As already happened for the Medical Devices Regulation MDR (EU) 2017/745, the European companies are mobilizing to request the postponement of the full application of the In Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017/746 (scheduled for May 26, 2022), due to delays caused by the Covid-19 health emergency, also pointing out that the number of Notified Bodies is too limited for certifications.
The reasons for the need to postpone the IVDR
Covid-19 blocked progress in the implementation of the Regulation and, in particular, it slowed down the certification processes of the European Commission for the competent Notified Bodies.
The operators of the IVD industry expressed strong concern for times that they consider too tight, as in order to be ready by May 2022, they should initiate applications for certification and authorization of their products as early as 2021.
For this reason, on July 9, 2020, MedTech Europe, European trade association representing the medical technology industries, from diagnosis to cure, published a document on which it urges the European Commission, Member States and the European Parliament to enact substantive solutions as soon as possible for the postponement of deadlines.
The IVDR (EU) 2017/746 requires very stringent requirements and, by postponing its date of application, the pressure on manufacturers and suppliers which are currently at the forefront of the pandemic, could be alleviated.
Few Notified Bodies for IVDR certifications
Currently, the European Commission selected only four Notified Bodies appointed to IVDR certifications and checks are being carried out to designate at least four other companies.
Companies operating in the field of in Vitro Diagnostic Medical Devices stress for the appointment of further Notified Bodies as soon as possible in order to be able to plan the CE marking programme for their devices immediately.
IVDR (EU) 2017/746: how to prepare for the best
The path to obtain the CE marking of devices and IVD in accordance with the regulation requires an in-depth analysis and a specific regulatory strategy.
Thema experts offer support to obtain CE marking according to IVDR (EU) 2017/746.
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