IVDR Insider Explains 5 Critical Impacts of the EU Clinical Evidence Requirements

We recently published an exclusive MedTech Intelligence interview with Carlos Galamba, Vice President, Intelligence and Innovation with RQM+. Galamba is an IVDR expert who spoke at the 2022 RAPS Convergence during the panel discussion "Lessons Learned from the Implementation of the EU Regulations."

For many manufacturers of IVD devices now on the European market, meeting the evidence required of the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will require tremendous work. With the shortage of notified bodies, numerous outstanding guidance questions, as well as skyrocketing costs, and an industry-wide resource shortage, many industry stakeholders are asking, “What’s going to happen?”

Before joining RQM+ last year, Galamba was a technical reviewer, technical team manager, and clinician with BSI, a notified body. Before BSI, he worked as a lead scientist with the National Health System in the UK, working in transfusion medicine (i.e., a very high-risk area that involves blood donations, compatibility between patients and donors, transplants, etc.).

Below we have recapped five reasons why IVDR insider Galamba thinks the regulation matters, the challenges created by the EU clinical evidence requirements, and its impact on the industry.

#1 What's Changed Under IVDR

According to Galamba, one primary difference between IVDR and the previous IVD Directive is that manufacturers can no longer claim that the device is used for diagnosing an illness or multiple clinical conditions without the evidence to fully substantiate those claims.

"As much as 90% of devices now need to get certified by notified bodies in Europe. As a result, he said, there's much more scrutiny on the intended purpose.”

#2 What's the Biggest Stumbling Block

However, he said, a major issue presents itself in which there have been several IVDR certificates issued, and the notified bodies all agree that one of the most common findings is an insufficient demonstration of clinical evidence.

“[U]nder the IVDR, there's a whole new framework for clinical evidence that's legally required, including analytical performance, scientific validity, performance evaluation plans, performance evaluation reports, clinical performance reports, etc. There are several new deliverables that were not necessarily called out before but are now formally required under the IVDR.”

#3 What If There Are Clinical Evidence Gaps?

In his view, collating and/or generating the necessary evidence for IVDR compliance is very challenging for many companies. So unless they have the right expertise in-house or external support, generating all necessary data for IVDR compliance can be a minefield.

"When there are clinical evidence gaps, the technical files just don't get approved."

Thus, prior to submitting, IVD manufacturers must make sure they approach the notified body with a very robust set of data, with all of the analytical and clinical performance studies completed and with sufficient sample sizes backed up by appropriate statistical rationales. Additionally, all technical documentation should be aligned with IVDR requirements, and clinical evidence must demonstrate a complete support of a device’s intended purpose and the intended clinical benefit(s).

#4 Will Devices Be Removed from the Market

Under the new timelines, IVDs will need to progress to the IVDR sooner or later over the next three to five years. Thus, there is a real threat that some devices will disappear from the market because manufacturers are underestimating how long certification really takes and how complex IVDR is in comparison to the IVDD.  

"From my experience working in consultancy and with notified bodies", said Galamba, "some manufacturers are still leaving their IVDR transition to the very last minute"

#5 Why is IVDR needed?

There needs to be sufficient evidence for devices when something is submitted to an authority for approval. For example, a technique called gel card agglutination, which is used in transfusion medicine to identify if a patient is cross-matched (positive or negative) with a particular blood donation. It has been around for ages. Thus, it’s precisely because hospitals worldwide rely on this technology – often to save lives – that there needs to be ongoing evidence that it works.

"I remember at the time needing access to a transfusion card very quickly for a particular patient that was in the operating theater, and not being able to use it because of  a batch defect. An issue that could have been avoided through better product release controls and enhanced release specifications.. So I needed to use a product in a life-threatening situation, and I didn't have access to it"

Even though it may be the best device out there, without robust evidence to support it and strong safety and performance data, the risk is too high, and regulatory frameworks, by nature, are very risk-averse.

* * *

Read the full interview and watch a 1-minute video clip with Carlos Galambra on  Medtech Intelligence EU MDR and IVDR Resource Center here.