European Commission | 11/24/2017 | No | |
Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions | European Commission | 2023/0005 | 01/06/2023 | No |
Manufacturer incident report (MIR) | European Commission | 7.2.1 | No |
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:
Name | Source | Version | Date | Impact? |
---|---|---|---|---|
Manual on borderline and classification in the community regulatory framework for medical devices | 1.22 | 05/2019 | No | |
Additional guidance regarding the vigilance system as outlined in MEDDEV 2.12-1 rev.8 | European Commission | 8 | 07/10/2019 | No |
MDCG 2020-5 Clinical evaluation - Equivance | MDCG | 0 | 04/2020 | No |
MDCG 2020-7 PMCF plan template | MDCG | 0 | 04/2020 | No |
MDCG-2020-8 PMCF evaluation report template | MDCG | 0 | 04/2020 | No |
MDCG-2020-1 Guidance con clinical evaluation of MD software | MDCG | 0 | 03/2020 | No |
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 | 12/2022 | No |
MDCG 2022-2021 Guidance on PSUR according to regulation (EU) 2017/745 (MDR) | MDCG | 0 | 12/2022 | No |
MDCG 2023-3 Questions and answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices | MDCG | 0 | 02/2023 | No |
Meddev 2.12-1 Guidelines on a medical devices vigilance system | European Commission | 8 | 01/2013 | No |
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 | 07/2016 | No |
Meddev 2.7/1 Guidelines on medical devices | European Commission | 4 | 06/2016 | No |
Quality Regulations
Name | Source | Version | Date | Impact? |
---|---|---|---|---|
ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes | ISO | E | 03/01/2016 | |
ISO 62304 :2006 Software de dispositivos médicos. Procesos del ciclo de vida del software | AENOR | 03/2007 |