What is EN ISO 13485?
Implementing and maintaining a strong quality management system (QMS) for your medical devices, products, and services is critical to the success of your company. Your QMS’s EN ISO 13485 certification displays your dedication to working at a worldwide level. As ISO 13485 medical device consultant we assist our clients in creation of documents for the ISO 13485 certification. On-site audits are part of the EN ISO 13485 certification process and they assess your quality management system’s competence and reliability. In the areas of design, development, production, and customer service, our professionals examine both the practical implementation and the degree of effectiveness.
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Amendment
In September 2021, a revision to EN ISO 13485:2016 – Medical Devices – Quality Management Systems – Requirements for regulatory purposes – was released. The European Foreword, as well as Annexes ZA, ZB, and ZC, are all replaced by this revision. The relationship between the clauses of the standard and the requirements of the three European Directives for medical devices – the Directives for active implantable, medical devices, and in vitro diagnostics – was shown in Annexes Z from the previous edition of the standard.
These three Annex Zs have been replaced by two new Annex Zs, designated ZA and ZB, which determine the connection between the standard’s clauses and the requirements of the Medical Devices Regulation ((EU) 2017/745) (MDR) and the In vitro Diagnostic Medical Devices Regulation ((EU) 2017/746), respectively (IVDR).
The introduction to each Annex Z specifies that the standard is based on the acceptance of an international standard and hence does not cover all European quality management system standards (QMS). As a result, manufacturers and conformity assessment organizations must include the European Regulation’s QMS criteria in EN ISO 13485 processes.
The information supplied in the tables in Annex Zs will aid this process by indicating whether the standard’s content covers, partially covers, or does not cover European standards. The European Regulations, for example, demand that clinical evaluation, risk management, post-market surveillance, and the assignment of a unique device identity be included in the QMS. Although EN ISO 13485 demands that these processes be integrated into the QMS in compliance with regulatory requirements, the standard does not explicitly incorporate the details of the European Union regulatory requirements.
Furthermore, the introductions to the Annex Zs state that the EN ISO 13485 meanings may differ from the precise definitions in the European Regulations. The definitions in the regulations take precedence to support European obligations.
Annexes ZA and ZB to EN ISO 13485 contain 3 tables.
These tables show the connections between the standard’s provisions and the regulatory requirements QMS in the:
- Article 10 outlines the manufacturer’s general obligations.
- Evaluation of technical documentation and conformity assessment based on QMS (Annex IX); and;
- Product conformance verification is used to assess conformity (Annex XI).
Article 10 and Annexes IX and XI of the European Regulations, in addition to QMS requirements, offer explanations of regulatory processes and actions done by the notified entity, competent authority, and European Commission. These actions are not covered by EN ISO 13485 since they fall outside of its scope.
For Expert Consulting Services For Medical Devices Regulations
The publication of the revision to EN ISO 13485 opens the door to harmonization of EN ISO 13485 as a presumption of conformance with European Regulations requirements, with the extent to which the requirements are covered being detailed in Annex Zs. The standard is expected to appear in the next list of harmonized standards to be published in the Official Journal. For the certification of ISO 13485 manufacturer needs an experienced medical device regulatory consultant who can create documents and obtain a certificate from the correct certified body.
