Updated Version Of EN ISO 13485 Now Officially Harmonized Under MDR Along With Other Standards

Article posted on 5 January 2022 on Medtech Insight
Author: Amanda Maxwell | Source of Original Article

Executive Summary

The New Year has seen the official publication of a series of long-awaited new medtech standards, including some that are critical to large swathes of the medical device industry.


It’s official! The updated version of the EU quality system standard EN ISO 13485, which is relevant for the whole of the medtech industry, is now formally recognized as a “harmonized” standard in the context of the EU’s Medical Device Regulation.

It has been published in the Official Journal of the EU as giving a “presumption of conformity” with the MDR along with seven other standards, including the medical device symbols standard and standards on biological evaluation of medical devices.

The amended EN ISO 13485 and the seven other newly harmonized standards that have now been published offer manufacturers a means of demonstrating conformity with the general safety and performance requirements of the new MDR to which the standards are linked. Five are newly adopted standards and three are amended standards 

This brings the total number of standards harmonized in the context of the MDR to 14, with the expectation that new lists will be published in the OJEU every three months. The titles of the other five standards published as harmonized in the OJEU were published in July, some of which are also harmonized under the IVDR. (Also see “First Harmonized Standards Published For Both MDR And IVDR” – Medtech Insight, 20 Jul, 2021.)

A commission implementing decision adding five new IVD references to the lists of harmonized standards under the IVDR is expected to be published on 7 January.

Also, according to the European Commission, the harmonized version of the risk management standard, EN ISO 14971:2019 with its amendment A11:2021 is likely to be published in the OJEU in March or April, along with other new harmonized standards. The amendment, the commission says, has recently been made available. December 28 was the deadline for the public enquiry on two documents intended to link the standard with the MDR and IVDR.  (Also see “Progress In Aligning EU’s Risk Management Standard With New MDR And IVDR” – Medtech Insight, 15 Dec, 2021.)

The Latest Standards

The newly adopted, revised standards published on 5 January 2022 in the OJEU are as follows:

Standard ReferenceStandard Title
EN ISO 10993-9:2021Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
EN ISO 10993-12:2021Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
EN ISO 13408-6:2021Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021)
EN ISO 14160:2021Sterilization of health care products – Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives – requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)
EN ISO 15223-1:2021Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021)
EN ISO 17664-1:2021Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

The following amended standards were also published on 5 January 2022:

Standard ReferenceStandard Title
EN ISO 11737-1:2018Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018) EN ISO 11737-1:2018/A1:2021
EN ISO 13485:2016Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/A11:2021
EN IEC 60601-2-83:2020Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment EN IEC 60601-2-83:2020/A11:2021.

(The references in brackets are the previous versions of the standard, or the basis for the standard.)

Delay

The publication of the updated harmonized standards is much later than had originally been planned due to bureaucratic challenges at EU level. Thankfully, the delay has not been as disruptive as it could have been. This is because the vast majority of medical devices that are able to are making use of the grace period.

Manufacturers using the grace period can use the standards harmonized under the medical device directives for now, and are expected have time to migrate to the MDR/IVDR standards towards the grace period deadline of 26 May 2024, when the new (or revised) standards should have been harmonized under the new regulations.

In total, some 200 medtech standards are due to be harmonized in the context of the MDR and IVDR.

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