Self-Care Medical Devices One Step Closer To Four-Year MDR Extension
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.
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The text of the EU’s proposed second corrigendum to the Medical Device Regulation is available. It promises to lift the pressure on notified bodies and manufacturers alike.
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.
“You can’t just live off the brand equity anymore,” warned J&J's Consumer Health's Manoj Raghunandanan during the ‘Advancing Trust in the Self-Care Industry’ webinar co-hosted by the Global Self-Care Federation and HBW Insight. “You’ve got to continue to build that trust between consumers and products day-in day-out.”