14 October 2020 - The National Standards Authority of Ireland (NSAI) has adopted December 2020 as the expected implementation date for EN ISO 14971:2019.

By: Ashley Clark, MSc, RAC, R&Q Senior Specialist

Notified Bodies (NBs) throughout the European Union (EU) are grappling to define for State of The Art (SoTA) before EU 2017/745, the “Medical Device Regulation” (MDR), implementation. NBs are relying on standards as the metric to which applicants are measured for compliance and current state of the art. In the absence of published harmonized standards from the European Committee for Standardization (CEN) and the European Committee for Electro-technical Standardization (CENELEC), in addition to the rapidly approaching MDR date of application (DoA), NBs are having to come to their own practical conclusions as to what this metric will look like for certification.

In this vein, the Irish NB, National Standards Authority of Ireland (NSAI), has adopted December 2020 as the expected implementation date for EN ISO 14971:2019. This is in contrast to British NB BSI with the expectation that clients implement the 2019 iteration of EN ISO 14971 by the next audit.

The impact on industry

The MDR application date was delayed one year to 26 May 2021 due to the circumstances created by the COVID-19 pandemic. Even with this delay, there are still no harmonized standards for the regulation in the Official Journal of the European Union (OJEU) at present. NBs are now tasked with determining compliance thresholds and strategies for certifying products under MDR and maintaining certification under Medical Device Directive (MDD). NBs are taking on this task at the risk that standards they adopt for demonstration of SoTA claims are not included in the publication of the OJEU as being harmonized to EU 2017/745 at such time that this information becomes available.

As we approach the DoA for MDR, the 13 designated NBs need to support stakeholders by communicating their expectations for certification to the new regulation and maintaining the Directive 93/42/EEC certificate during surveillance audits for the remainder of their validity.

What does this mean for current CE Certificate Holders?

There is no obvious impact for those with currently CE Marked devices under certificates from NSAI that will continue to be marketed under MDD until 2024. NSAI should continue to allow MDD certified devices to continue to comply with harmonized standards present in the OJEU for Directive 93/42/EEC.

What does this mean for MDR applicants?

NSAI’s current position has been expressed that if the most current standard was published within 12 months of the application date, the preceding standard may be used to produce evidence of conformity. However, there is an expectation that a gap assessment be documented and submitted with the application identifying and justifying differences between the earlier version of the standard and the most current.

For any standard published beyond 12 months from the date of application submission, the client must produce objective evidence of conformity with the most recent standard. For EN ISO 14971, this means complying with the version published in December 2019 as soon as May 2021.

Why is this such an impact for ISO 14971, specifically?

The 2019 iteration of EN ISO 14971, referred to as 14971 from here on, was published in December 2019. This is the most current revision of the standard, therefore presumed to be SoTA. Now that we are in the fourth quarter of 2020, this could require companies planning to apply for certification in the early months of application of MDR to bring all applicable risk documentation to the current standard. This will impact applications and technical documents submitted for NSAI review to MDR.

For stakeholders planning to be assessed for conformity for MDR in the spring, if risk documentation currently exists only in compliance with EN ISO 14971:2012, this could open up the risk for non-compliance and impact certification preparedness.

What is the impact on MDR application?

This does not create any new requirements for compliance to 14971. The updates related to the 2019 version are not changing because of this truncated implementation date. The same assessments, updates, and requirements will still include reviewing the company-wide Risk Management System (RMS) and performing an appropriate gap assessment between the two standards; this just means it needs to be completed sooner than the three year transition period for the standard. Documents impacted could span from existing standard operating procedures (SOPs) and failure mode effects and analyses (FMEAs) to the creation of new risk-benefit analysis.

There are some new definitions in the 2019 iteration of the risk management standard. This includes definitions for “state of the art” borrowed from ISO/IEC Guide 63:2019, benefit, and reasonably foreseeable misuse. These will ripple out of the risk documents and into the Technical Documentation, especially the General Safety and Performance Requirements (GSPR) for compliance to MDR.

Conclusion

NBs are leveraging what SoTA standards are available to prepare for the DoA for MDR in May 2021. EN ISO 14971:2019 has become a focal point for NSAI because it is one of the most recently published standards. It could be said that moving forward, performing assessments for conformance to this standard might be risky since it is not harmonized at this time. However, given that this is an EU adopted standard (EN), it is likely a nominal risk. What remains to be seen will be how quickly stakeholders can execute if they were intending to submit for review for MDR with EN ISO 14971:2012 risk documentation.

Having trouble interpreting and implementing all of the new state of the art requirements? R&Q has answers and is available to help you keep your devices safe and effective... and your business grow. Our dedicated (and highly qualified/proficient) team stays on top of the newest regulations, industry trends, and uses our industry connections to grasp what our competition might not. Learn more about how we can help here.

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Sources:
[1] National Standards Authority of Ireland (NSAI). Client Communication regarding the use of Standards to demonstrate State of the Art. Accessed 8 October 2020. www.nsai.ie 
[2] BSI. BSI Medical Devices: Webinar Q&A. ISO 14971:2019 Risk Management for Medical Devices. Published 13 November 2019. Accessed 8 October 2020. https://www.bsigroup.com/globalassets/meddev/localfiles/en-gb/webinars/bsi-md-risk-management-for-medical-devices-webinar-qa-131119-uk-en.pdf
[3] BSI. MDR Date of Application delay confirmed. Published 21 April 2020. Accessed 6 October 2020. https://www.bsigroup.com/en-US/medical-devices/News-center/E-updates/2020-news/mdr-date-of-application-delay-confirmed/ 
[4]
European Commission. Internal Market, Industry, Entrepreneurship and SMEs. Harmonised Standards Medical devices. Directive 93/42/EEC. Accessed 8 October 2020. https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
[5] MedTech Europe. Position Paper. Use of international generally acknowledged state-of-the-art standards in the absence of harmonised standards under the IVDR and MDR. Accessed 8 October 2020. https://www.medtecheurope.org/wp-content/uploads/2020/03/20200225_PositionPaper_MTE_State-of-the-art-standards-in-the-absence-of-harmonised-standards_PUB.pdf
[6] ISO. ISO 14971:2019 Medical devices — Application of risk management to medical devices. Published December 2019. Accessed 8 October 2020. https://www.iso.org/standard/72704.html
[7] ISO. ISO/IEC Guide 63:2019, 3.18. Guide to the development and inclusion of aspects of safety in International Standards for medical devices. Accessed 8 October 2020.  https://www.iso.org/obp/ui/#iso:std:iso-iec:guide:63:en
[8] European Committee for Standardization. What we do? Accessed 9 October 2020. https://www.cen.eu/work/Pages/default.asp

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