Supply of HLS- and PLS-Sets

Exemption extended until September 30th, 2024

On September 29th, 2023, the European Commission decided to extend the exemption to supply HLS- and PLS-Sets in derogation from the conformity assessment procedure to the European Union Market based on Art. 59 para. 3 (EU) 2017/745 until September 30th, 2024.

As with the European Commission’s decision in March 2023 C(2023) 2353, this exemption is based again on a positive benefit-risk assessment which states:

“The interruption of care would have a direct impact on the treatment of patients, as the health and lives of patients would be acutely endangered by this measure. Weighing up these risks justifies the granting of a special approval/exemption in the current supply situation.”

Getinge is continuing the extensive work to secure compliance with essential requirements and to receive the CE-mark again.

Packaging improvements have been fully validated through aging, transport simulation and other tests. The supporting documentation and evidence for the HLS-Set was submitted to our Notified Body in April followed by the submission of the PLS-Set in May.
Our Notified Body has started to review our documentation and we are in a very close and constructive dialogue with them. While the lead time of the Notified Body and the timeline for the reinstatement of the CE-certificate cannot be predicted exactly, we expect a feedback from the Notified Body in the near future.