IVD Regulations In The EU
European Union reference laboratories for in vitro diagnostic medical devices (IVDs)
Under the EU Regulation 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR), EU reference laboratories (EURLs) will be required in verifying the performance of high-risk (Class D) in vitro diagnostic medical devices (IVDs).
Article 100 of the IVDR authorises the European Commission to designate EURLs for “specific devices, or a category or group of devices, or for specific hazards related to a category or group of devices” by means of implementing acts.
Moreover, as per Article 100(8), point (a) of IVDR; “The Commission shall specify by means of implementing acts: (a) detailed rules to facilitate the application of paragraph 2 of this Article and detailed rules to ensure compliance with the criteria referred to in paragraph 4 of this Article.”
Article 100(2) sets out the tasks of the EURLs and paragraph 4 lists the criteria the EURLs must meet.
Commission implementing regulation (EU) 2022/944, on ‘laying down rules for the application of Regulation (EU) 2017/746 as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices’, was published in June 2022 in the Official Journal of the European Union.
Application Of Regulation (EU) 2017/746
The regulation lays down rules for the application of Regulation (EU) 2017/746 as regards to EU reference laboratories (EURL), as outlined in Article 100 of the IVDR.
The criteria for the EURLs include items such as appropriate equipment and staff, a suitable administrative structure, knowledge of international standards and best practices as well as confidentiality.
The regulation also sets out the tasks required by the EURLs in order to ensure proper application of the IVDR and these include compliance with common specifications, sample or batch testing and ensuring contracts are in place for the execution of tasks requested by a notified body or a Member State.
Furthermore, Commission Implementing Regulation (EU) 2022/945, on fees that the EURLs can levy from notified bodies and Member States was also published in the Official Journal of the European Union in June 2022.
In July 2022, the EU Commission issued a call for applications for designation of EURLs under the IVDR. Member States now have the opportunity to submit applications on behalf of potential EURLs for class D IVDs.
Compliance with the criteria described in Article 100(4) of Regulation (EU) 2017/746 and the Commission Implementing Regulation (EU) 2022/944 is necessary for candidate laboratories in order to be considered.
The European Commission recommended a deadline of 5 January 2023 for candidate laboratories to apply to their Member States.
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