TEAM NB Publishes Press Release on the Transition to the Implementation of Class D IVDs Oversight by EU Reference Laboratories
28 October 2024
In line with IVDR Article 100(1), Class D in vitro diagnostic medical devices must be tested by EU reference laboratories designated by the European Commission.
With the launch of the officially appointed reference laboratories, the TEAM-NB published a press release on 1 October on the impact on the conformity assessment of Class D devices whose technical categories must now be tested in the reference laboratories. This mainly has an effect on performance and batch verification. With regard to the applicable transitional measures, the press release refers to the document MDCG 2021-4 Rev.1 (view SCC news of 26 September 2024), while the annex of the document provides an overview of various scenarios for the performance and batch verification of Class D devices.
According to Article 100(2) of the IVDR, the reference laboratories are responsible for verifying the performance and compliance of Class D devices with the common specifications and for carrying out appropriate sampling. In addition, they support the Commission, the MDCG, the Member States and the Notified Bodies and advise them on the state of the art of certain devices. They establish a network of national reference laboratories and work on the further development of conformity assessment, market surveillance, reference materials and measurement methods and common specifications and standards.
To this end, the laboratories must have qualified staff, appropriate equipment, knowledge of standards and an appropriate administrative structure, and operate confidentially, independently and in the public interest (IVDR, Article 100(4)).
In December 2023, the Commission published the Implementing Regulation (EU) 2023/2713 for the designation of EU reference laboratories in the field of in vitro diagnostic medical devices. The annex contains a list of the designated EU reference laboratories proposed by the Member States and meeting the requirements of Article 100(4) IVDR. (View SCC news of 12 December 2023)
So far, the Commission has designated five reference laboratories, including the Paul Ehrlich Institute in Germany. These laboratories cover hepatitis and retroviruses, herpes viruses, bacterial pathogens and respiratory viruses. For arboviruses, hemorrhagic fever/biosafety level 4 viruses, parasites and blood grouping, the Commission is still looking for potential reference laboratories that meet the criteria and have sufficient overall capacity.
The 5 reference laboratories authorised by now took up their duties under Article 100(2) IVDR first on 1 October 2024 using the time beforehand to set up a network to coordinate their working methods and to give manufactures and notified bodies sufficient time to adapt their conformity assessment procedures accordingly.