Self-Care Medical Devices One Step Closer To Four-Year MDR Extension
Executive Summary
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.
You may also be interested in...
All Upgraded Class I Devices Could Benefit From 4-Year Extension As Corrigendum Details Emerge
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 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.
Prestige Expands UK Eye Care Range In Response To Consumer Demand
A “great consumer response” to TheraTears in the UK leads Prestige Consumer Healthcare to add TheraTears 5-in-1 Irritation and Redness eye drops to the range.