EU reference labs: Commission adopts implementing acts

Regulatory NewsRegulatory News | 21 June 2022 |  By 

A new set of implementing acts adopted by the European Commission outlines what EU reference laboratories need to consider in order to serve their customers. The regulations address issues such as how to ensure the labs have proper training and resources to handle workloads as well as how to ensure pricing transparency.
On 17 June, the Commission published two regulations on EU reference labs that may be used by notified bodies and member states to give technical assistance or scientific opinion on high-risk in vitro diagnostic products.
The first regulation outlines how the labs should be operated and ensure they are qualified to do their job. More specifically, it lists certain requirements, including employing the appropriate staff.
“In order to ensure compliance … the EU reference laboratories should have a sufficient number of technical and scientific staff,” the document states. “Minimum levels of education and professional experience for that staff and the EU reference laboratory director should be specified.”
“In order to ensure that the appropriate qualifications, knowledge and experience of the staff are maintained, the EU reference laboratories should be required to put in place a continuous training and education program,” it adds.
The labs are also required to document their equipment including specimens and control materials, and reference materials to ensure they are sufficiently able to do their work.
“As specimens, control materials and reference materials may be short-lived, the EU reference laboratories should have an acquisition plan in place to ensure their continuous availability,” the regulation added.
Another important issue covered in the regulation is that the labs are required to follow widely accepted standards.
“In order to ensure compliance … and given the variety and evolving nature of such international standards and best practices, the EU reference laboratories should identify which of those standards and practices apply to the activities within their scope of designation with a view to integrating them into their operating procedures,” the document states.
The act notes that EU reference labs may on occasion need to outsource their work to national reference laboratories and other member state laboratories due to the volume of work they receive, specific nature of the review and when dealing with potentially novel tests.
In such scenarios, the regulation outlines what is required of the EU reference laboratory when it needs to outsource its work including ensuring the external laboratory has the necessary staff and equipment, as there is no conflict of interest.
The main takeaway from the regulation is that EU reference labs should show they are able to do their job based on the people and resources they have and follow standards that give regulators assurance their work is scientifically sound and ensure they do involve themselves in work where there may be conflicts of interest.
The second regulation published by the EU deals with how EU reference laboratories may get paid for their work.
“Where notified bodies and Member States request scientific or technical assistance or a scientific opinion from EU reference laboratories … those laboratories may levy fees to wholly or partially cover the costs incurred in carrying out requested tasks,” the document states.
It notes that deciding on what to charge for different tasks and resources is at the discretion of the individual EU reference laboratories, but the key is they need to be transparent about how they decide their pricing.
“In order to ensure clarity, certainty and transparency, tasks requested of EU reference laboratories by notified bodies and Member States should be performed in accordance with predetermined terms and conditions,” state regulators. “Therefore, such activities should be covered by a contract between the requesting parties and the EU reference laboratories.”
European Commission


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