Set to apply from May 2022 on, the IVDR proposed progressive roll-out has been adopted by the EU as a very welcome Christmas gift.

Essential to realize thought is that the amendment does not change the requirements of the IVDR but only extends the implementation for certain devices. New devices or CE-marked devices not requiring NB involvement must still meet the 26-May-2022 deadline, and the requirements on the performance evaluation still stand, so the IVDR rollercoaster will soon take off!

So what is the challenge?

Referencing the amendment, we are moving from a situation where about 3300 IVD’s require NB involvement for their conformity assessment to a situation with over 24 000 requiring so. This while at the same time the number of NBs went down substantially, so there is a substantial shortage in resources in this respect.

But is that the only issue? Based on several conversations lately, and looking at this from a clinical perspective, we are facing another one, and that concerns the

performance evaluation,

or rather the lack thereof. The performance evaluation is meant to show that any (clinical) performance claim is subtantiated by sufficient qualitative evidence, and that the device performs as intended. Given the upclassification of so many devices, however, multiple manufacturers are new to or relative unfamiliar with this process, and I cannot but emphasize enough that they shall

“… plan, conduct and document a performance evaluation”

per Article 56 and Annex XIII of the IVDR, and that NBs will review

“… manufacturers’ technical documentation, in particular the performance evaluation documentation”

So a performance evaluation plan should be created, that includes key aspects such as

  • the device with its performance claims (accuracy!)
  • the target patient group(s)
  • a justification as to why certain analytical, clinical, or other performance requirements are not considered applicable, or when required,
  • the data that shall be generated in (clinical) performance studies, and
  • the PMPF plan.

Especially on the last 2 bullets there appears to be some confusion, but let me help you out of your dream: a performance evaluation is NOT the same as a (clinical)

performance study

(or investigation, or trial). Studies are a way to generate the data needed for the evaluation, and in case of IVD’s we have

  • the analytical performance studies that typically shall always be performed to generate data on the device’s analytical performance, and
  • the clinical performance studies that shall be performed, unless due justification is provided, to generate data regarding performance in clinical practice.

When necessary to substantiate device performance (even more so under the IVDR), such studies need to be conducted in line with international ethical and regulatory guidance, such as the Declaration of Helsinki, ISO 14155 (GCP for medical device on human subjects, and be aware that the IVDR references an outdated version!), and ISO 20916 (see flow chart).

Unfortunately at this stage the amount of

EU guidance documents

on the performance evaluation under the IVDR is limited in spite of the nearing deadline. As a starting point, however, and in line with the IVDR

“… guidance developed for in vitro diagnostic medical devices at international level, in particular in the context of the Global Harmonization Task Force and its follow-up initiative, the International Medical Devices Regulators Forum, should be taken into account …”

we do have IMDRF guidance (pretty old thought!) and the COVID-19 TEST MDCG that was published last year. So besides Annex XIII, there are tools on the performance evaluation process, and indicating what steps should be taken and documented. With respect to

COVID-19 diagnostic devices

and press release on the adoption of the IVDR amendment, I found Stella Kyriakides’ comment that

“The pandemic has at the same time highlighted the vital need for accurate diagnostics and a resilient regulatory framework for in vitro medical devices. The amendment of the In Vitro Diagnostic Medical Devices Regulation will ensure that crucial medical devices, such as COVID or HIV tests, continue to be available and safe” 

quite interesting: While, indeed, the pandemic emphasized the need for a smooth functioning regulatory system, to me it also illustrates – again – some of its shortcomings. Referencing Ines’ recent blogpost on this topic, COVID test devices have substantial flaws for multiple reasons, but in light of the performance evaluation I find it frustrating that one of the reasons is that devices have been benchmarked with symptomatic people rather than a-symptomatic ones (wrong target patient group!). This while at the moment they are often used by a-symptomatic people.

In short,

there is a lot of clinical work ahead of us ensuring performance evaluations for the IVD’s are in order and substantiated by adequate and qualitative clinical evidence. If not started to date, you better start preparing yourself right now, because the deadline is closer and performance studies take longer than you think, while the rollercoaster is about to take off.

Feel free reaching out in case of questions or support needed, and in the meantime I wish you a good and above all healthy New Year!


As updated 05-JAN-2022

About Annet Muetstege - Visscher

My name is Annet Muetstege and I am a clinical research expert, based in The Netherlands, with over 25 years of experience in all aspects of clinical evidence planning and execution especially in medical devices. I am the co-founder of Applied Clinical Services.
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