Achieve EU market access for in vitro diagnostic medical devices.
Achieve EU market access for in vitro diagnostic medical devices.
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.
Download the IVDR Service Description
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.
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Regulation |
Key Provisions |
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(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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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:
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:
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.
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.
Application & Onboarding
Topics of manufacturer
Conformity Assessment Procedure
Existing clients with TÜV SÜD Notified Body:
Potential clients with IVDR Transition Timeline:
Get Started with TÜV SÜD
Request our services for your IVDR needs. Start your journey with us. Request a reachout
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.
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:
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Service |
Rate |
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Audit and QM System Assessment Services |
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Audit |
320 € per hour |
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Assessment of Change Notifications and Extensions for Quality Safety Systems, IVDR |
320 € per hour |
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Technical Documentation Assessment Service |
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Technical Documentation Assessment Offsite |
430 € per hour |
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Clinical Assessment |
430 € per hour |
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Application Management Fee |
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Per case |
2,550 € |
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Initial Assessment of Vigilance Information |
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Each case count 1-200 |
400 € |
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Each case count > 200 |
80 € |
Ensure a smooth process of complying with the IVDR with the following resources.
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Audit Checklists |
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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.
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IVDR Technical Documentation Submission Requirements This checklist will help you prepare the technical documentation for submission to the notified body. |
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Certification Guidance Documents |
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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.
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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. |
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Additional Infosheets |
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The European In Vitro Diagnostic Medical Device Regulation (IVDR) This infosheet provides an overview of the IVDR and what you need to do.
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IVDR Class D This infosheet provides information on the provisions for special scrutiny of high-risk Class D devices.
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IVDR Classification This infosheet provides information on medical device classification under the IVDR (EU) 2017/746. |
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Learn Technical Documentation submission requirements.
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Get an overview of IVDR sampling for Class B and C devices' technical documentation.
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Learn about IVDR CDx certification and the consultation process.
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Discover the European Regulation on in vitro diagnostic medical devices (EU) 2017/746 (IVDR) with provisions for special scrutiny of high-risk Class D devices.
Learn More
Learn about extension of the IVDR Transition Period Under Regulation (EU) 2024/1860.
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Learn about the IVDR and its device classification.
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Learn IVDR risk-based classification for medical devices.
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