32024R1860REGadopted 2024-06-13

Regulation (EU) 2024/1860 of the European Parliament and of the Council

3 articles19 recitalsOfficial text on EUR-Lex →Legislative file 2024/0021(COD) →

Articles

Recitals

Recital (1)Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament and of the Council establish a regulatory framework to ensure the…
Recital (2)Regulations (EU) 2017/745 and (EU) 2017/746 require the Commission to set up, maintain and manage Eudamed, which includes seven…
Recital (3)Pursuant to Regulations (EU) 2017/745 and (EU) 2017/746, the obligations and requirements that relate to Eudamed are to apply from a…
Recital (4)The use of the electronic systems that are completed or that are about to be completed would largely support the effective and efficient…
Recital (5)Having regard to the gradual roll-out of Eudamed’s electronic systems and to avoid overlapping periods of registration in national…
Recital (6)Due to the delay of the development of the electronic system on clinical investigations and performance studies, the timeline for the…
Recital (7)Despite the increase in the number of notified bodies designated in accordance with Regulation (EU) 2017/746, the overall capacity of…
Recital (8)The number of applications for conformity assessment of in vitro diagnostic medical devices submitted by manufacturers and the number of…
Recital (9)It is very likely that many safe and critical in vitro diagnostic medical devices, which are essential for the medical diagnosis and…
Recital (10)In order to ensure a high level of protection of public health and patient safety, while safeguarding the smooth functioning of the…
Recital (11)The extension should be of sufficient duration to give manufacturers and notified bodies the time necessary to carry out the required…
Recital (12)The extension should be subject to certain conditions to ensure that only in vitro diagnostic medical devices that are safe and for which…
Recital (13)To ensure a progressive transition to Regulation (EU) 2017/746, the appropriate surveillance regarding in vitro diagnostic medical devices…
Recital (14)As regards the periods needed to allow manufacturers and notified bodies to carry out the conformity assessment in accordance with…
Recital (15)Having regard to the impact that shortages of certain medical devices and in vitro diagnostic medical devices can have on patient safety…
Recital (16)Regulations (EU) 2017/745 and (EU) 2017/746 should therefore be amended accordingly.
Recital (17)Since the objectives of this Regulation, namely to address risks of shortages of in vitro diagnostic medical devices in the Union and to…
Recital (18)This Regulation is being adopted in view of the exceptional circumstances arising from an imminent risk of shortages of in vitro diagnostic…
Recital (19)To allow manufacturers and other economic operators time to adapt to the obligation to provide notice of an anticipated interruption or…

Text as published in the Official Journal; for the authentic version, see EUR-Lex.