Update on the new Art. 10a MDR

With the introduction of the aforementioned Article 10a MDR (please also see our post), a new obligation for manufacturers was introduced to report six months in advance if it is reasonably foreseeable that a disruption in the supply or discontinuation of a device could result in serious harm to patients or public health.

This new obligation will come into force on January 10, 2025 and must be integrated into the manufacturer´s QMS.

In the meantime, the European Commission published a Q&A document on this subject in October 2024.

In addition, the Commission has now published another important document: the manufacturer information form, which can be found here: MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices.

Also in the making is a “decision tree”, which is currently still being discussed between the member states.

If you have any questions, please do not hesitate to contact us.