European Regulatory Framework
IVD Regulation in the EU - IVDR 2017/746
The European Union overhauled its diagnostic framework with the introduction of the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. It introduces stronger performance-evidence and conformity-assessment requirements. Qualifying legacy devices can still rely on conditional IVDD transition arrangements while moving to IVDR.
The IVDR Classification Paradigm Shift
Under the previous IVD Directive (IVDD), nearly 80% of diagnostic devices could be self-certified by the manufacturer. The implementation of IVDR has fundamentally reversed this statistic. Today, approximately 80% of all IVDs require conformity assessment by an independent Notified Body before they can be placed on the European market.
EU IVDR Classification Matrix
| Class | Risk Level | Examples | Assessment Pathway |
|---|---|---|---|
| Class A | Lowest risk | Lab equipment, general reagents | Self-declaration (unless sterile) |
| Class B | Moderate risk | Urine analysis, general serology tests | Notified Body mandatory |
| Class C | High individual risk | Cancer screening, companion diagnostics | Notified Body; CDx consultation where applicable |
| Class D | High public health risk | HIV, HBV, blood screening products | Notified Body; applicable EURL and Common Specifications requirements |
Core IVDR Requirements
Rigorous Performance Evaluation
Performance evaluation connects scientific validity, analytical performance and clinical performance. Assess whether existing evidence supports the exact intended purpose, then address gaps through an appropriate evidence plan.
GSPRs and Technical Files
Manufacturers must prove strict conformity to the General Safety and Performance Requirements (GSPRs) found in Annex I. This requires a comprehensive technical file containing design details, risk management, and labeling plans.
Designated PRRC
It is legally required to appoint a Person Responsible for Regulatory Compliance (PRRC) who possesses specific technical and regulatory qualifications to oversee continuous compliance.
PMPF and UDI Systems
Post-Market Performance Follow-up (PMPF) ensures proactive device monitoring post-launch. Assess UDI and EUDAMED requirements for the device and regulatory status; legacy-device identifiers and transitional obligations differ from those for IVDR devices.
EUDAMED Transition Timelines
The first four EUDAMED modules became mandatory on 28 May 2026. Assess the actor, device and certificate obligations that apply to your role, including the transition provisions for existing records. Check the European Commission EUDAMED overview.
- 28 May 2026:Mandatory use began for the first four modules. Confirm the applicable actor-registration and new-device obligations.
- 28 November 2026:Transition deadline for applicable existing device records. Check whether the device meets the conditions in the Commission transition guidance.
- 28 May 2027:Transition deadline for applicable pre-existing certificate records; confirm scope and responsibilities with the Notified Body.
Key Legislative Amendments
Four additional regulations have been enacted with the primary purpose of providing adequate time and resources to ensure continued availability of devices on the EU market:
| Regulation | Key Provisions |
|---|---|
| (EU) 2022/112 |
|
| (EU) 2023/503 |
|
| (EU) 2023/607 |
|
| (EU) 2024/1860 |
|
IVDR Transition Timeline
Only “legacy” devices meeting the following conditions can benefit from the IVDR transition timelines:
- a) those devices continue to comply with Directive 98/79/EC;
- b) there are no significant changes in the design and intended purpose;
- c) the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;
The transition period depends on the classification of the device and whether it was CE-marked under the IVDD by self-declaration or by certification with a Notified Body. The following timelines apply:
Devices with an IVDD certificate
- 26 May 2025 – Implement IVDR-compliant quality system
- 26 May 2025 – Apply to a notified body
- 26 September 2025 – Conclude a written agreement with a notified body
- 31 December 2027 – End of transition period
Class D devices
- 26 May 2025 – Implement IVDR-compliant quality system
- 26 May 2025 – Apply to a notified body
- 26 September 2025 – Conclude a written agreement with a notified body
- 31 December 2027 – End of transition period
Class C devices
- 26 May 2025 – Implement IVDR-compliant quality system
- 26 May 2026 – Apply to a notified body
- 26 September 2026 – Conclude a written agreement with a notified body
- 31 December 2028 – End of transition period
Class B devices
- 26 May 2025 – Implement IVDR-compliant quality system
- 26 May 2027 – Apply to a notified body
- 26 September 2027 – Conclude a written agreement with a notified body
- 31 December 2029 – End of transition period
Class A sterile devices
- 26 May 2025 – Implement IVDR-compliant quality system
- 26 May 2027 – Apply to a notified body
- 26 September 2027 – Conclude a written agreement with a notified body
- 31 December 2029 – End of transition period
Class A (non-sterile) devices
Transition period does not apply – full compliance required as of 26 May 2022.
