Self-Care Medical Devices Sitting In The ‘Danger Zone,’ AESGP Warns
The Association of the European Self-Medication Industry (AESGP) warns that many self-care medical devices could fall through the cracks of implementing new EU regulations, as the deadline draws near.
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Self-care medical devices may be included in the four-year “grace period” following implementation of the new EU Medical Devices Regulation as part of an incoming corrigendum to the law, a spokesperson for the European Commission suggested at a recent AESGP meeting.
A lack of progress on the botanical health claims issue and rising tensions with the impending Medical Devices Regulation were among the topics discussed at the AESGP's Regulatory Conference in Brussels yesterday.
To Ensure Continued Availability Of Self-Care Devices In Europe, EU Commission Must 'Stop The Clock' On MDR
As the implementation deadline for the European Union's Medical Devices Regulation creeps ever closer, substance-based medical devices such as nasal sprays and throat lozenges are in danger of slipping through the net of re-certification. TÜV SÜD, one of only four notified bodies to be approved for re-certification under the new rules, says the EU should "stop the clock" on implementation to ensure these products continue to be available in Europe after the deadline.