1. General Information
This document outlines the relevant standards, norms, and regulations applicable to the medical device.
It is periodically updated according to the SOP for Regulation Updates, ensuring that changes in requirements are evaluated.
Regulatory references:
- ISO 13485:2016 Sections 5.6.2 and 7.3.3
This template serves as a guide for structuring and populating the information. It is recommended to maintain this documentation in a spreadsheet or Excel format for better organization.
2. Regulations
| Regulation | Applicability | Description | Jurisdiction | Notes | Review Frequency | Last Review | Links |
|---|---|---|---|---|---|---|---|
| (GDPR) General Data Protection Regulation | Applies | Governs the protection of personal data and the free movement of such data. | EU | Annual | EU law | ||
| (…) |
3. National Laws
| Regulation | Applicability | Description | Jurisdiction | Notes | Review Frequency | Last Review | Links |
|---|---|---|---|---|---|---|---|
| (MPDG) German Medical Devices Law | Applies | Supersedes the old MPG | Germany | Annual | – | German law | |
| (…) |
4. Standards and Norms
| Regulation | Applicability | Description | Jurisdiction | Notes | Review Frequency | Last Review | Links |
|---|---|---|---|---|---|---|---|
| EN ISO 13485:2016 + AC:2018 + A11:2021 | Applies | Quality Management Systems | International | Annual | – | ISO | |
| (…) |
5. Guidances
| Regulation | Applicability | Description | Jurisdiction | Notes | Review Frequency | Last Review | Links |
|---|---|---|---|---|---|---|---|
| MDCG 2018-1 rev4 04-2021 | Applies | Guidance on basic UDI-DI and UDI-DI changes | EU | Annual | – | EU text | |
| (…) |