Templates ISO 13485 Templates

Updated January 27, 2023

Template: List of Regulatory Requirements

Sören Hornof

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List of Regulatory Requirements

1. General Information

This document lists the applicable standards, norms and regulations for the medical device.

It is regularly updated pursuant to the SOP Update of Regulations and implications of changed requirements are assessed.

Regulatory references:

Use this template to give yourself an idea of the necessary structure and contents. Ideally, this documentation is maintained best in a spreadsheet / excel file format.

2. Regulations

Regulation Applicability Description Jurisdiction Notes Review Cycle Last Review Links
(GDPR) General Data Protection Regulation Applies Regulates the protection of natural persons with regard to the processing of personal data and on the free movement of such data. EU   Annual   EU law
(…)              

3. National Laws

Regulation Applicability Description Jurisdiction Notes Review Cycle Last Review Links
(MPDG) German Medical Devices Law Applies Replaces old MPG D   Annual - German law
(…)              

4. Standards and Norms

Regulation Applicability Description Jurisdiction Notes Review Cycle Last Review Links
EN ISO 13485:2016 + AC:2018 + A11:2021 Applies QM Systems International   Annual - ISO
(…)              

5. Guidances

Regulation Applicability Description Jurisdiction Notes Review Cycle Last Review Links
MDCG 2018-1 rev4 04-2021 Applies Guidance on basic UDI-DI and changes to UDI-DI EU   Annual - EU text
(…)              

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