Technical documentation section 4. GSPR and applied standards:
4.1 List of applied standards
This document provides a comprehensive list of harmonised and non-harmonised standards that have been applied in the development, testing, and manufacturing of the medical device, in accordance with Regulation (EU) 2017/745 (MDR). The standards listed herein support conformity with the General Safety and Performance Requirements (GSPRs) as set out in Annex I of the MDR.
Structure of the list
The list of standards includes information such as the standard number, title, publication year, status (e.g., harmonised, state of the art), and the specific purpose for which the standard has been applied. Where applicable, the relation of each standard to the GSPRs is indicated.
Use of harmonised standards
Harmonised standards provide a presumption of conformity with relevant legal requirements. The use of harmonised standards is voluntary; however, their application is highly recommended as they are widely accepted by Notified Bodies and regulatory authorities.
All harmonised standards listed are referenced in the Official Journal of the European Union (OJEU). When available, the most recent version cited in the OJEU has been applied.
Use of non-harmonised standards
In cases where no harmonised standard is available or applicable, state-of-the-art non-harmonised standards may be used to demonstrate compliance with the MDR. Such standards may include ISO, IEC, ASTM, or other internationally recognised publications.
Examples of applied standards
- ISO 14971:2019 - Application of risk management to medical devices
- IEC 60601-1:2005+A1:2012 - Medical electrical equipment – General requirements for basic safety and essential performance
- EN ISO 13485:2016 - Medical devices – Quality management systems – Requirements for regulatory purposes
- EN 1041:2008+A1:2013 - Information supplied by the manufacturer of medical devices
- ISO 10993 series - Biological evaluation of medical devices
- EN ISO 15223-1: Symbols to be used with medical device labels, labelling and information to be supplied
- EN 62366-1: Application of usability engineering to medical devices
Maintenance of the list
The list of applied standards is reviewed and updated regularly as part of the manufacturer's Quality Management System. Updates may occur in response to changes in legislation, revisions of standards, or internal process improvements.
Traceability to GSPRs
Each applied standard is mapped to specific GSPRs as part of the GSPR checklist. This traceability provides clear evidence of how compliance with MDR requirements is achieved through the application of standards.
