In the medical device industry, standards play a vital role in product conformity while also helping Manufacturers synchronize with requirements of medical device regulatory bodies around the world. Product conformity to various national and international standards, as applicable, is important not only in the design and manufacture of medical devices but also to sell a product in different jurisdictions. However, it’s not just enough to comply with the standards, but it’s important to be aware of the changes to the standards and comply with the latest accepted versions, depending on the target country. 

With great knowledge in various areas such as quality management, regulatory approvals, clinical evaluation process, and product documentation, Elexes has been consistently assisting its valuable clients in implementing QMS and other medical device standards and helping revamp systems to comply with the latest ones.

What are the major standards that underwent recent revisions? 

In the year 2021, in addition to the transition to other standards, Elexes helped many companies to transition and comply with about eleven medical device standards that were revised and/or newly established. The hyperlinked document features the standards that were revised in 2021, and some key highlights of these are as follows: 

ISO 10993-12:2021(en) provides guidelines for the preparation of samples and requirements for selecting the reference materials while performing medical device testing. 

ISO 10993-23:2021 describes the process for assessing the medical devices and their constituent materials concerning their potential to cause irritation.

The prerequisites for the analysis of absorbable medical devices during a biological risk assessment based on ISO 10993-1 are detailed in the recent standard, ISO /TS 37137-1:2021.

IEC 60601-1:2021 SER lists the requirements for medical electrical equipment taking into consideration features such as basic safety and essential performance and also contains amendments that were released previously.

ISO 20417:2021, Medical devices – Information to be supplied by the manufacturer, provides requirements to meet products related information that is the same across all devices globally. This will reduce the burden involved in the compliance of regulatory processes related to details provided by the manufacturer of the medical devices. 

In contrast to its previous version i.e ISO 1041:2008, ISO 20417:2021 is more exhaustive in detailing the “accompanying information” that manufacturers have to provide when selling a medical device. Accompanying information can include Instructions for Use, the Label (Device/Package), technical description, installation guide, etc. Additionally, the standard also provides the conditions under which a Label shall not be put on the device.

ISO 11737-1:2018/AMD 1:2021 details prerequisites and gives recommendations on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material, or package.

ISO 15223-1:2021 details symbols to be used while conveying information for the supplied medical device. The standard is also applicable to symbols that are available throughout the world and need to satisfy various medical device regulatory requirements.

As compared to the 2016 version of ISO 15223, the 2021 version includes additional symbols, for instance, the “UDI” symbol, the “Translation” symbol, the “Medical Device” symbol, etc. 

It is noted that the US FDA has already adopted the 2021 version of the ISO 15223 standard under the List of Consensus Standards and the EU has included this standard under the “List of Harmonized standards” dated January 5, 2022.

The details to be provided by the medical device manufacturers for the processing of critical or semi-critical medical devices and for medical devices that are considered to be sterilized are explained elaborately in the ISO 17664-1:2021 which was published in July 2021. It also covers requirements for processing before using or reusing a medical device.

ISO 13485:2016 details requirements of QMS for medical devices. The latest amendment “BS EN ISO 13485:2016/A11:2021” released in September 2021 has annexes that analyze the gaps between the clauses of the 13485 standards and the requirements of the EU MDR 2017/745 & EU IVDR 2017/746.

Further, as per the latest list of Harmonized standards released by EU dated January 5, 2022, the ISO 13485:2016/A11:2021 is included in the list. Hence, manufacturers can confidently make use of this amendment for aligning with the Quality Management System requirements as per MDR 2017/745 and IVDR 2017/746 regulations.

IEC 80001-1:2021 contains important changes when compared to its predecessor concerning risk management while using connected health software and/or IT systems, taking into account key features such as safety, effectiveness, and security. IEC 80001-1:2021 replaced the first edition that was released in 2010.

BS EN ISO 14971:2019+A11:2021 replaced BS EN ISO 14971:2019 and the amendment provides annexes for comparison of this risk management standard with the EU MDR 2017/745 and EU IVDR 2017/746. 

Puzzled by various standards, regulatory requirements, and updates relevant to your medical device? 

You are not alone! Elexes is helping many companies across the world to overcome these hurdles to place their medical devices in the market successfully and help maintain compliance at the post-market stage. Please reach out to jennifer@elexes.com for more information and we will be happy to assist you!

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