Data Analysis

How prepared are organizations for IVDR implementation and how is the industry tackling the biggest challenges? Based on the results of 108 study responses.

Just 15% of respondents are 'fully prepared' to hit
the IVDR deadline on 26 May 2022

"How prepared is your company to hit the IVDR deadline on 26 May 2022?"

With the IVDR deadline now less than a year away, preparations should be well under way. This is reflected in the fact that only 6% of organizations are 'not at all prepared'. Encouragingly, 53% rated their preparations as 4 or 5 out of 5, though that still leaves almost half feeling under prepared.

We asked the same question in February 2020, and as expected with an extra year of preparation, readiness for implementation has increased.

Selected other responses:

"Change of local legislation"
"Complimentary national law"
"Complete product development. CE marking is projected for Q1 2023"

"More guidance how we will get approval to commence/continue studies in Member States for CDx projects"
"Notified Bodies availability to review IVDR tech files"

55% need more guidance from the European Commission and/or MDCG to be fully prepared for IVDR implementation

"Which of the following do you need more of to be fully prepared for IVDR implementation?"

With almost half of respondents feeling under prepared for IVDR implementation, the reasons are numerous. A significant proportion revealed they need more guidance from European Commission and/or MDCG (55%), staff resource (50%) and time (47%). Additionally, with access to Notified Bodies so important, 45% need an increase in the number of NBs to be ready.

Other reasons tended to focus on the need for local legislation.

96% are planning to transfer at least some of their
portfolio of products to IVDR

"How much of your portfolio of products is your company transferring to IVDR?"

*Excluding 'Not Applicable' (45)

Only a third of respondents are planning to transfer all of their portfolio of products to IVDR, with just 4% not planning to transfer any.

Sufficient clinical evidence is the most common factor that influences which products will receive CE marking by IVDR

"Which of the below factors influenced how you chose which products to receive CE marking by IVDR?"

Selected other responses:

"Best selling"
"Clarity of the EU what they (NB) expect"
"Commercial business plan"
"Current sales level"
"Expected lifetime for product"
"Lowering of profit due to regulatory costs"

"Newer/multiple versions of products in the portfolio"
"Our manufacturing base needs to ensure that the products follow the correct process"
"Some products replaced with newer generation product"
"Time and Resource needed to be ready on time for all products in the portfolio"

When deciding how to choose which products receive CE marking by IVDR, the priority went to those with sufficient clinical evidence (59%). Cost (43%) and ability to group within a submission (34%) were still significant factors, whilst other responses mainly focused on sales levels and commercial plans.

73% of organizations are currently working with a
Notified Body for an IVD product

"Is your company currently working with a Notified Body for an IVD product?"

Almost three quarters of respondents are currently working with a Notified Body for an IVD product. This is in stark contrast to the response when we asked the same question in February 2020, when only 35% said they were working with a Notified Body. This shows the difference a year can make as organizations and Notified Bodies start to increase focus on IVDR implementation.

More than three quarters of organizations don't currently have an IVDR certified product. Of those that do, class B products are the most common (60%), compared to just 13% with certified class D products. However, many class Ds have a certificate that can be used to benefit from the grace period. More worryingly, nearly 50% of class C products are still are not certified and cannot rely on the grace period.

79% of organizations don't have an IVDR certified product

"Has your company got an IVDR certified product?"

Class B is the most common for organizations that have an IVDR certified product

"In which product class(es) has your company got an IVDR certified product?" (Of those companies that have an IVDR certified product)

Timelines and clinical requirements are the
biggest concerns with the change to IVDR

"What is your biggest concern with the change to IVDR?"

Selected other responses:

"Application of article 5.5"
"Interaction and prioritization with NCAs and NBs on companion diagnostics development and certification."
"Lack of clarity on terminology and lack of practical implementation guidance materials"
"Lack of urgency by the IVD companies to adjust their approach to satisfy IVDR Literature review and evidence management requirements in a compliant manner"

Perhaps unsurprisingly based on the responses to the readiness questions, the biggest concern with the change to IVDR is the timelines (25%). With COVID-19 having such a large impact on the industry and organizations, this perhaps explains why a quarter of respondents think timelines are stretched.

When we asked the same question in February 2020, 44% of respondents felt clinical requirements was the biggest concern, compared to 21% today.

If you could ask your Notified Body one question on IVDR
anonymously what would it be? (Selected responses)

"Why do you have so few resources?"
"How long does it take to go through the certification process?"
"Will the DoA be postponed to e.g. 2023?"
"What are the requirements for scientific literature that can be used instead of clinical testing, e.g. does the published work have to be on the actual product and does the publication have to be for a clinical study or can academic research papers be used?"
"What are you clinical competences?"
"Where no guidance on interpretation of IVDR, which will be the interpretation?"
"Will Combination drugs fall under this regulation?"
"With limited resources to assist the IVD/ MedDev companies, How can we work together to standardize optimal literature review outputs and reports to accelerate IVDR certificates?"
"When will they start accepting Class D devices?"
"How flexible will you be in terms of asking for more data/new studies and working through the new process with manufacturers vs rejecting products?"
"What is acceptable to stipulate in a PMPF plan that is not required for product approval (e.g. Near-Patient)?"

"What is preparedness of NBs for the upcoming MDR/IVDR submissions?"
"What considerations are being put into place for CE marking of cutting edge technologies such as NGS panels that use RUO instrumentation? In the United States, this follows a single site model. It is not clear what requirements will need to be met to enable use of specific RUO instruments that are validated along the NGS assay and required as part of the system."
"What is your biggest area of non-compliance that you are seeing in technical files?"
"How do they intend to review legacy products for clinical performance?"
"How many producers in this country are affected by the IVDR?"
"What's the risk of submission based on equivalence procedure?"
"Will you have the capacity to absorb the additional workload (Product/Manufacturer portfolio increase, audit, TD review and Post-Market activities) when you will be re-Notified under IVDR in order to have our products certified before the deadline (DoA)?"

