The transition from the In Vitro Diagnostic Medical Device Directive (IVDD) to the In Vitro Diagnostic Medical Device Regulation (IVDR) is not something to be ignored. Some estimates say that 85% of IVDs self-certifying under IVDD regulation will now be required to submit documentation according to IVDR.
Here are three of the biggest changes between IVDD and IVDR and how they might impact your IVD success.
IVDR Guidance on Risk Reclassification
First and foremost, IVDR represents a whole new level of regulation when compared to IVDD. The latest developments in the EU are not a modest retooling of preexisting guidelines, but rather a fresh introduction of highly detailed, highly inclusive regulations. What’s the bottom-line result? More devices need more documentation.
This is critical information for organizations either planning out the development of a device portfolio or focusing on the success of a single IVD innovation. IVDR also requires every device to be evaluated as a stand-alone innovation, meaning it’s almost impossible to take any shortcuts through legacy exemptions. Such exacting demands are a direct representation of the more scrutinous reality that IVDR hopes to create.
This level of scrutiny is supremely evident in the reclassification of IVD risk categories. IVDR has nearly 5x the articles of IVDD, and most of this extension is due to Europe’s completely overhauled approach to risk classification. IVDD’s broader categorizations are now replaced by a detailed rule set designed to encompass every IVD innovation:
CLASS A
Covers most laboratory devices (e.g., specimen receptacles)
CLASS B
Covers IVDs with lower risk, including most devices that do not fall into another classification (e.g., cholesterol self-test)
CLASS C
Covers many high-risk IVDs that likely do not affect the wider population (e.g., blood glucose self-test)
CLASS D
Covers devices that detect the presence of, or exposure to, a transmissible agent (e.g., HIV blood diagnostic test)
This new rule set, outlined in Annex VIII of the IVDR, is based on a unique device’s risk and intended purpose with class D being the highest risk class and requiring the most stringent documentation. Consequently, the only guidance available comes from those experts at the forefront of their specialization.
For a more in-depth analysis of the latest IVDR risk reclassifications and actionable steps for your organization, consult our white paper.
IVDR Pre-Market Considerations
Pre-market documentation is a perfect example of how IVDR takes a much more detailed approach to regulation. IVDD included only the vaguest requirements for pre-market plans and reports, while IVDR requires a performance evaluation plan (PEP) and performance evaluation report (PER), both of which are outlined at length in Annex XIII, Part A of the IVDR.
The PEP is intended to present data that demonstrate an IVD’s safety and efficacy in three main areas:
SCIENTIFIC VALIDITY
Association of an analyte with a clinical condition or a physiological state
ANALYTICAL PERFORMANCE
Ability of a device to correctly detect or measure a particular analyte
CLINICAL PERFORMANCE
Ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user
By checking the availability of pre-market clinical data, the PEP can be an empowering document that supports the development of the PER and serves as the foundation for conformité européenne (CE) marking under the IVDR.
The PER is similar to the clinical evaluation report (CER) for a medical device, except that it focuses more on misdiagnosis rather than safety events caused by the device itself, as the greatest risk with IVDs is user error and the resulting consequences of an incorrect diagnosis.
We go into further specifics on the ins and outs of PEPs and PERs as well as what you need to do about them in our white paper.
IVDR Post-Market Consideration
IVDR increases post-market surveillance demands considerably, especially for IVDs classified as high-risk. In Articles 78-81, IVDR clearly expresses its new post-market requirements, including expected documentation for each process as defined by their risk classification:
POST-MARKET SURVEILLANCE
(PMS) PLAN
Describes the collection and utilization of available post-market information
POST-MARKET
SURVEILLANCE REPORT
Presents the results and conclusions of the data gathered according to the PMS plan with a rationale for any preventative or corrective actions taken
(Only required for class A and class B IVDs; updated every 5 years)
PERIODIC SAFETY UPDATE
REPORT (PSUR)
Presents the results and conclusions of the data gathered according to the PMS plan
(Only required for class C and class D IVDs; updated annually)
Excluding those in class A, most IVDs will also require a post-market performance follow-up (PMPF) plan. Though a PMPF plan is usually included in a PMS strategy for CE-marked devices, it is now considered an essential part of post-market considerations under the IVDR, a concept we explore further in our white paper.
Why IVDR Planning Takes Avania
It’s not enough to simply understand IVDR’s standards and how they’re different from IVDD — you must also take proactive steps to mitigate its effects on your pre-market and post-market procedures for data capture and documentation, as well as CE marking.
Such action necessitates insight from forward-thinking industry leaders. The Avania team boasts vast experience with in vitro device regulation — an experience that could become your product’s competitive edge as it navigates new requirements to get to market. When you need to comply with ever-changing regulations, It Takes Avania.