AST of bacteria

IVDR and EUCAST

The IVDR (EU regulation 2017/746 on in vitro diagnostic medical devices) was published in April 2017 and is closely aligned to the EU regulation on medical devices. EUCAST receives many queries on how this regulation affects EUCAST recommendations and guidance. After having consulted with relevant organisations and based on accessible sources (until 17 February 2023), EUCAST has concluded (EUCAST on IVDR is translated to French and German):

 

  1. IVDR is a regulation related to the manufacture, sales, distribution, and use of in vitro diagnostic products. It does not regulate specific methods or ways of working. EUCAST does not manufacture, sell, or distribute or otherwise make available, any material or products. EUCAST issues breakpoints and guidance on how to perform and quality control susceptibility testing but does not recommend the use of any named product.
  2. Organisations adhering to EUCAST recommendations for antimicrobial susceptibility testing will need to produce or procure products (broth, agar, antibiotic disks, gradient tests, devices and more), for which the regulation is relevant, but only to the same extent as this applies to all laboratory equipment, material, or products. For products manufactured by the user for in-house use only (individual laboratory media-kitchen production of agar plates and broths from approved powders), rules for “in-house exemption” may apply in specific cases (see Article 5 in the EU regulations; excerpt below).
  3. From a EUCAST perspective, products which have acquired IVDR, or CE “status” may or may not match the quality criteria set by EUCAST. Failure to match the quality recommended by EUCAST will, when ascertained by EUCAST, illicit a warning (https://www.eucast.org/ast-of-bacteria/warnings) against the product irrespective of IVDR or CE status.
  4. An organization which decides to refer to the IVDR exemption described under Article 5 (related to the in-house production of material), should in accordance with the IVDR, refer to EUCAST information available on the EUCAST website.

 

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Article 5 (from the EU IVD directive) on the exemption from the regulation

 

5. With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met:

 

  1. the devices are not transferred to another legal entity;
  2. manufacture and use of the devices occur under appropriate quality management systems;
  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 cannot be met at the appropriate level of performance by an equivalent device available on the market;
  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, modification 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 set out in Annex I to this Regulation and, where applicable, information on which requirements are not fully met with a reasoned justification therefore;
  7. as regards class D devices in accordance with the rules set out in Annex VIII, the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met. Member States may apply this provision also to class A, B or C devices in accordance with the rules set out in Annex VIII;
  8. the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (g) above; and (i) the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions. Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory. Member States shall retain the right to restrict the manufacture and use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions. This paragraph shall not apply to devices that are manufactured on an industrial scale.

 

EUCAST on IVDR is translated to French and German.