New obligations for manufacturers and phased introduction of EUDAMED

The European Commission has published EU Regulation 2024/1860, which introduces the obligation for manufacturers to inform in the event of interruption of the supply of medical devices and provides clarifications on the phased introduction of the EUDAMED Database.

Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 was published on 9 July 2024 in the Official Journal of the European Union.

The Regulation amends the provisions relating to the mandatory use of the European Medical Device Database EUDAMED for devices compliant with the Regulations and for legacy devices and introduces the obligation for manufacturers to provide advance notice of the interruption or cessation of supply of a device that is considered to cause serious harm or a risk of serious harm to patients or public health.

Amendment of provisions on the use of EUDAMED

The Regulation allows for the gradual implementation of the modules of the European Medical Device Database EUDAMED as soon as they have been verified and declared functional through the relevant notice published in the Official Journal of the European Union.

The obligations and requirements related to EUDAMED will apply after 6 months from the date of that notice, with some exceptions, depending on the module.

New obligations in case of interruption or cessation of supply of devices

Regulation (EU) 2024/1860 also introduces the obligation for the manufacturer and any economic operator involved in the supply chain to declare in advance any shortage of stocks for so-called “critical” devices. This provision also applies to legacy devices.

In order to clarify the practical aspects related to the implementation of the gradual rollout of Eudamed under the MDR and IVDR, as amended by Regulation (EU) 2024/1860, the European Commission published on 21 November 2024 the document “Gradual roll out of EUDAMED – Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860”.

The latest timeline for the full implementation of the European Medical Device Database EUDAMED is available on the European Commission website.