SN EN ISO 13485/A11:2021 Medical devices — Quality management systems — Requirements for regulatory purposes Amendment 11
Alignment with European Compliance for MDR and IVDR
It is the European addition to ISO 13485:2016. This amendment helps demonstrate conformity with the requirements of European regulations MDR and IVDR. Essentially, it explains how certain parts of the MDR and IVDR can be fulfilled through the application of SN EN ISO 13485.
When was ISO 13485 last updated?
The international standard organization (ISO) published the latest international edition of ISO 13485 in 2016. And this international part remains unchanged.
The European Union published EN ISO 13485/A11:2021 in 2021. However, EN standards are not available for direct purchase. Amendment A11 is only accessible as a national standard. In Switzerland, for instance, it is known as SN EN ISO 13485/A11:2021. All CENELEC member countries are required to publish the amendment without changes, meaning that all national publications, such as DIN in Germany, contain the same content.
What is new SN EN ISO 13485 A11 2021?
In detail, the CENELEC added European foreword and the informative appendix ZA and ZB.
New European foreword
New informative Annex ZA pointing to (EU) 2017/745 MDR
Correspondence between this European standard and Article 10
Correspondence between this European standard and Annex IX
New informative Annex ZB pointing to (EU) 2017/746 IVDR
Correspondence between this European standard and Article 10
Correspondence between this European standard and Annex IX
In standardization in general, one document after the other must be incorporated in order to have the correct final version. In this particular case, A11:2021 totally overwrites AC:2020. But keeps the text of ISO 13485:2016 as EN ISO 13485:2016 without any modification.
What is SN EN ISO 13485/AC:2020?
Is the corrigendum AC:2020 and ISO 13485:2016 point to the old regulations of MDD and IVDD. When your products are still certified under MDD and IVDD, then this corrigendum still is applicable.
SN EN ISO 13485/AC:2020 Changes to European parts of EN ISO 13485:2016
This corrigendum changes the European foreword, and the informative European Appendixes ZA-ZC. In detail, this corrigendum incorporates the following corrections:
Combination of EN ISO 13485:2016 and the corrigendum EN ISO 13485:2016/AC:2018. Which has superseded (replaced) EN ISO 13485:2012 and CEN ISO/TR 14969:2005.
Changes to the informative Annex ZA. Where the correspondence to the amended 90/385/EEC on Active implantable medical devices (AIMD) is described.
Changes to informative Annex ZB: Correspondence to the amended EU Directive 93/42/EEC on Medical devices (MDD).
Changes to informative Annex ZC: Correspondence to EU Directive 98/79/EEC on in vitro diagnostic medical devices (IVDD).
SNV publishes the three publications separately.
What is DIN EN ISO 13485:2021-12?
Beuth has published a German consolidated version of EN ISO 13485:2016 + AC:2018 + A11:2021.
The publication now carries the updated date of December 2021, which can occasionally lead to some confusion. However, having consolidated versions is beneficial for the industry, as it simplifies understanding the changes in regulations and the corresponding harmonized standards, which can be complex.
Why is the benefit of harmonised standards?
By fulfilling the requirements of ISO 13485, you automatically comply with certain sections of the MDR and IVDR. Amendment A11:2021 highlights the common requirements between ISO 13485 and these regulations, making the interpretation of the standards clearer.
Article 8 Use of harmonised standards
1. Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.
The first subparagraph shall also apply to system or process requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up (‘PMCF’). MDR and IVDR Article 8 (1)
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What are the topics for ISO 13485?
ISO 13485 covers a wide range of topics essential for the quality management of medical devices. These include risk management, product lifecycle processes, regulatory compliance, documentation control, design and development procedures, manufacturing processes, and post-market surveillance. ISO 13485 also addresses supplier management, corrective and preventive actions, and internal audits to ensure continuous improvement and compliance with regulatory standards. The topics within ISO 13485 are all focused on maintaining high-quality standards throughout the production and delivery of medical devices.
What is ISO 13485 in simple words?
ISO 13485 is a globally recognized standard that defines the requirements for a quality management system specific to the medical device industry. In simple terms, it ensures that companies consistently design, develop, produce, and deliver medical devices that are safe and meet regulatory requirements. ISO 13485 focuses on risk management, product safety, and maintaining effective processes to achieve compliance with the legal standards of various markets.
How to prepare for an ISO 13485 audit?
Preparing for an ISO 13485 audit involves several steps to ensure compliance with the standard. First, review your organization's existing quality management system to ensure it aligns with ISO 13485 requirements. Ensure all documentation, including procedures, records, and training materials, is up to date and accurately reflects your processes. Conduct internal audits to identify any gaps or non-conformances and take corrective actions. Finally, train your staff to ensure they understand ISO 13485 requirements and are prepared to demonstrate compliance during the audit. The goal is to demonstrate that your quality management system complies with ISO 13485 standards for medical device production. ColabON's intelligence can automate parts of this task.
What is required for ISO 13485?
To meet the requirements of ISO 13485, a company must establish and maintain a quality management system specifically designed for the medical device industry. This includes having well-defined procedures for product design, manufacturing, risk management, regulatory compliance, and customer feedback. Documentation control, traceability of materials and processes, and consistent monitoring of quality through audits are also required. The organization must ensure that its quality management system meets the stringent requirements of ISO 13485 to guarantee the safety and efficacy of its medical devices.
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