February 24, 2022 IVDR

Is your Diagnostic State-of-Art? Are you sure & you think you can convince you NB?

You being “SURE”, or your company thinks their Products have SOA does not help as it needs to be “Documented” in Performance Evaluation to get an OK from Notified Bodies.

Most of the Companies did no had to deal with SOA in the past and from commercial perspective, SOA is more marketing buzzword than scientific term to most manufacturers and their members. It’s not their fault on this mis-understanding as EU IVDR does not clearly define “State-of-Art”.

What does “State-of-the-Art” actually mean?

While the EU IVDR does not define state of the art, ISO 14971:2012 defines it to some extent. 14971 is a risk management international standard (most manufacturers know this standard well) and it outlines state-of-the-art as “best practices as used in other devices of the same or similar type.”

A joint working group involved in revising ISO 14971 and ISO/IEC CD Guide 63 proposed the definition for state-of-the-art: “Developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience.”

And this add-on note is also attached which clarifies this a bit: “State-of-the-art embodies what is currently and generally accepted as good practice. The state of the art does not necessarily imply the most technologically advanced solution.”

So, think SOA as “a current state of all competitive treatment options.”

Why SOA is important during Clinical Evaluation?

SOA provides the “Context” in which a manufacturer (and ofcourse Notified Bodies) can review and assess safety/performance of a device. This leads to determining the acceptability of it’s benefits and risks by comparing with other Therapeutic (not just with other Devices) Options.

Most manufacturers are doing this in isolation. Please note that SOA is central to entire Clinical Evaluation. SOA helps in:

(a) providing base line for Risk Management that to be followed in your post-marketing as well.
(b) It specifies your Device positioning in overall disease landscape.
(c) If you are depending on Equivalence, it provides criteria for justification to a predicate.
(d) When new Risks arise, SOA forms a baseline for you to decide Risk Benefit Analysis.
(e) Finally, more importantly, it defines framework and endpoints for safety/performance as that is the base for new literature inclusion/exclusion, PMS summaries and PMPF for new EU IVDR.

What will SOA consist of?

SOA section should include clinical background, medical condition, therapeutic alternates as well as other devices and their performance / safety profiles. It should also include applicable standards and guidance documents and outline hazards and risk reduction approaches as well.

Why Notified Body is interested in this?

In the new European MDR and associated MEDDEV 2.7/1, you are expected to demonstrate that you have conducted a thorough analysis of the current SOA. Notified Bodies are increasingly looking to see that you have performed an in-depth assessment of alternative treatment methods for the same indications-thus, you can expect more due diligence during your next surveillance audit.

At MakroCare, SOA is lead by our Physician/Medical teams with assistance from Scientific and Technical team to arrive at right SOA for each device. Please let us know (medtech@makrocare.com) if you need any advice or no-obligation suggestions on any of your devices to establish Risk Benefit “Scientifically”.

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