If you purchase a copy, we recommend selecting the option for a multi-user license so the standard can be used by more than one person in your company and printed. If you are looking for the best place to purchase a copy of the ISO 13485:2016 standard, we recommend the Estonian Centre for Standardisation and Accreditation.
Yes, you need to maintain a copy of the ISO 13485 standard as a “document of external origin.” This is needed for reference when you are making updates to procedures in your quality system. Do you have to purchase a copy of ISO 13485? If your company wants to design, manufacture, or distribute medical devices you should consider becoming ISO 13485 certified. ISO 13485:2016 is the most recent version of the standard, and it has become the blueprint for medical device company quality systems globally. Once reference to this standard is published in the Official Journal of the European Union and therefore it is officially harmonized, compliance with its clauses will grant a presumption of compliance to the corresponding requirements of the MDR/IVDR.ISO 13485 is an international standard for quality management systems that is specific to the medical device industry.
With this in mind and now the publication of this amendment explaining the relationship between EU MDR/IVDR requirements and the standard, we highly recommend manufacturers, authorized representatives, importers, and distributors in EU to apply this standard.ĮN ISO 13485:2016+A11:2021 provides regulatory requirements for your QMS that ensures consistent design, development, production, installation, and delivery of medical devices. Why is this amendment important for you as an Economic Operator?Īlthough ISO 13485:2016 is not mandatory for EU MDR/IVDR compliance, it is a commonly acknowledged standard to demonstrate the compliance to the MDR/IVDR requirement of having a QMS implemented. The standard was last revised in 2016 and in 2021 was confirmed for a further five (5) years.
The general obligations of the manufacturer in article 10 (Tables ZA1 for MDR and ZB1 for IVDR).The annex maps requirements in the MDR and IVDR regulations on: This amendment features new annexes ZA and ZB that link the requirements of the MDR and IVDR, respectively, to specific clauses of the standard. On the 9 th of September 2021, the 2021 amendment, EN ISO 13485:2016+A11:2021, was published by the European standards bodies, CEN and CENELEC.
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