The designation act includes transitional provisions to allow EURL-IVD to network and harmonize their working methods and for manufacturers and notified bodies to adapt their processes to include EURL-IVD testing.

EURLs are scheduled to assume their role in product conformity assessment on October 1, 2024.

At the moment, all EURL-IVD are creating a network to coordinate and harmonize their working methods. They are working both in a general network with all laboratories and in specific networks. The general network and the sub-networks are working on harmonization 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 procedural standards.

EURLs’ fees are in accordance with Commission Implementing Regulation (EU) 2022/945.

Rules for Setting the Fees for EU Reference Laboratories (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-IVD?

We are currently working together with the NBGC Med-IVD Class D on how EURL-IVD and NBs will collaborate. All communications from manufacturers are made through the relevant Notified Body . EURL-IVD will have contact with Notified Bodies for testing of in vitro diagnostic medical devices and not with manufacturers.

How do notified bodies operate without EURL-IVD?

Class D products must be tested by the EU reference laboratory 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.

As for the conformity assessment of in vitro diagnostic medical devices without a designated EURL-IVD, these can still be certified by notified bodies and placed on the EU market in accordance with Regulation (EU) 2017/746.

EURL-IVD-related elements of conformity assessment do not apply to them until a EURL-IVD is designated. Refer to MDCG 2021-4 for guidance on how EURL-IVD should be integrated into the conformity assessment process once designated.

What if there is not yet a EURL-IVD for a Class D test domain?

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 expressions of interest for the remaining areas has been published and is being processed by the EC. Open expression of interest – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices – European Commission.

According to regulation 746-Article 100-2h, EURLs have to provide recommendations on (i) suitable reference materials and (ii) reference measurement procedures of higher metrological order for their specific scopes.

The purpose of sharing this information is that class D IVD stakeholders have availability of references regarding standards and metrological traceability of IVD devices.

This information (i) is provided below in the next table including international standards:

In relation to reference measurement procedures of higher metrological order (ii), some databases can be consulted. The JCTLM Database lists higher-order reference materials, measurement methods and services to be used in calibration hierarchies for value assigning calibrators and trueness control materials for quantities measured by in vitro diagnostic medical devices. The listed reference materials, measurement methods and services when applied following the models described in ISO 17511:2020, ‘In vitro diagnostic medical devices —Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples’, can be used to establish metrological traceability.

Besides JCTLM, other publications in relation to metrological traceability have been also selected as possible source of recommended procedures of higher metrological order and general framework for this topic:

• 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)