What This Page Covers
We support IVD and CDx manufacturers across the lifecycle, from classification and performance evaluation to Notified Body submission and post-market surveillance, covering EU IVDR, UKCA, FDA, and global markets via regulanet®.
This page covers in vitro diagnostic medical devices regulated under EU IVDR 2017/746, including reagent kits, companion diagnostics (CDx), instruments, standalone diagnostic software, and sample containers / specimen receptacles. For medical devices that are not IVDs, see Medical Devices. For standalone software as a medical device (SaMD) and AI-enabled diagnostics, see Digital Health & SaMD. For drug-device combination products where the primary mode of action is the drug, see Combination Products.
Visitors who previously worked with CE plus will find the same teams and expertise here. CE plus has been fully integrated into regenold, and all device, IVD, and software capabilities continue under the regenold brand.
What Changed with IVDR
The shift from IVDD to IVDR was more disruptive for IVD manufacturers than MDR was for device manufacturers. Three areas changed fundamentally.
Classification and the Role of Notified Bodies
The shift from IVDD to IVDR was more disruptive for IVD manufacturers than MDR was for device manufacturers. Under the Directive, at least 80% of IVDs were subject to so-called self-certification, i.e. without involvement of an external regulator. Under IVDR, the new risk-based classification system (Classes A through D, based on IVDR Annex VIII) pushes the vast majority of products into classes that require Notified Body assessment (conformity assessment procedure). Manufacturers who have never worked with a Notified Body are now doing so for the first time which significantly changes the extent and quality of expected data and documentation as well as maturity of the quality management system.
Performance Evaluation
Performance evaluation includes a structured demonstration of scientific validity, analytical performance, and clinical performance. The depth of evidence required depends on the risk class, but IVDR expects more than the IVDD ever did, particularly for higher-risk devices. Common Specifications (CS) published by the Commission set minimum performance requirements for certain high-risk IVDs (e.g., HIV, hepatitis, blood grouping). Where CS exist, manufacturers must meet them or justify deviations. Where CS do not exist, it is up to the manufacturer to find the sweet-spot between too little (resulting in delays during the certification procedure) and too much (resulting in significant unnecessary costs and time).
Post-Market Obligations
PMS and PMPF (Post-Market Performance Follow-up) requirements as well as vigilance reporting obligations all apply from the IVDR date of application (May 2022), regardless of whether the product has transitioned yet. Many IVD manufacturers, particularly smaller ones, did not have sufficiently mature PMS and vigilance processes or failed to update them to IVDR requirements
IVDR Transition Deadlines
The transition operates on staggered deadlines tied to risk class.
Class D
Dec 2027
Highest risk (HIV, hepatitis, blood grouping). NB application by May 2025. Written agreement by Sep 2025.
Class C
Dec 2028
Tumour markers, certain infectious disease tests, CDx. NB application by May 2026. Written agreement by Sep 2026.
Class B & A Sterile
Dec 2029
NB application by May 2027. Written agreement by Sep 2027.
Class A Non-Sterile
May 2022
Full IVDR compliance required since May 2022. No transitional provisions.
All legacy devices must maintain IVDD compliance, have no significant changes to design or intended purpose, and the manufacturer must have an IVDR-compliant QMS in place. For products not yet CE marked, the only option is certification under IVDR.
Companion Diagnostics Under IVDR
CDx sit in a unique regulatory position because they straddle two worlds: IVD regulation and medicinal product regulation. Under IVDR, a companion diagnostic is defined as a device essential for the safe and effective use of a corresponding medicinal product (Article 2(7)). CDx are classified as Class C, which means Notified Body involvement is mandatory.
The critical procedural difference for CDx: before issuing a certificate, the Notified Body must consult EMA (or a national competent authority for medicinal products depending on who is involved in the approval process of the medicinal product) on the suitability of the CDx for use with the corresponding medicine. This both increases regulatory complexity and adds challenges related to aligning both the medicinal product’s clinical development with the corresponding companion diagnostic.
