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.

It is planned that the EURL-IVDs will assume their functions in the evaluation of a9> the conformity of the products on 1 October 2024.

At present, all EURL-IVDs are establishing a network to coordinate and harmonise their working methods. They are all working both within a general network involving all laboratories and within specific networks. The general network and sub-networks are working on the harmonisation of methods, procedures, processes, etc., in particular on common laboratory testing procedures for performance verification and batch testing of devices. The work will also adopt common rules of procedure.

The fees to be used by the EURL-IVD are in line with the Commission Implementing Regulation ( EU) 2022/945 .

Rules for the establishment of the rates of the laboratories of a8> reference of the EU (EURL-IVD).

Structure of fees

1. The following categories of costs may be covered by the fees levied by the EU reference laboratories:

a) staff costs, including travel costs and associated accommodation and subsistence costs;

b) equipment costs, where the equipment is not provided by the manufacturer of the device to be tested;

c) costs of consumables, test specimens and reference materials;

d) shipping costs for samples;

e) translation costs;

f) general costs of the operation of the laboratory.

2. Without prejudice to paragraph 1, where the EU reference laboratory has a contract with another laboratory in accordance with Article 7(1) or (2) of Commission Implementing Regulation (EU) 2022/944 (2), the fee levied by the EU reference laboratory may cover the amount it paid to that laboratory in accordance with that contract for the performance of the requested task.

Level of fees

1. The fees levied by the EU reference laboratories shall be non-discriminatory, fair, reasonable and proportionate to the services rendered.

2. The EU reference laboratories shall set the fees based on incurred costs.

Where the calculation of incurred costs is unreasonably burdensome for a particular category of costs referred to in Article 1(1), points (a) to (e), the EU reference laboratories may estimate the incurred costs based on the average costs for that category.

The amount of the fee covering the costs referred to in Article 1(1), point (f), shall be determined by calculating a percentage of the combined costs referred to in Article 1(1), points (a) to (e), and shall not constitute more than 7 % of the those costs.

Rules for the calculation of fees

1. The EU reference laboratories shall lay down the rules according to which they calculate the fees for carrying out the requested tasks, including the rules for the estimation of incurred costs based on average costs, and shall make them publicly available on their websites.

2. The EU reference laboratories shall review the rules referred to in paragraph 1 at least every 2 years and, if needed, adjust them.

How do notified bodies work with EURL-IVDs?

All communications from manufacturers are made through the notified body chosen by the manufacturer. EURL-IVDs will liaise with notified bodies for the verification of medical devices for the

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.

In accordance with Regulation 746, Article 100-2h, European reference laboratories (ERLs) must provide recommendations on (i) suitable reference materials and (ii) reference measurement procedures of higher metrological order for their specific areas. This applies only to devices whose intended use is related to class D.

The purpose of sharing this information is to provide stakeholders in class D in vitro diagnostics (IVD) with access to references on standards and metrological traceability for IVD devices.

This information is provided in the following table, which includes international standards:

• CLSI EP32 – Metrological Traceability and Its Implementation
• ILAC P10:07/2020 ILAC Policy on Metrological Traceability of Measurement Results
• Establishing metrological traceability in laboratory medicine
• European Metrology Network (EMN) for Traceability in Laboratory Medicine (TraceLab Med)
• Factsheet for manufacturers of in-vitro diagnostic medical devices
• MDCG 2022-2 – Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)
• 6 Indicators to Evaluate Clinical Diagnostic Performance Of IVD Reagents
• MDCG 2020-16 rev.4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746.

According to IVD regulation 2017/746, Article 100 (2h), and 2022/944 (art 15) EURLs have to set up and manage a network of national reference laboratories (NRLs) after consulting with the national authorities and publish a list of the participating NRLs and their respective tasks. The purpose of this interaction is among others to favor collaborations, sharing know-how and testing methods.

For corresponding scopes, the NRLs that have been identified and with which there has been interaction for possible collaborations are:

Scope 2 (herpesvirus): Sahlgrenska Universitetssjukhuset (Sweeden)

Scope 3 (bacterial agents): Rijksinstituutvoor Volksgezondheid en Milieu (RIVM) (Netherland)

The tasks with these NRLs are planned to be (i) networking and (ii) harmonization of methods