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As of May 26, 2022, the new European Union IVDR regulation regarding medical devices will enter into force, replacing the EU IVD Directive (IVDD) IVDR stands for IVitro Diagnostic Regulation. In vitro diagnostics can be described as used to identify illness by testing body samples like blood, tissue, or urine. These tests take place outside of the body. This new EU regulation aims to increase the safety and performance of these medical devices for both patients and users. Implementing this new regulation meant a lot of work including implementing many new procedures. You can find more information about IVDR, how it might affect you and how to be compliant.

Main differences between IVDD and IVDR

IVDR is approximately four times longer than the IVDD, which can also be seen in the image above. There are several points that every IVD manufacturer should be aware of: 

  • Only manufacturers of non-sterile Class A devices will be able to self-certify, meaning that anywhere from 80-90% of the medical devices will require CE certification by  a Notified Body.
  • There are more post-market surveillance requirements in IVDRand they are more rigorous than those in the IVDD.
  • Provisions for software are also included in  IVDR. Software as part of an IVD, software as a medical device (SaMD) and apps are all regulated under IVDR.

What does it mean for pathology professionals?

Under the IVDD, products used for Research Use Only (RUO) and Lab-Developed Tests (LDTs) were considered outside the scope of the directive. IVDR however also regulates LDTs. RUO products are still considered outside the scope of the IVDR, provided the product is used for research purposes only and not for the benefit of a specific patient. If they are placed on the market as IVD by the manufacturer, they come within the scope of the IVDR under LDTs.


IVDD
IVDR
Research Use Only (RUO)
Outside of scope
Outside of scope, unless
Lab-Developed Tests (LTDs)
Outside of scope
In-scope

This makes IVDR, to a certain extent, also applicable to entities using RUO products or creating LDTs in-house for diagnostic purposes. 

LDTs under IVDR 

Based on the guidance issued, the following products are as LDTs considered within the scope of IVDR:

  • An in-house developed and produced test
  • Tests that are labelled Research Use Only (RUO) but used for diagnostics
  • A CE-marked test to which adjustments are made (intended purpose, or protocols)

IVDR requirements on LTDs 

A developer of LDTs is considered a manufacturer of an IVD under IVDR, and specific requirements of the IVDR legislation apply to those health institutions. IVDR – Article 5(5) – defines the requirements that need to be fulfilled for these LDTs and the health institutions that create and use them to comply with IVDR.

In order for LDTs not to be considered IVDs all of the following requirements need to be met: 

  1. the LDTs are not transferred to another legal entity;
  2. manufacture and use of the LDTs occurs in a controlled manner, i.e. under control of a Quality Management System;
  3. the laboratory of the health institution is compliant with standard EN ISO 15189 or where applicable national provisions, including national provisions regarding accreditation;
  4. the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or not sufficiently with an existing device.
  5. the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, any modifications made, and use;
  6. the health institution draws up a declaration which it shall make publicly available, including:
    1. the name and address of the manufacturing health institution,
    2. the details necessary to identify the devices,
    3. a declaration that the devices meet the general safety and performance requirements of the IVDRincluding information on which requirements are not fully met with a reasoned justification therefore.

If any of the requirements above is not applicable or cannot be met, and the tests are used for diagnostics purposes on human tissue, the full responsibilities of the IVDR apply.
Sakura Finetek Europe is committed to empowering pathology professionals during this transition phase. At the moment IVDR requirements are integrated into our products and processes and everything we do is aimed at compliance in line with the regulation coming to effect on 26 May.

Products with a manufacturing date before 26 May 2022 have been produced under the IVDD. These products do not have to comply with IVDR regulations and will remain compliant under the IVDD with a corresponding declaration of conformity, also after the 26th of May 2022. No further action is required on these instruments. Products manufactured per 26 May 2022 are all IVDR compliant.

If you have any questions, please contact us at info@sakura.eu.
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