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Following the entry into force of the new European regulation for in vitro diagnostic medical devices in vitro diagnosticin accordance with Regulation 2017/746 or IVDR we solve the most frequent doubts that may arise.
What are Class D in vitro diagnostic medical devices or IVDs?
High-risk in vitro diagnostic medical devices (IVDs), known as class D, include any medical device consisting of a reagent, reagent product, calibrator, control material, kit, specimen container, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitrofor the study of samples from the human body, including blood and tissue donations.[1]
What are in vitro diagnostic devices in vitro diagnostic or IVDs class D?
High-risk in vitro diagnostic (IVD) devices, known as Class D, are those intended to detect high-risk infectious agents, such as HIV, hepatitis B and C, and other pathogens that pose a significant risk to public health. This category also includes tests for severe respiratory viruses and resistant infectious agents. Class D IVDs must meet strict safety and efficacy requirements because of the potential consequences of incorrect results, which could lead to inappropriate treatment or the spread of infectious diseases.
What does CE marking on Class D in vitro diagnostic devices mean and imply?
The CE marking on Class D in vitro diagnostic devices certifies that they comply with European Union with the safety and efficacy standards of the European Union, providing safety and confidence to health professionals and patients alike. Having an EU-designated laboratory for this task is crucial, as it ensures that the assessments are carried out by experts in compliance with the high regulatory requirements. This allows the product to be placed on the European market, ensuring that the product has been rigorously evaluated and meets the required health criteria.
What is the EURL-IVD status of CQS?
The designation act includes transitional provisions to allow EURL- IVDs to network and harmonise their working methods and for manufacturers and notified bodies to adapt their manufacturers and notified bodies to adapt their processes to include EURL-IVD testing.
In accordance with Commission Regulation (EU) 2023/2713 of 5 December 2023, designating European Union reference laboratories in the field of in vitro diagnostic medical devices European Union in the field of in vitro diagnostic medical devices, the CQS EURL-IVD is operational as of 1 October 2024 .
What will the EURLS fees be?
The fees to be used by the EURL-IVD are in line with the Commission Implementing Regulation ( EU) 2022/945 .
How do notified bodies work with EURL-IVDs?
All communications from manufacturers are made through the notified body chosen by the manufacturer. through the notified body chosen by the manufacturer. The EURL-IVD will have contact with the Notified Bodies for the verification of in vitro diagnostic medical in vitro diagnostic medical devices and not with the manufacturers.
There are two main types of verification: verification of the performance of the in vitro diagnostic medical device or IVD declared by the manufacturer, and the analysis of samples or IVD batches.
How do notified bodies function without EURL-IVD?
In vitro diagnostic medical devices have to be verified by the EU Reference Laboratory or EURL-IVD before they can be placed on the market, regardless of whether they are new or not. There are two main types of testing: performance verification and batch testing.
With regard to conformity assessment of in vitro diagnostic medical devices, the following are concerned in vitro diagnosticwithout a designated EURL-IVD , these can still be certified by notified bodies and placed on the and placed on the EU market in accordance with Regulation ( EU) 2017/746. Regulation (EU) 2017/746.
The elements of conformity assessment related to the EURL-IVD do not apply to them until a EURL-IVD is designated.IVD do not apply to them until a EURL-IVD is designated. See the MDCG 2021-4for guidance on how EURLs should be integrated into the conformity assessment process once designated. conformity assessment process once designated.
What if there is not yet a EURL-IVD for a Class D test area?
For the remaining 4 categories, namely arboviruses, hemorrhagic fever and other biosafety level 4 viruses, parasites and blood groups, either there were no laboratories meeting the criteria or their combined capacity was insufficient to cover the expected volume of requests.
A call for expression of interest has been published for the remaining areas, which is being processed by the EC. Expression of interest open – Possible second call for EU Reference Laboratories for high-risk in vitro diagnostic EU Reference Laboratories for high-risk in vitro diagnostic medical devices – Possible second call for EU Reference Laboratories for high-risk in vitro diagnostic medical devices European Commission.
More information about EURLS – IVDS: https://www.cqssalud.com/eurl/
More information on the designation of CQS as a European Union Reference Laboratory ( EURL-IVD): https://www.cqssalud.com/cqs-designado-laboratorio-referencia-eurl/
[1] Specifically, Regulation 2017/746 establishes that these medical devices for in vitro diagnosis will have the purpose of collecting information on all or some of the following elements: a) relating to a physiological or pathological process or state; b) relating to congenital physical or mental deficiencies; c) relating to the predisposition to an illness or disease; d) to determine safety and compatibility with potential receivers; e) to predict the response or reaction to treatment; or f) to establish or supervise therapeutic measures.