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Dec 26
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The EU Medical Device Regulation Changes – A Brief Overview of Considerations

With 2019 on the horizon, 2020 will be here before we know it. Alongside the approaching New Year, the window for Medical Device manufacturers to adjust their products and processes so that they adhere to the proposed EU Medical Device Regulation (EU MDR) changes, now also draws to a close.

So what exactly is expected from device manufacturers? Companies affected by the changes will have to take a number of elements into consideration:

Legacy devices are likely to have been CE Marked under previous regulations: therefore, these will require re-certification as the CE Mark is due to become obsolete. Companies will also need to ensure that their technical documentation and clinical data all adhere to the new standards by 25 May 2020. In addition, Medical Device manufacturers will need to adjust their labelling, pertaining to the addition of Unique Device Identification (UDI) to all labels (as a result of the updated legislation).

The new legislation is lengthy, in fact, four times longer than the existing regulation. This is to accommodate for more detailed and/or extended definitions of regulated devices. New additions to the MDR include Medical Purpose Devices, Active Implantable Medical Devices (AIMD) and other non-medical and cosmetic devices which were not previously regulated. Examples comprise contact lenses, liposuction equipment and epilation lasers, as well as the products used to clean specific devices.

Stricter safety reporting requirements aim to ensure an unparalleled level of device safety for all patients in the European Economic Area (EEA). Under the new legislation, it will become compulsory for all device-related incidents, injuries and deaths to be reported into an EU portal. The timeline for reporting non-serious events will also be reduced from 30 days to 15.

The current safety profile of Company devices should be considered. As another means of making devices safer for patients, the risk classification of all devices will be reassessed. Devices that would be deemed “safe” under the current legislation could potentially be regarded as unacceptable when considering the standards of the new MDR. Companies may also need to revise their internal processes in terms of risk management, quality assurance and the current post-marketing expectations of their devices, to ensure they are up-to-standard under the updated criteria.

PharSafer Comment

PharSafer will provide more details concerning the changes required for Medical Device safety over the coming months.

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