Malta Chamber of SMEs council members meet Prime Minister Robert Abela
14 January 2022
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The EU is proposing updated regulations
on medical devices – from home-use items like sticking plasters, pregnancy
tests and contact lenses to x-ray machines, pacemakers, breast implants, hip
replacements and HIV blood tests. The aim is to ensure these products are safe,
and can be freely and fairly traded throughout the EU.
Existing EU rules – dating back to the
1990s – have not kept pace with the enormous technological and scientific
progress in the past 20 years. Moreover different EU countries interpret and
implement the current rules in different ways.
PROPOSED FOR REVISION
The main changes being proposed at this
WHO WILL BE
Representatives, Importers, Distributors and Users of medical devices.
WILL BE AFFECTED?
The following products fall under the
scope of the regulations:
Feedback or requests for clarifications
must be sent on by 30th November 2012.
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