Self-Care Devices May See Extension After EU Commission Admits MDR ‘Inconsistencies’
Self-care medical devices may be included in the four-year “grace period” following implementation of the new EU Medical Device Regulation as part of an incoming corrigendum to the law, a spokesperson for the European Commission suggested at a recent AESGP meeting.
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Members of the European Parliament will soon decide whether to grant self-care medical devices such as nasal sprays and throat lozenges the same four-year extension as high-risk devices under the new EU Medical Devices Regulation implementation rules.
It looks, at long last, as if the European Commission may be making an important concession that could ease the pressure on the medical device sector as it implements the new EU Medical Device Regulation. The concession would allow more time to focus on higher-risk devices.
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