The European Commission recently adopted two new regulations laying down rules for the application of Regulation (EU) 2017/746, as regards to the tasks of and criteria for European Union's reference laboratories in the field of In Vitro Diagnostic (IVD) for medical devices, and the fees that may be levied by reference laboratories.
Commission Implementing Regulation (EU) 2022/944 addresses the criteria that EU reference laboratories are to satisfy pursuant to Article 100(4) of Regulation (EU) 2017/746, establishing detailed rules to ensure compliance with those criteria.
According to Implementing Regulation (EU) 2022/944, EU reference laboratories shall:
- Have sufficient staff to fulfill the tasks included in each laboratory’s scope of designation (i.e., in the field of specific devices, categories or groups of devices, or specific hazards related to a category or group of devices for which the EU reference laboratory is designated), and shall put in place a continuous training and education programme for their staff;
- Keep up-to-date documentation on equipment and reference materials necessary to carry out the tasks assigned to them within their scopes of designation, including a procurement plan;
- Keep up-to-date documentation evidencing that they have integrated the international standards and best practices that apply to the tasks assigned to them within their scopes of designation into the respective operating procedures;
- Comply with governance duties, notably identifying one person within management as having overall responsibility for the performance of the tasks set out in Article 100(2) of Regulation (EU) 2017/746, and keeping up-to-date documentation on corporate structure and organisation; and
- Have internal policies on confidentiality, and on independence and conflicts of interest.
Implementing Regulation (EU) 2022/944 further develops the scope of the tasks of the EU reference laboratories as depicted in article 100 of Regulation (EU) 2017/746, notably addressing the contracts that must be in place and the procedures that must be adopted for the execution of tasks requested by a notified body or a Member State, or by the Commission.
Commission Implementing Regulation (EU) 2022/945 contains measures to achieve transparency with regard to the structure and level of the fees the EU reference laboratories may levy to wholly or partially cover the costs incurred in carrying out requests from notified bodies or Member States in respect of scientific or technical assistance or scientific opinions.
This Regulation defines the structure of fees levied by the EU reference laboratories, and entrusts EU reference laboratories with the task of laying down rules according to which they calculate the fees for carrying out requested tasks further determining such fees shall be non-discriminatory, fair, reasonable and proportionate to the services rendered.
Both Implementing Regulations are effective from 10.07.2022.