Just 16% 'fully' understand the clinical requirements of the IVDR

"To what extent do you understand the clinical requirements of the IVDR?"

There is clearly a reasonable level of understanding of the clinical requirements of the IVDR, with 90% of respondents rating their understanding as 3, 4 or 5 out of 5. However, only 16% admit to a 'full' understanding. Surprisingly, this number is lower than the number of organizations that currently 'fully' meet the clinical requirements of the IVDR (22%). This perhaps suggests the team effort that goes into meeting the requirements.

22% of organizations currently 'fully' meet the clinical requirements of the IVDR

"To what extent does your organization currently meet the clinical requirements of the IVDR?"

When looking at post market surveillance requirements of the IVDR, 88% have a reasonable understanding (3, 4 or 5 out of 5), with 24% 'fully' understanding the requirements.

However, less than half (46%) of organizations either fully or nearly fully currently meet the PMS requirements.

24% 'fully' understand the post market surveillance requirements of the IVDR

"To what extent do you understand the post market surveillance requirements of the IVDR?"

14% of organizations currently 'fully' meet the PMS requirements

"To what extent does your organization currently meet the post market surveillance requirements of the IVDR?"

COVID-19 has had a huge impact on every industry around the world and this is reflected in the fact that the pandemic has had an impact on 95% of organizations' IVDR implementation. This goes some way to explaining why timelines is still the biggest concern among respondents and that almost half feel under prepared. Indeed, a third of respondents say that COVID-19 has had a 'significant impact' on their preparation.

As detailed on the following page, the pandemic caused delays to NB allocation, audits and generating clinical evidence.

The COVID-19 pandemic has had an impact on 95% of organizations' IVDR implementation

"To what extent has the COVID-19 pandemic impacted your IVDR implementation?"

What have the main impacts of COVID-19 been? (Selected responses)

"We manufacture a qPCR based kit. We barely made it through 2020 and could supply customers but there was simply no qPCR plates available to perform studies that we wanted to do."
"Delay in practical implementation."
"COVID has impacted the availability of key resources needed to implement IVDR activities as those resources have also had to work on COVID related projects which had higher priority."
"Implementing new COVID tests in product portfolio with ever changing market requirements."
"COVID has negatively impacted our ability to conduct necessary testing to meet clinical requirements as well as adversely impacted the ability to onboard resources."
"Access to patients and samples and the ability to follow GCP processes appropriately."
"Resources redirected to enabling/improving homework infrastructure. Vastly reduced workforce allowed onsite."
"There is no healthcare facility currently available or even willing to run the required clinical studies, most company staff are working remotely and important tests take much longer to complete."
"Delay in Audits, too few Notified Bodies."

"Lack of resource, home office or reduced personnel allowed in the office to perform needed tests that cannot be done in home office."
"Significant delay in the external framework starting with delayed designation of NB, delayed guidance (e.g. classification), missing framework (e.g. reference laboratories). Today's designated NB are not able to review and re-certify the current IVD on market portfolio in time."
"The main impacts have been additional post market surveillance requirements."
"1) Delays in all product registrations 2) Problems related to on/site audits (not allowed) 3) Increase of demand and lack of components supplies."
"Everything has been delayed."
"Resources originally assigned to IVDR remediation were redirected to COVID-19 IVD test development and manufacture."
"New multidisciplinary department within the company in order to fullfil all the requirements has been created."
"Problems to find laboratories to do clinical performance studies"
"Inability to generate clinical evidence as the COVID-19 pandemic has decreased testing in oncology labs."

Respondents are unsure on whether the Commission will
change the date of application of the IVDR

"Do you think the Commission will change the date of application of the IVDR as per the MDR?"

With COVID-19 having a significant impact on organizations' preparation and many feeling under prepared for IVDR implementation, there is the possibility of the Commission delaying the date of application as happened with the EU MDR. However, respondents are unsure this will happen, with similar numbers thinking it will (31%) and won't (28%), whilst a higher proportion (41%) don't know.

In your opinion how do you see the IVD industry
changing in the next 10 years? (Selected responses)

"There could be a smaller number of players as the regulations (clinical and PMS) are a high bar to meet for start up companies."
"Less innovative products will be launched for the IVD market, since only multinationals and relatively big companies will have the required resources to do this."
"Survival of the fittest. Only the biggest players will remain."
"More regulation."
"Increased safety, functionality and benefit for users and patients."
"Fewer tests; but potentially better quality tests."
"Increasing regulations, requiring increased resourcing within quality functions and increased understanding & workload for functions across the organization. Also higher demand for transparency from manufacturers further solidifying the need for companies to digitalize from databases to eQMS while simultaneously increasing cybersecurity."
"Process will continue to evolve to satisfy patient safety needs."
"It will be far more time consuming to get new products and implement changes to products under the new regulation."

"There will be more software applications which will need adjustment for moving them through the CE marking process and more recognition of the agile design and development process. I sincerely hope the time to market that will inevitably be increased with the IVD Regulation will not result in small innovative companies being able to bring devices to market."
"I foresee many companies leaving the EU due to the new regulations."
"Problems for mid-size companies with many legacy products." "Polarization in very large companies on one hand and small innovative companies on the other hand. Less CE marked products from companies outside the EU."
"More reliance on software and how software is designed and developed."
"IVDR will lead to a significant market clean up since many small businesses will not find a Notified Body or will not be able to pay the increased fees necessary for the extensive clinical documentation and consultation fees."
"I'm afraid only big manufacturers will survive, and they'll raise prices."