The EU In Vitro Diagnostic Regulation (IVDR) formally known as Regulation (EU) 2017/746
replaces the former In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC) and
introduces a modernised framework for regulating in vitro diagnostic devices within the
European Union. For manufacturers around the world, understanding what the EU IVD
Regulation is has become of utmost importance. Full implementation of the regulation
introduces a rigorous, risk-based approach to conformity assessment, increased scrutiny of
clinical evidence, and new roles for economic operators. As a result, the transition from the
previous IVDD to the current EU In Vitro Diagnostic Regulation is not merely a compliance
exercise, but a fundamental change in how the European Union ensures the safety,
effectiveness and transparency of diagnostic tools.
What Is EU IVDR? Understanding the Regulation’s Scope and
Purpose
Officially applicable since 26 May 2022, the EU IVDR significantly raises the regulatory bar to
ensure better patient safety, device performance, and transparency across the entire lifecycle of
diagnostic products. But what is EU IVDR really about? At its core, IVDR introduces a risk-
based classification system, shifts the majority of conformity assessments under the purview of
Notified Bodies, and places more stringent requirements on clinical evidence, post-market
surveillance, and traceability. For the first time, all economic operators involved in placing IVDs
on the market including manufacturers, importers, distributors, and Authorised Representatives
are assigned specific obligations.
One of the regulation’s key aims is to foster greater patient and public health protection by
ensuring that all IVDs meet high standards of safety and effectiveness before and after entering
the EU market. It also enhances transparency through the EUDAMED database, where certain
public information about devices and their conformity can be accessed by users, healthcare
professionals, and regulators alike.
In comparison to the IVDD, under which only around 15% of IVDs required Notified Body
involvement, the in vitro diagnostic regulation EU mandates third-party assessment for
approximately 80–90% of IVDs. This major paradigm shift means that most manufacturers must
now reassess their products and documentation to remain in the European market.
Who Is Affected by the EU In Vitro Diagnostic Regulation?
The EU in vitro diagnostic regulation reshapes compliance expectations across the entire IVD
supply chain, affecting not only manufacturers but also importers, distributors, and Authorised
Representatives.
Manufacturers
Whether based in the EU or outside, manufacturers are primarily responsible for ensuring their
devices meet EU IVDR compliance. This includes classifying products under the new risk-
based rules, preparing comprehensive technical documentation, conducting performance
evaluations, and maintaining robust post-market surveillance systems. Importantly, non-EU
manufacturers must appoint an EU Authorised Representative, —such as Obelis, to act as
their liaison with EU authorities.
EU Authorised Representatives
Under the IVDR, Authorised Representatives bear increased regulatory accountability. They
must verify the availability of technical documentation, assess conformity declarations, and
terminate cooperation if a manufacturer fails to meet regulatory obligations. This elevates their
role from administrative intermediaries to active compliance monitors, highlighting the
importance of selecting an experienced and trusted regulatory partner.
Importers
Importers must ensure that the IVDs they place on the EU market are compliant with IVDR. This
includes verifying CE markings, checking that the EU Declaration of Conformity is present and
labelling compliance, and ensuring the manufacturer has appointed an Authorised
Representative. They are also required to register their details in the EUDAMED database, and
cooperate with authorities, manufacturers, and authorised representative in case of non-
conformities. Where the device presents a serious risk, they shall also immediately inform the
competent authorities of the Member States in which they made the device available and, if
applicable, the notified body that issued a certificate.
Distributors
Distributors now have a duty to check that products are correctly labelled, CE-marked, and
accompanied by the necessary information before placing them on the market. They must also
retain records of non-conformities and forward any user complaints to the manufacturer or
Authorised Representative.
Notified Bodies
Unlike under the IVDD, IVDR dramatically increases the number of devices requiring
assessment by Notified Bodies. However, a shortage of designated bodies has caused
regulatory bottlenecks, especially for high-risk Class D devices. Manufacturers must plan ahead
and engage with Notified Bodies early to secure timely certification.
Notified Bodies are third-part conformity assessment bodies. Their involvement is mandatory for
the vast majority of IVDs. Certification timelines can very depending on the preparedness of
documentation and risk class of devices. Manufacturers must plan ahead and engage with
Notified Bodies early to secure timely certification.
