Medical instruments to be tested in the same way as medicines

Medical instruments are to be tested and monitored with the same rigour as medicines as from May in an EU decision taken after an initiative during Malta's presidency of the bloc.

The Ministry of Health said on Wednesday that Health Minister Chris Fearne has moved a bill in parliament requiring the more intensive testing and shifting monitoring responsibility from the Competition Authority to the Medicines Authority.

The ministry explained that medicines are intensively tested before being launched on the market, and their ingredients can be traced right back to their origins. The same currently does not apply for medical instruments, even those eventually implanted into patients.

This shortcoming had come to the fore when the case of harmful breast implants hit the headlines.

The new legislation will give the health minister the authority to issue regulations on the standard of medical instruments and lay down penalties for defaulters.

The ministry also observed that this could be a new economic activity for Malta in the same way as medicines are tested here before being licenced for use throughout Europe