Medical Device Market Approval & Certification

EU In Vitro Diagnostic Medical Device Regulation

Be confident of medical device market approval

Be confident of medical device market approval

UNDERSTANDING THE IN VITRO DIAGNOSTIC REGULATION (IVDR)

The IVDR is the current regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market.

 It 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 need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail.

Request for an IVDR Service Registration today

 

TRANSITION timeline

Under Regulation EU 2023/607, the ‘sell off’ dates in article 110(4) of the IVDR are removed. This allows in vitro diagnostic medical devices which are already placed on the market, to remain on the market without having to be disposed of. This can only be done if the devices were originally compliant to previous legal requirements under In Vitro Diagnostic Directive (IVDD).

The transition period depends on the class of the IVD device under the current Directive and Regulation 2017/746 as well as additional conditions available below in the next section:

  • Devices placed on the EU market prior to 26 May 2022 as self-declared (i.e. with no notified body involvement) and that require the involvement of a notified body under the Regulation, may be placed on the market or put into service under the Directive until the following dates:
    • 26 May 2026, for class D devices;
    • 26 May 2027, for class C devices;
    • 26 May 2028, for class B devices and class A devices placed on the market in sterile condition.
  • Devices placed on the EU market prior to 26 May 2022 with notified body certificate, may be placed on the market or put into service under the Directive until 26 May 2025.

See graph below for a summary of the timeline of Regulation 2022/112 on IVDR Transitional Provisions.

IVDR regulation timeline

The additional conditions are that no significant changes to the device design and intended purpose are done and the device continues to meet the requirement of the IVD Directive as per IVDR article 110(3).

However, some requirements of the IVDR (e.g. post-market surveillance, vigilance, registration of economical operators, market surveillance) will apply from IVDR DoA as per article 110 (3).

See below for a summary of conditions necessary to benefit from the transitional measures.

IVDR transitional measures

How can you prepare?

Although the IVDR Date of Application has passed, implementing and delegated acts as well as guidance documents are still being published. IVD device manufacturers are well-advised to stay current regarding the publication of these acts and guidance documents.

Since most IVD devices will now require Notified Body review and approval, potential delays in the review and approval process by Notified Body should be considered. Therefore, it is recommended that manufacturers consult with their respective Notified Body to evaluate potential issues related to currently approved devices and to develop a plan to address them promptly, and ensure a smooth transition to the IVDR requirements.

How can TÜV SÜD help you?

A. IVDR Request for Service Registration

As one of the world’s largest EU Notified Body for all types of medical devices covered by EU directives and regulations, TÜV SÜD Product Service is designated as a Notified Body under the IVDR. Under the regulations, stricter requirements are imposed on Notified Bodies and all existing Notified Bodies have to receive new notification. Therefore, it is essential for manufacturers to have a Notified Body who will retain their status under the regulation.

Request for an IVDR Service Registration today

B. CONFORMITY ASSESSMENT PROCEDURE

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 requirements of the new regulation and will need to be re-evaluated and re-approved.

As manufacturers need to apply for an applicable conformity assessment procedure based on their product classification; a step by step information guide on each of the procedures is provided here

C. Structured Dialogue

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 limited to meetings with clients before the application for a conformity assessment and are independent of the assessment. Therefore, and to show the utmost intention of being independent, impartial, and objective, the structured dialogue service shall be ordered independently from the IVDR framework agreement.

Expand the tabs below to find out the possible topics, process and how to apply for Structured Dialogue.

EXPLORE

medical devices

IVDR Request for Service Registration

Be confident of IVD medical device market approval

Learn More

EU IVDR
Ulotka

EU’s In Vitro Diagnostic Medical Device Regulation

A quick guide to the IVDR and what to expect

Learn More

Legacy Products Under IVDR
Ulotka

Legacy Devices under IVDR

Stay updated on the requirements for devices that were already on the market under IVDD and learn how to transition into IVDR.

Learn More

VIEW ALL RESOURCES

Jak możemy pomóc?

Wybierz lokalizację