Risk-Based Classification: How IVDR Reclassifies IVDs
A cornerstone of the EU IVDR regulation is its transition from a list-based approach under the
IVDD to a risk-based classification system. This shift aligns IVD regulation more closely with
the principles already established under the MDR for medical devices and ensures that the level
of regulatory scrutiny corresponds directly to the risk a device poses to public and individual
health.
The Four New Risk Classes
Under IVDR, in vitro diagnostic devices are now categorised into four risk classes A, B, C, and
D based on intended use, impact on patients, and potential public health consequences:
● Class A: Low individual and public risk (e.g., laboratory equipment, specimen
receptacles).
● Class B: Moderate risk (e.g., pregnancy tests, fertility diagnostics).
● Class C: High individual risk and/or moderate public risk (e.g., self-testing with some
exceptions, devices used for blood grouping testing, screening, diagnosis, or staging of
cancer).
● Class D: High individual and high public risk (e.g., HIV or hepatitis testing, blood
grouping tests for transfusion).
This classification determines the conformity assessment route, the level of Notified Body
involvement, and the depth of technical documentation required.
Performance Evaluation and Clinical Evidence: The New
Standard
The regulation introduces a detailed framework for performance evaluation, placing stricter
demands on manufacturers to prove that their in vitro diagnostic devices are not only
scientifically sound but also clinically relevant and reliable.
Three Pillars of Performance Evaluation
IVDR outlines a robust performance evaluation model built on three pillars:
- Scientific Validity – Evidence that the analyte or marker targeted by the device is
scientifically associated with a physiological state or clinical condition. - Analytical Performance – Assessment of accuracy, sensitivity, specificity, repeatability,
and limits of detection under laboratory conditions. - Clinical Performance – Evidence that the device provides results correlating with the
intended clinical use in the target population and intended user.
Each of these pillars must be documented through appropriate studies and included in the
Performance Evaluation Plan (PEP) and the Performance Evaluation Report (PER), both
integral parts of the technical documentation.
The Performance Evaluation Plan (PEP)
The Performance Evaluation the performance evaluation begins with the establishment of the
Performance Evaluation Plan (PEP). Among others, this foundational document must outline:
the intended purpose of the device, intended user, target population, degree of innovation,
scientific validity, assay technology, state-of-the-art, risk to patient, disease state, device
classification, degree of variability of the study subject population, prevalence of the clinical
state, availability of certified reference materials or certified reference methods, stability of
specimens, reagents, etc., availability of common specifications. The requirements for the PEP
are set out in the IVDR Annex XIII.
The Performance Evaluation Report (PER)
The PER consolidates all performance data and presents a risk-benefit analysis based on data
collected. Generally, it must demonstrate that the device achieves its intended purpose,
maintains analytical and clinical performance over time, remains safe and effective under
defined conditions of use.
Post-Market Performance Follow-Up (PMPF)
PMPF is a ongoing activity under IVDR that verifies the continued performance and safety of
the IVD once it is on the market. In most of the cases, the PMPF is mandatory. However, PMPF
is not deemed appropriate for a specific IVD when a proper justification is provided and
documented. It may include: monitoring and analysis of data from post-market use, assessment
of published experience gained by routine diagnostic testing, involvement in external quality
control schemes, identification of new mutations, strains, or variants which may impact the
performance of the IVD, inputs from post-market surveillance, and from PMS studies.
How Obelis Supports IVDR Compliance for Global Manufacturers
The introduction of the EU IVDR regulation has redefined the landscape for in vitro diagnostic
devices in Europe. Today, market access is contingent upon robust clinical evidence, proactive
post-market surveillance, and full transparency across the device lifecycle. Understanding what
is EU IVDR, who it affects, and how to comply is critical not just for regulatory conformity, but for
ensuring the continued trust of clinicians, patients, and regulators.
This is where Obelis comes in. With over 30 years of experience supporting global
manufacturers, we act as your EU Authorised Representative and regulatory partner. Our team
doesn’t just help you tick boxes, we provide tailored, expert guidance to help you navigate IVDR
requirements with confidence. From classification strategy and technical documentation to
performance evaluation and post-market compliance, we support you every step of the way.
IVDR compliance may be complex, but it doesn’t have to be overwhelming. With Obelis, you
gain not only market access but peace of mind, knowing that your products meet the highest
regulatory standards in Europe.
Leave a Reply