Three development scenarios for CDx in the EU:
Scenario 1: Co-Development with a New Drug
The CDx and the drug are developed in parallel, often using the same clinical trial population. This is the cleanest scenario but requires tight coordination between the pharma and diagnostic sponsors, and between their respective regulatory tracks (EMA for the drug, Notified Body + EMA consultation for the CDx).
Misalignment between the two timelines is the most common source of delay. Industry data suggests six to twelve months of delay is typical when drug and CDx development are not integrated from the outset.
Scenario 2: Follow-On CDx for an Approved Drug
A new test targeting the same biomarker as an existing CDx, often offering a different technology platform (e.g., NGS vs. IHC). The CDx manufacturer must demonstrate analytical and clinical performance for the specific intended use, and the Notified Body still consults EMA.
The key challenge is defining appropriate bridging strategies and accessing clinical samples and data linking test results to clinical outcomes.
Scenario 3: Legacy CDx Transitioning from IVDD
Devices CE-marked under IVDD that need to be reassessed under IVDR. This often requires additional performance data, updated technical documentation, and a full Notified Body conformity assessment for the first time. The transition deadlines for Class C apply.
We have both IVD and pharmaceutical regulatory expertise in-house, which matters for CDx because the drug-diagnostic interface requires understanding both frameworks simultaneously. We manage the IVD technical documentation and conformity assessment procedure while coordinating with the pharma regulatory track to keep timelines aligned.
IVDs in Drug Clinical Trials
The CTR-IVDR Interface
When an IVD is used in a drug clinical trial to make treatment decisions (e.g. patient selection, dose selection, safety monitoring), it may trigger IVDR requirements even if the device is not the subject of the trial (see MDCG guidance 2022-10). This is one of the most frequently underestimated regulatory questions in drug development programmes that involve diagnostic testing. The answer depends on the specific scenario, and in general, three pathway options exist: a clinical performance study (CPS) running in parallel to the drug clinical trial, an in-house test under IVDR Article 5(5), and use of a commercially available CE-marked assay with an appropriate intended purpose. Each carries different regulatory, cost, and timeline implications.
For details on how we support CTR-IVDR interface projects, see Medical Device & IVD Regulatory Services.
Applicable Services Across the Development Journey
Select a phase to see what is needed for IVDs and companion diagnostics at that stage.
Discovery & Concept
Classification under IVDR Annex VIII. Intended purpose definition (analytes, specimen types, target population, target claims). Design control setup. For CDx: early alignment with the pharma partner on biomarker strategy and co-development timeline. Identification of applicable Common Specifications. Regulatory pathway mapping: Notified Body involvement required for Class B, C, D.
Preclinical
Analytical performance evaluation strategy and study designs (sensitivity, specificity, precision, limit of detection, interfering substances). Reference material sourcing. For CDx: analytical validation plan aligned to the biomarker and intended clinical use. Risk management file initiation (ISO 14971). Formative usability testing integration (IEC 62366-1). If software is a component: software lifecycle per IEC 62304.
Design & Development
Technical documentation per IVDR Annex II/III. Design control principles applied. Performance evaluation plan covering scientific validity, analytical performance, and clinical performance. Execution of analytical performance studies. QMS implementation or gap assessment against ISO 13485 and IVDR. For CDx: coordination with the pharma sponsor on clinical trial protocol and sample access. UDI implementation planning.
Clinical
Clinical performance studies where required (IVDR Annex XIII/XIV). For CDx: the clinical performance evidence is often generated within the drug’s clinical trial. Performance study applications to competent authorities (IVDR Article 58). For self-testing devices and near-patient testing: study designs considering related characteristics and involvement of lay-persons.
Regulatory Submission & Approval
Conformity assessment application to Notified Body (Class B, C, D). For CDx: EMA or NCA consultation triggered by the Notified Body (IVDR Article 48). Technical documentation including performance evaluation report, risk management file, GSPR mapping.
Launch & Market Access
EUDAMED registration. UDI implementation. Labelling and IFU compliance. Management of economic operator relations (distributors, importers). For CDx: alignment of diagnostic and drug labelling. Authorised representative appointment for non-EU manufacturers.
