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What is the in vitro diagnostic regulation (IVDR)?
The In Vitro Diagnostic Regulation (IVDR) is the current European Union (EU) regulatory legislation for placing in-vitro diagnostic devices on the EU market, making them available and putting them into service.
The IVDR regulation was published in the Official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017, gradually replacing the EU’s former Directive on in vitro diagnostic medical devices (98/79/EC).
As a European regulation, it is effective in all EU member states and EFTA states immediately without needing to be transposed into the law of respective states. However, national laws may be adapted to back up some requirements in more detail.
Key IVD 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
|
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(EU) 2023/503 |
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(EU) 2023/607 |
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(EU) 2024/1860 |
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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
You must apply to the Notified Body (NB) by the dates listed below. You must then sign a contract with an NB by 26th September of the respective years. Your products can then continue to be placed on the market until the end of the transition period, as indicated below, depending on the Class of your devices.
For all legacy devices, certain requirements of the IVDR regulation, including post-market surveillance, vigilance, registration of economic operators, and market surveillance are applicable since the date of application of the IVDR (May 26, 2022) as per article 110 (3).
See the infographic below for a summary of the timeline of IVDR Transitional Provisions:
How you can prepare
- Ensure that your quality management system complies with the requirements of IVDR Article 10(8)
- Prepare your technical documentation in accordance with IVDR Annex II & III
- Assess whether existing information (e.g. from IVDD or ex-EU applications) is adequate to demonstrate compliance
- Generate required data to address any gaps
- Refer to our best practice guide for IVDR technical documentation
- Engage with us early on to discuss your needs
- Our Structured Dialogue provides an opportunity to discuss the procedural and regulatory requirements with us before lodging your application for IVDR conformity assessment
- Keep informed about new regulations and guidance
- Subscribe to our TÜV SÜD - Healthcare & Medical Devices LinkedIn channel
How TÜV SÜD can help you with the IVDR
As one of the world’s largest EU Notified Bodies for all types of medical devices covered by EU directives and regulations, TÜV SÜD is designated as a full-scope Notified Body under the IVDR regulation.
Our experts’ experience and expertise make TÜV SÜD your trusted service provider for the certifications required to place your in-vitro diagnostic devices to the EU market, providing a full range of certification and testing services for global market access.
We work collaboratively with our partners to ensure access to critical innovative diagnostic technologies for patients and providers.
Our experts’ experience and expertise make TÜV SÜD your trusted service provider for the certifications required to place your in-vitro diagnostic devices to the EU market, providing a full range of certification and testing services for global market access.
We work collaboratively with our partners to ensure access to critical innovative diagnostic technologies for patients and providers.
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 with TÜV SÜD 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 us before the application for a conformity assessment and are independent of the assessment.
Expand the tabs below to find out the possible topics, process and how to apply for Structured Dialogue.
FAQs
Possible topics for structured dialogue
Application & Onboarding
- Onboarding process
- Application forms & review process
- Sites, suppliers & devices
- Device classification & code assignment
Topics of manufacturer
- TÜV SÜD Testing & Certification Regulations
- IVDR Framework Agreement
- Handling of device and other changes
- Transfer to TÜV SÜD Notified Body
Conformity Assessment Procedure
- Project planning, time limits special procedures (e.g. consultation)
- Submission requirements
- Costs, fees & other financial aspects
- CS, guidance documents & harmonised standards
Structured dialogue process
How can I apply for structured dialogue?
Existing clients with TÜV SÜD Notified Body:
- If you are an existing client, please get in touch with your dedicated client manager to move forward
Potential clients with TÜV SÜD Notified Body:
- If you wish to engage TÜV SÜD as a Notified Body and kickstart the Structured Dialogue, please request a reachout.
IVDR application procedure
Based on the product classification, the manufacturer must apply for an applicable conformity assessment procedure.
Contact us using our simple service request form to initiate your application process.
English and/or German are the only acceptable languages for the submission of documentation and any related correspondence.
Certification costs
The certification costs are based on hourly rates. They consider factors such as the size of company, number of sites, and number and complexity of devices. TÜV SÜD Product Service GmbH takes into account the interests of SMEs by basing its entire fee structure mainly on effort-related criteria rather than fixed steps, thus enabling SMEs in particular for a precise and individual cost calculation based on the effort involved in each individual case. The standard fees for the conformity assessment activities delivered by TÜV SÜD Product Service GmbH are as follows:
Services | Hourly Rate* |
|---|---|
Audit and QM System Assessment Services
Audit |
|
Technical Documentation Assessment Service
|
430 € |
Application Management Fee
|
2,550 € |
Initial Assessment of Vigilance Information
|
400 € |
*Depending on the location of the manufacturer and possibility to include local experts or auditors in the conformity assessment procedure, prices may vary, and fees may be invoiced in local currency. |
IVDR resources
Ensure a smooth process of complying with the IVDR with the following resources.
Audit checklists:
IVDR QM System Requirements
This checklist will help manufacturers and the audit team prepare for the audit and see where the requirements are fulfilled or described.
IVDR Technical Documentation Submission Requirements
This checklist will help you prepare the technical documentation for submission to the notified body.
Certification Guidance Documents:
Extended IVDR Transition timelines
Here’s a quick guide on the IVDR timelines.
IVDR Sampling
Understand how TÜV SÜD implements the requirements of sampling for Class B and Class C devices under the IVDR. Review additional practical explanations and implications.
Legacy Products under IVDR
Here’s 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)
Find out how you can successfully complete IVDR certification for CDx devices.
Additional Infosheets:
The European In Vitro Diagnostic Medical Device Regulation (IVDR)
This infosheet provides an overview of the IVDR and what you need to do.
Download it here
IVDR Class D
This infosheet provides information on the provisions for special scrutiny of high-risk Class D devices.
IVDR Classification
This infosheet provides information on medical device classification under the IVDR (EU) 2017/746
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