Template: List of Regulatory Requirements

Sören Hornof
January 24, 2023
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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

RegulationApplicabilityDescriptionJurisdictionNotesReview CycleLast ReviewLinks
(GDPR) General Data Protection RegulationAppliesRegulates the protection of natural persons with regard to the processing of personal data and on the free movement of such data.EUAnnualEU law
(…)

3. National Laws

RegulationApplicabilityDescriptionJurisdictionNotesReview CycleLast ReviewLinks
(MPDG) German Medical Devices LawAppliesReplaces old MPGDAnnualGerman law
(…)

4. Standards and Norms

RegulationApplicabilityDescriptionJurisdictionNotesReview CycleLast ReviewLinks
EN ISO 13485:2016 + AC:2018 + A11:2021AppliesQM SystemsInternationalAnnualISO
(…)

5. Guidances

RegulationApplicabilityDescriptionJurisdictionNotesReview CycleLast ReviewLinks
MDCG 2018-1 rev4 04-2021AppliesGuidance on basic UDI-DI and changes to UDI-DIEUAnnualEU text
(…)

Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.

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