EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR)

IVDR stands for a European regulation, the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. This regulation, with an application date of May 26, 2022, and which has been in force since 2017, deals with regulating the marketing and commissioning of medical devices for in vitro diagnosis throughout the territory of the European Union, as well as Northern Ireland after Brexit. This regulation repeals Directive 98/79/EC on medical devices for in vitro diagnostics.

The transition time for in vitro diagnostic medical devices (IVDs) to comply with the EU IVD regulation 2016/746 (IVDR) is coming to an end: IVDR will be fully implemented from May 26, 2022. The new in vitro diagnostic medical devices will be required to comply with the IVDR, while IVDs certified under the IVD directive 98/79/EC (IVDD) will not be valid as of May 27, 2024. Time passes quickly and it must be kept in mind that compliance with the IVDR requires much more work than the IVDD. QSG´s objective is to work together with you to be able to carry out this transition in an organized and planned manner, fulfilling the objectives of the Regulation.

One of the most significant changes introduced by the IVDR is the new classification for IVDs. The IVDR specifies a clear set of rules for classifying IVDs into four risk categories, ranging from Class A (lowest risk) to Class D (highest risk). Manufacturers must determine the IVD class regardless of how it was classified on the IVDD. Annex VIII of the IVDR provides the list of rules required for IVD classification.

It is important that manufacturers of this type of in vitro diagnostic medical device act with time and proper planning, because the new regulation introduces major changes and has a great impact on the industry. IVDR matches the requirements of the Medical Device Regulation (EU) 2017/745.

Key changes

As mentioned before, the IVDR seeks to achieve greater traceability and higher quality standards, together with an exhaustive performance evaluation report. Some of the main points of changes introduced are mentioned below:

  • New criteria and requirements in the designation and supervision processes of Notified Bodies have been crucial for the correct compliance of all diagnostic and invitro devices.
  • Exponential increase in documentation requirements: of the general quality system (Quality Management System-QMS) based on ISO 13485; of technical documentation, with greater risk requirements (ISO 14971), and performance evaluation documentation (scientific, analytical, and clinical validity).
  • The IVDR includes more types of devices, such as diagnostic services, genetic tests, companion diagnostics, and software.
  • New definitions introduced in the IVDR include “point-of-care diagnostic tests” and “diagnostic tests for therapeutic selection”. It also regulates testing services offered over the Internet.
  • Strong change in the classification of products are classified based on risk, and from two lists (A, B) and the rest that were self-certified, we went on to Classes: A, B, C and D. A indicates the least risk and that does not require a Notified Body.
  • Greater control of higher risk products. Class D devices need to pass analysis by a reference laboratory designated by the commission and class C – Companion Diagnostics (Therapeutic selection diagnostic tests) will have to consult with the competent authorities.
  • Greater traceability requirements with the obligation to assign a UDI (Basic UDI-DI, UDI-DI, UDI-PI), and in conjunction with the EUDAMED European database.

EU IVDR Timelines

General

  • 26th May 2022: Date of application of the EU IVDR.
  • 26th May 2025: certificates issued under IVDD become void.
  • IVDs that are self-certified or self-assessed under the IVDD but will require certification by a notified body will have the following due dates:
    • May 26, 2022 for Class A: May 26, 2025
    • May 26, 2025for Class D: May 26, 2026
    • May 26, 2026for Class C: May 26, 2027
    • May 26, 2027for Class B: May 26, 2028
    • May 26, 2027for Class A sterile: May 26, 2028
  • The applicability of most requirements for health institutions performing in-house manufacturing would be postponed until May 26, 2024, except the ones exempt, which is postponed until May 26, 2028.

Technical file structure

Download the Technical File Structure  to comply with the new IVDR for free!

Most common questions about EU Medical Device Regulations

WHAT IS THE “SELL-OFF” PROVISION ABOUT?
The “sell-off” provision is intended to limit the time during which devices that are compliant with the Directive and have already been placed on the market may be made available. Any device that is still within the supply chain and has not reached its end user as ready to use can no longer be used.

