Commission Implementing Regulation (EU) 2022/945 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and the Council with regard to fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/945
• Articles: 4

Article 1 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.

Article 2 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.

Article 3 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.

Article 4 Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .