New MDR/IVDR amendment: transitional provisions for IVDs, EUDAMED, new Art. 10a

On 9 July 2024, a new amendment (EU) 2024/1860 to regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) was published. The amendment particularly contains transitional provisions for certain in vitro diagnostic medical devices, a gradual roll-out of EUDAMED and the obligation to inform in case of interruption or discontinuation of supply.

The third amendment brings expected extensions to the IVDR transitional periods. These correspond to the already known transitional periods of the MDR and lead to the following new periods:

The individual electronic systems of the EUDAMED database will be gradually implemented after the functionality has been verified. Therefore, each module will undergo an independent audit, and then a notification will be published stating that the module is functional and meets the required specifications.

The updated timeline illustrating the gradual roll-out plan for the EUDAMED modules can be viewed on the European Commission website (last updated 10 July 2024 and available here)

Surprisingly, a new Art. 10a has also been added, which contains new information obligations for manufacturers in the event of interruption or discontinuation of the supply of certain medical devices. Art. 10a para. 1 provides:

Where a manufacturer anticipates an interruption or a discontinuation of the supply of a device and where it is reasonably foreseeable that such interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health in one or more Member States, the manufacturer shall inform the competent authority of the Member State where it or its authorised representative is established, as well as the economic operators, health institutions and healthcare professionals to whom it directly supplies the device, of the anticipated interruption or discontinuation.

This provision contains numerous undefined legal terms and thus creates legal uncertainty in various areas for the economic operators concerned. It is advisable to keep an eye on the new regulations of the competent authorities and future guidance documents. It is crucial for manufacturers to adapt their own quality management system in timely manner. This is because Art. 10a will apply from 10 January 2025.

There is already a draft Q&A from the Commission (for further information, please contact us directly). It contains helpful explanations of the undefined legal terms contained in the standard. For example, you can find answers concerning: What is an "interruption or discontinuation of supply"?

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