News Category: Regulatory news
Two draft implementing acts on European Union Reference Laboratories (EURLs) have been made available on the European Commission’s portal. These draft implementing acts relate to the designation of EURLs for high-risk IVDs under Article 100 of IVDR 2017/746.
The first act relates to EURL tasks and criteria. While Article 100(4) sets out the criteria the EURLs must satisfy, this act lays down detailed rules to ensure compliance with the criteria and covers areas such as the qualifications of staff, confidentiality, accreditation, international standards and best practices. Similarly, Article 100(2) of the IVDR sets out the tasks that EURLs carry out, and this same act lays down rules to facilitate the application of those provisions. These rules relate to areas such as written contracts, the verification of performance and compliance with common specifications, requests from notified bodies, and sample/batch testing.
The second act relates to EURL fees. This act sets out the structure of fees, the level of fees that can be applied and the rules surrounding the calculation of fees.
The public consultation will be open until 17 December 2021. You can provide feedback to the Commission via the above links and also view the Commission's rules on providing feedback.