EU IVDR Explained: Classification, Compliance, and Timelines for In Vitro Diagnostics

For manufacturers and distributors of diagnostic products in the EU, it is essential to comply with the In Vitro Diagnostic Medical Devices Regulation, Regulation (EU) 2017/746 (IVDR).

IVDR sets the rules for the regulation, documentation, labeling, and post-market monitoring of In Vitro Diagnostic (IVD) devices. The IVDR covers all kinds of tests conducted using samples taken from the human body such as blood, urine, swabs, among others including reagents, calibrators, controls, instruments, software, and complete systems.

Why the Shift from IVDD to IVDR Was Necessary

Before the IVDR became applicable on 26 May 2022, most of the manufacturers were bound by the provisions of Directive 98/79/EC (IVDD). Prior to the new directive, it was estimated that 80-90 percent of all IVDs in Europe were brought into the market through self declaration without the involvement of a Notified Body.

In contrast, IVDR has made several changes to this structure. In the new system, most of the IVDs need to go through the conformity assessment by a Notified Body.

Risk Classes Under Regulation (EU) 2017/746

IVDR Annex VIII has formulated a classification rule-based system which separates medical devices into four specific risk classes (A through D) taking into account their intended use, clinical effects, and the type of user.

Risk Class	Risk Profile	Typical Device Examples	Conformity Assessment Route
Class A	Lowest (individual and public)	Sample containers, washing buffers, laboratory reagents	Self certification (Notified Body required only if supplied sterile)
Class B	Moderate individual / low public	Pregnancy and fertility self tests, cholesterol assays, urine glucose strips (Rule 4(a) exceptions)	Notified Body assessment
Class C	High individual / moderate public	Companion diagnostics, genetic testing, cancer markers, most self tests	Notified Body assessment
Class D	Highest (individual and public)	HIV and hepatitis screening, high risk blood grouping reagents (ABO/Rh)	Notified Body assessment plus EU Reference Laboratory verification (where designated)

Rule 4(a) Exception: Under Annex VIII, self-testing devices default to Class C, with specific exceptions such as tests for pregnancy, fertility, cholesterol, glucose, and urine analytes (including erythrocytes, leukocytes, or bacteria) which are categorized under Class B.

Core Pillars of IVDR Compliance

1. Quality Management System (QMS) and Technical Documentation

There will be a need for the manufacturers to have a Quality Management System that is in line with the IVDR for all stages of production including the procurement, design, batch release, and post market surveillance. The ISO 13485 is normally used as the starting point of most quality management systems. The technical files should show adherence to GSPR and clinical validation.

2. Performance Evaluation

In IVDR regulations, the concept of performance evaluation comprises a continuous process involving three interrelated aspects:

Scientific validity: establishing scientific evidence about the clinical relation between analyte and disease.
Analytical performance: establishing the sensitivity, specificity, accuracy, precision, and cross-reactivity of the device.
Clinical performance: establishing the device delivers clinically significant outcomes as per its stated purpose.

3. Labeling, Economic Operators, and EUDAMED

Person Responsible for Regulatory Compliance (PRRC) and EU Authorised Representative (EU REP): It is compulsory for each manufacturer to designate a Person Responsible for Regulatory Compliance (PRRC). Moreover, it is compulsory for non-EU manufacturers to designate an EU Authorised Representative (EC REP).

Traceability: Medical devices are supposed to incorporate the Unique Device Identifiers (UDI) and register fully in EUDAMED modules.

Updated Transition Timelines (Regulation (EU) 2024/1860)

In order to avoid supply shortages, Regulation (EU) 2024/1860 amended the IVDR transitional provisions for legacy devices that have been assessed according to the previous directive. Extension of these periods is subject to certain regulatory requirements.

QMS baseline requirements: In order to make use of this extension period, manufacturers of all risk classes were expected to implement an IVDR compliant QMS system until 26 May 2025. The QMS date is not phased by risk class.

Class specific final deadlines and milestones:

Class D medical devices: deadline for final placing on the market is 31 December 2027. Formal application by the Notified Body was due on 26 May 2025, while the signed written agreement deadline is 26 September 2025.
Class C medical devices: deadline for final placing on the market is 31 December 2028. Formal application by the Notified Body was due on 26 May 2026, while the signed written agreement deadline is 26 September 2026.
Class B and Class A sterile medical devices: deadline for final placing on the market is 31 December 2029. Formal application by the Notified Body is due on 26 May 2027, while the signed written agreement deadline is 26 September 2027.

Please note that these transitional routes will be applicable only to legacy devices, which have not undergone any changes in terms of their designs and purposes. Non-sterile products falling into Class A category are not included in this transition period.

Navigating IVDR Compliance Challenges

The manufacturers have to deal with such regulatory issues as unanticipated medical devices up-classification, the need for additional performance data, and limited capacity of Notified Bodies. The key success factors will include Annex VIII risk classification from the early stages, technical file analysis, and planning of post-market activities.

Partner with Morulaa Healthtech for EU Market Access

IVDR compliance is a challenge that needs to be carefully strategized and executed. Whether you need help in technical documentation preparation, Quality Management Systems compliance, EUDAMED registration, or services of an Authorized Representative, Morulaa Healthtech will help your medical devices or In Vitro Diagnostic devices meet EU compliance. For more information, visit our website.