Preparing for Certification
To ensure a smooth certification process, manufacturers should prioritize the following steps before applying to a Notified Body:
- Ensure your quality management system complies strictly with IVDR Article 10(8).
- Prepare robust technical documentation in accordance with IVDR Annexes II and III.
- Assess whether existing data (from IVDD or non-EU markets) is adequate to demonstrate compliance, and generate new data to address any gaps.
- Engage in structured dialogue early to clarify procedural aspects before formal submission.
Further IVDR Details & Procedures
Structured dialogue
The complex development process for most types of medical devices, combined with the need to address new regulatory requirements and obtain Notified Body approval, is likely to make the transition a complicated and time-consuming process for most device manufacturers. Further, previously approved devices are not exempt from the new regulation's requirements and will need to be re-evaluated and re-approved.
The purpose of a structured dialogue prior to lodging a formal IVDR application is to clarify the timing, procedural, and regulatory aspects of the application process and forms, and the submission documents. These structured dialogues are an opportunity to meet with the Notified Body before the application for a conformity assessment and are independent of the assessment.
Possible topics for structured dialogue include:
- Application & Onboarding: Onboarding process, application forms & review process, sites & suppliers, and device classification & code assignment.
- Topics of manufacturer: Testing & certification regulations, framework agreements, handling of device changes, and transferring to a Notified Body.
- Conformity Assessment Procedure: Project planning, time limits, special procedures (e.g. consultation), submission requirements, costs & fees, and harmonised standards.
IVDR application procedure
Based on the product classification, the manufacturer must apply for an applicable conformity assessment procedure.
Please note: Not all Notified Bodies provide conformity assessment services according to IVDR Annex X. At lodging of an application of IVDR Annex XI for class C and D devices, the manufacturer needs to provide a copy of the EU type-examination certificates issued by the notified body designated for conformity assessment activities related to the types of devices concerned.
Confirm accepted submission languages and correspondence arrangements directly with the selected Notified Body.
Certification costs
The certification costs are based on hourly rates. They consider factors such as the size of the company, number of sites, and number and complexity of devices. Major Notified Bodies typically base their fee structure mainly on effort-related criteria to enable a precise and individual cost calculation.
Request an itemised quote from the designated Notified Body for your actual scope. Compare application handling, QMS assessment, technical review, travel, surveillance and change-assessment charges using the same product and site assumptions.
IVDR resources
Ensure a smooth process of complying with the IVDR with key checklists and guidance resources:
- Audit Checklists: Prepare using the IVDR QM System Requirements and IVDR Technical Documentation Submission Requirements checklists.
- IVDR Sampling: Understand how Notified Bodies implement the requirements of sampling for Class B and Class C devices under the IVDR.
- Legacy Products under IVDR: Information on how products that are already on the market under the old In Vitro Diagnostic Directive (IVDD) can transition to IVDR.
- IVDR Companion Diagnostics (CDx): Guidance on successfully completing IVDR certification for CDx devices.
- IVDR Class D: Information on the provisions for special scrutiny of high-risk Class D devices.
- IVDR Classification: Information on medical device classification under the IVDR (EU) 2017/746.
Our IVDR Compliance Solutions
We help assess IVDR evidence gaps, coordinate Notified Body applications and maintain consistent EUDAMED records across the product lifecycle.
Notified Body Representation
We support you through the rigorous conformity assessments required by EU Notified Bodies for Class B, C, and D devices.
EUDAMED Registration
Assess applicable EUDAMED actor and device registration obligations, including the transition arrangements for devices already on the market.
Clinical Evidence & PMPF
Develop robust analytical and clinical performance reports, and establish proactive Post-Market Performance Follow-up (PMPF) plans.
Technical Documentation
Compile comprehensive technical files ensuring strict alignment with the General Safety and Performance Requirements (GSPRs) of Annex I.
Looking for Full European Union CE-MDR & IVDR Services?
Access our comprehensive European regulatory portal covering EU Authorized Representative (EC-REP), Notified Body technical file compilation, EUDAMED registration, IVDR gap assessments, and post-market performance follow-up (PMPF).