# List of Regulatory Requirements

Author: Sören Hornof
Published: 2023-01-24
Updated: 2024-04-26
Source: https://openregulatory.com/document_templates/list-of-regulatory-requirements

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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:
ISO 13485:2016 Sections 5.6.2 and 7.3.3
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 (https://eur-lex.europa.eu/eli/reg/2016/679/oj)	
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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 (https://www.gesetze-im-internet.de/mpdg/)	
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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 (https://www.iso.org/standard/59752.html)	
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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 (https://health.ec.europa.eu/system/files/2021-04/md_mdcg_2018-1_guidance_udi-di_en_0.pdf)	
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