New MedTech Europe Reflection Paper, Is the IVD Regulation Framework ready for Class D Devices?

Posted on 05.11.2020

MedTech Europe has published a reflection paper, ‘Is the IVD Regulation Framework ready for Class D Devices?’, which can be found on MedTech’s Europe public website under this link.

The reflection paper is intended to identify and raise awareness of those devices that are currently self-declared under the IVD Directive and will become Class D under the IVDR. These devices are especially vulnerable to the IVDR transition period because they cannot benefit from the so-called “grace period” that extends to 27 May 2024. Of serious concern is the fact that around 18 months away from the IVDR date of application, the specific Class D conformity assessment infrastructure is limited or missing altogether. The situation for these high-risk devices is an example of the wider issues around the lack of infrastructure to support all IVDs which will need to transition to the IVDR by 26 May 2022. MedTech Europe, therefore, asks for an urgent discussion to take place with the relevant parties, including the European Commission, National Competent Authorities and interested stakeholders in order to identify actions to smoothly transition these devices to the IVDR and safeguard continued access to these high-risk IVD devices.

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