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Two are the criticalities emerged with the transition to the new regulation:
In these circumstances, the risk is that, from 26 May 2024, many devices will no longer be able to be placed on the EU market. To date, in fact, the devices certified under the MDR are about 2,000 out of a total of 23,000 certifications according to the former directives MDD/AIMDD [source Il Sole 24 Ore “Dispositivi medici: l’autogol dell’Europa alla innovazione” – 31 Gennaio 2023 n.30].
In the worst possible scenario, in a little over a year, many products will be withdraw from the European market because they are not certified. This will have an impact on the capacity of hospitals and the health of patients who no longer have access to essential medical devices.
In order to limit the risk of market failures and safeguard the availability of medical devices, the European Commission has proposed an modification to the transitional provisions for some medical devices and in vitro diagnostic medical devices.
However, the proposal, which is currently being examinated by the competent authorities, is subject to the application of special conditions to be met in order to benefit from the amendments. Manufacturers must therefore apply without delay to a notified body for certification.
Ente Certificazione Macchine, Notified Body No.1282 for Regulation (EU) 2017/745 (MDR), accepts new applications for certification to assess the compliance of medical devices with MDR requirements. Considering the increased complexity of the assessment process for the award of this certification, that is to say longer time frames than the previous MDD/AIMDD directives and also more stringent technical requirements, we invite manufacturers to contact us as soon as possible to submit the request for certification.
Contact us for further information at:
Eng. Diego Stevanella – Sales Manager ECM Medical Devices Division
email@example.com | mob. (+39) 393 2471040