Post-Market & Lifecycle Management
PMS and PMPF (Post-Market Performance Follow-up). PSURs for Class C and D (annual submission to Notified Body). Vigilance reporting. For CDx: monitoring of changes to the corresponding drug's SmPC or indication that may affect the diagnostic's intended purpose. Device modifications assessed against IVDR significant change criteria.
Example Projects
Complementary Diagnostic Immunoassay: EU + US Dual Submission
End-to-end development support combining EU and US requirements to ensure CE marking and 510(k) readiness. Lean analytical and clinical study designs to minimise operational burden and costs whilst matching regulatory requirements. Compilation of the Technical Documentation and 510(k) file. Successful pre-alignments with FDA and Notified Body on all critical project milestones.
Multiple Companion Diagnostics: Co-Development and Bridging
Successful implementation of both co-development and bridging strategies for multiple CDx candidates covering different indications and technologies. Implementation of measures to enable use of the CDx candidate in key drug clinical studies across multiple EU countries and the US whilst minimising the number of testing sites.
Large IVD Portfolio: IVDR Transition Strategy
Strategy development for transition of a large assay portfolio to IVDR, maximising benefits of the sampling approach whilst minimising risks through staged transition. Optimising intended purposes to match existing performance data whilst preserving product value. Targeted gap assessments on representative products to allow systematic remediation at portfolio level. QMS strengthened to match IVDR requirements including outsourced process controls.
Developing or Certifying an IVD or Companion Diagnostic?
Tell us about your product, its classification, and your target markets. We will assess the regulatory pathway and outline how we can support.
Speak with an ExpertFrequently Asked Questions (FAQ)
How does IVDR classification differ from the old IVDD system?
Completely. IVDD used a list-based system (List A, List B, self-testing, Annex II). IVDR uses seven classification rules across four risk classes (A through D) based on the device's intended purpose, the risk to the individual patient, and the risk to public health. Many devices that were self-declared under IVDD now require Notified Body involvement. Classification should be reassessed from scratch against IVDR Annex VIII.
What is the EMA consultation for companion diagnostics?
Under IVDR Article 48, the Notified Body must request a scientific opinion from EMA (or a designated national medicines authority) on whether the CDx is suitable for use with the corresponding medicinal product. EMA assesses the scientific validity and the analytical and clinical performance in relation to the drug. The nominal timeline is 60 days, extendable by another 60. This is a mandatory step that does not exist for standard IVDs.
What are Common Specifications and when do they apply?
Common Specifications are published by the European Commission and set minimum requirements for certain categories of high-risk IVDs, particularly those previously on List A and List B (e.g., HIV, hepatitis B/C, blood grouping reagents). Where CS exist, manufacturers must demonstrate compliance or provide a scientifically justified deviation.
Can we use clinical data from the drug trial for our CDx performance evaluation?
Yes, and for co-developed CDx this is standard practice. The clinical performance of the CDx is typically demonstrated using samples and outcomes from the drug's clinical programme. The challenge is ensuring that the performance study is designed into the drug trial protocol from the start, with appropriate sample collection, storage, and testing procedures defined in advance. Retrofitting CDx performance evaluation onto an already-running drug trial is possible but creates data quality and logistical complications.
How tight is Notified Body capacity for IVDR?
Even though the situation has improved, lead times for conformity assessment can still be significant, particularly for Class C and D devices. New bottlenecks are expected as transitional deadlines approach. Early engagement and a complete, high-quality submission package are the most effective ways to reduce delays.
Do we need separate submissions for EU and US?
Yes. The EU follows IVDR with Notified Body conformity assessment. The US follows FDA pathways: most CDx have historically required PMA (Class III), though FDA has recently proposed reclassifying certain oncology NAAT/NGS CDx to Class II (510(k) pathway), which would significantly reduce the regulatory burden for those product types. We coordinate parallel EU and US submissions to maximise data reuse and minimise timeline gaps.