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Joined: Sep 2010
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Sage
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Sage
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Hello! What are the necessary's requirements aside form technical specification of a medical equipment being procured. Example are C.E. mark or equivalent, FDA certificate, any more?


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My suggestion would be to ensure you get in writing a required amount of years the manufacturer will support the device. Its also good to establish any technical training. And also they can supply spares.


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Hero
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All products must meet MRHA rules - The UKCA marking
This is the conformity marking used for products being placed on the market in Great Britain (England, Scotland and Wales).The UKCA marking applies to most products for which the CE marking can also be used.

Different rules apply in Northern Ireland.For products that can use a UKCA marking in Great Britain, these must meet EU rules in Northern Ireland, including a CE marking.
SEE: UKCA Conformity

There are a few aricles about procurement here https://www.ebme.co.uk/articles/management

Last edited by John Sandham; 29/01/24 11:44 AM.

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