ARE PRODUCTS THAT COMPLY WITH THE REGULATION AND THAT ARE PLACED ON THE MARKET SUBJECT TO THE SO-CALLED “SELL OFF” PROVISION OF ARTICLE 110 SECTION 4 OF THE IVDR?
No, the possibility that they continue to be marketed or put into service is not limited in time.

DOES THE IVDR REQUIRE A CLINICAL EVALUATION REPORT?
No, the Clinical Evaluation Report is mandatory only for the MDR. In the case of the IVDR, the Performance Evaluation Report (PER) is a result of the process of performance evaluation activities. PERs for Class C and D devices must be updated at least once a year, while PERs for Class A and B devices must be updated as needed. The recommendation of the notifying bodies is to carry out a review at least every three years.

UNDER THE NEW IVDR, CAN MY DEVICE BE RE CLASSIFIED?
Yes, under the new IVDR every manufacturer must check if their device is still under the same classification or if anything has changed. QSG can support you preparing an EU Regulatory strategy document with your device classification. Also, we have the expertise on guiding you in order to have the device document in compliance with the new Regulation.

WHAT IS THE EUDAMED? AND THE UDI?
EUDAMED is the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on medical device for in vitro diagnostics and developed by the European Commission. The objective of this database is to provide the traceability for each medical device, and to facilitate the flow of information between all the actors (medical devices manufacturers, authorized representatives, importers, distributors, Notified Bodies, EU member states and the European Commission). EUDAMED’s major achievement is the registration of products with a unique UDI (Unique Device Identification).

WHEN DO MEDICAL DEVICE MANUFACTURERS NEED TO COMPLY WITH THE REQUIREMENTS OF THE NEW IVDR?
As of May 26, 2022, manufacturers and new products already had to comply with the new IVDR requirements to be marketed in the European Union. Also, is important to check frequently for due date updates, or contact expert consultants for new potential delays in the implementation.

HOW CAN MANUFACTURERS PREPARE FOR THE NEW IVDR?
To successfully transition from IVDD to IVDR, manufacturers must have a comprehensive and detailed management plan. Quality and Regulatory aspects must be considered, depending on the device classification. It is key for specialized third-party auditors to conduct internal audits in order to have an overview of the quality system and ensure compliance with the IVDR. A GAP analysis to evaluate needs for technical documentation is also a fundamental step.

Steps to go to the market when you have your device under MDD/IVDD

  1. TECHNICAL DOCUMENTATION UPDATE
    Perform a GAP analysis to know the status of the Technical Documentation.
    With this we will be able to evaluate what information is missing to comply with the requirements of the new Regulation. This also includes the Clinical Evaluation (MDR) or Performance Evaluation (IVDR), labeling, marketing material, and all the documents related to Post-Marketing Surveillance.
  1. QMS UPDATE
    Carry out an internal audit with an external auditor to evaluate the status of the Quality Management System (QMS). It is important to comply with ISO 13485 but also with the internal requirements of the Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, which exceed ISO 13485.
  1. OBTAIN THE CE MARK
    If it is necessary for the Notified Body to issue the CE mark, this is the time to submit the documentation.
    Note: It is important to keep in mind that there is a delay in the evaluations of the notified bodies. The sooner the appointment can be obtained the better it will be. Likewise, it is necessary to evaluate the time it will take to remedy the technical documentation and have the quality system in accordance with the new regulation.
    In the case a of self-certified device, the manufacturer must issue the Declaration of Conformity in compliance with the Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
  1. AUTHORIZED REPRESENTATIVE, IF NEEDED
    If the manufacturer is not EU based, it will be mandatory to contact an EU Authorized Representative.
  1. MAKE THE REGISTRATION
    Once the CE marking is obtained, it must be registered with EUDAMED and in the database of a member country. In the case of an EU based manufacturer, it is carried out by the same manufacturer. If the manufacturer is non-EU based, it must be done by the EU Authorized Representative.
  1. GO TO THE MARKET
    QSG will support you in every step for having your device on the market in compliance with the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).

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