The European Commission published for consultation, on Friday 19 November, two draft implementing acts relating to Regulation 2017/746 on in vitro diagnostic medical devices - the implementation of which has recently been postponed (see EUROPE 12821/9).
The two draft implementing acts will remain open for comments until 17 December before being finalised, taking into account the contributions received, the Commission promises.
Regulation 2017/746 authorised the institution to intervene by means of implementing acts on a number of issues, including the designation of European “reference” laboratories: those laboratories deemed competent to verify the performance and attest the conformity of in vitro diagnostic medical devices.
Criteria and tasks of the laboratories
In the first draft act, published on Friday, the Commission therefore details the criteria that reference laboratories will have to meet in order to be recognised as such and the tasks they will have to perform.
In the criteria section, the Commission specifies, for example, the nature of the equipment and materials to be used in these structures, the number of people to be employed and their qualifications. It also sets out rules on administrative organisation, confidentiality policy and respect for the public interest.
The provisions detailed in the “missions” section of the document, on the other hand, regulate in detail the tasks that will fall to these reference structures. The Commission clarifies, for example, the conclusion of written contracts between the laboratory and the manufacturer requesting verification. It also defines the time limit for the delivery of decisions by laboratories and the content of these decisions.
To access the consultation on this draft act: https://bit.ly/3HKen5v
Fees charged by laboratories
The second draft act published by the Commission concerns the fees that may be charged by reference laboratories.
Regulation 2017/746 provides that “where notified bodies or Member States request scientific or technical assistance or a scientific opinion from an EU reference laboratory, they may be required to pay fees to wholly or partially cover the costs incurred by that laboratory in carrying out the requested task”.
The Commission therefore proposes that these fees should cover, inter alia, staff costs, equipment costs, where this is not provided by the manufacturer of the device to be tested, the cost of shipping samples and translation costs.
For more details and to access the consultation on this draft act: https://bit.ly/3xavjgS (Original version in French by Agathe Cherki)