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Medical device recall reporting goes online

A new online system of reporting medical device recalls and adverse incidents Ð including contact lenses and prescription spectacles Ð has been launched.

The Manufacturers' On-Line Reporting Environment (MORE) has been established by the Medicines and Healthcare Products Regulatory Agency (MHRA).
It allows medical device manufacturers (who, apart from optical suppliers, include manufacturers of a wide range of products, from condoms to artificial eyes) to submit electronically full details of any medical device-related adverse incident or device recall direct to the MHRA. Details will then be transferred automatically into the Agency's incident tracking database.
The Department of Health said this week that MORE would provide manufacturers with a searchable library of all their MORE-based draft and submitted incident reports as well as enabling them to use the online adverse incident report form.
For the MHRA the system is envisaged to be an efficient, time and resource saving system.
Gordon Aylward, director general of the Association of British Healthcare Industry whose 225-membership includes Bausch & Lomb UK, J&J, Optos and Alcon, welcomed MORE.
He said: 'We anticipate that it will be a useful tool for medical device companies and we will encourage our members to use the system.'
A 'real renaissance' in European manufacturing was the focus of a briefing chaired by European Research Commissioner Philippe Busquin this week. The briefing highlighted the EMO Milano 2003 Fair in Milan, the world's largest trade event for the machine tools, robots and automation industries which attracted over 1,600 exhibitors from 38 countries and 200,000 visitors. It also emphasised the contribution of EU Research in support of the European manufacturing industry.

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