March 1, 2021 IVDR

Is your Diagnostic State-of-Art?

Are you sure from IVDR perspective ?

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

If you have Diagnostics in Europe and as they fall into EU IVDR, this new regulation mentions the term “State-of-Art” a few times.

Most of the Companies did not have to deal with SOA in the past and from a commercial perspective, SOA is more   marketing buzzword than a scientific term to most manufacturers and their members.

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 medical device 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 of course Notified Bodies) can review and assess safety/performance of a diagnostic. This leads to determining the acceptability of it’s benefits and risks by comparing with other Therapeutic (not just with other Products) Options

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

  • Providing a baseline for Risk Management that to be followed in your post-marketing as well
  • It specifies your Device positioning in overall disease landscape
  • If you are depending on Equivalence, it provides criteria for justification to a predicate
  • When new Risks arise, SOA forms a baseline for you to decide Risk Benefit Analysis
  • Finally, more importantly, it defines framework and endpoints for safety/performance as that   helps for new literature inclusion/exclusion, Post marketing and PMPF for new EU IVDR

So as you can see from above, SAO establishes a reference standard that is used throughout the Clinical Evaluation and in Post-marketing as well

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

At MakroCare, SOA is lead by our Physician/Clinician teams with assistance from Scientific and Bio-chemists to arrive at right SOA for each device.


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