To: Class D WG and Regulatory Affairs IVD Committee
Dear members,
Regarding Class D devices under EURLs, please note to the recent press release from the TEAM-NB (Notified Bodies’ association) accessible via the following link.
The press release confirms Notified Bodies’ positive reception of the newly revised MDCG 2021-4 guidance and provides reassurance that the batch testing process will continue under the current framework until the EU Reference Laboratories (EURLs) are fully operational.
This is an encouraging development, as it ensures continuity in batch testing while we transition to the new system involving EURLs. We are looking forward to hearing from manufacturers about their experience with batch testing and cooperation with Notified Bodies and EURLs.
Please find the relevant citation from the press release below:
“The revision [of MDCG 2021-4] specifies that if testing cannot be conducted at the EURL—for example, but not limited to, logistical issues, verification or validation of equipment, training of staff etc. by October 1, 2024— NBs can continue with their current batch release process in place for Class D devices using the alternative methods employed prior to the EURL designation application. Taking this clarification into account, Notified Bodies (NBs) will continue releasing device batches using alternative methods until testing at the EURL for that specific device can commence. This approach ensures a smooth transition to operational status for EURLs, while preventing shortages of Class D devices in the EU market.”
