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09-30-2007, 11:17 AM
The MHRA has ascertained, following detailed discussions with DEFRA (Department for Environment, Food and Rural Affairs), that the impact of the restrictions imposed to deal with the foot and mouth outbreak will have a minimal impact on the supply of medical devices containing animal material from cows, sheep, pigs, goats and other biungulates.

1. Devices containing animal material from other animal types are not affected.

2. Devices containing bovine, ovine, porcine, caprine or other biungulate animal materials that are sourced from overseas can be imported and moved about the country without any restriction.

3. Similarly there are no new or additional restrictions on the movement and placing on the UK market of products containing UK sourced animal materials of this type. Live animals from outside the controlled area can now be slaughtered and provide the source material for devices.

4. The only ban that is currently in place relates to the export of devices containing animal material of these types sourced from within the UK after 15 July which are not subject to other exemptions detailed in the Import and Export Restrictions (Foot and Mouth) Regulations 2007 (http://www.opsi.gov.uk/si/si2007/20072331.htm)(external link).

5. These exemptions though include in vitro diagnostic reagents and other products containing pre-processed animal material that has been imported from overseas (as long as it has been transported, stored and processed separately from other affected products). Furthermore devices containing UK sourced animal material from the specified groups which has been subjected to heat treatment in a hermetically sealed container with a Fo value of more than 3,00 or centre temperature raised to at least 70C, blood and blood products and finished composite products containing UK sourced animal material that has been certified by DEFRA inspectors can also be exported.

6. MHRA is pursuing the possibility of seeking an exemption to allow the export to other EC member states of all devices made in the UK containing animal material as long of course that they are legitimately CE marked in accordance with the requirements of the medical devices directives. However whether this will be necessary depends on how long the ban stays in place in light of the growing confidence in containment measures.

7. The risk of lifting the ban on exports of medical devices containing animal material in terms of controlling the spread of Foot and Mouth will be assessed by the Standing Committee on the Food Chain and Animal Health in considering whether an exemption can be granted. It should though also be noted that the clinical implications for humans are negligible. There has only been one recorded case of FMD in a human being in the UK which was back in 1966. The general effect was similar to influenza with some blisters and it is a short-lived self limiting disease. The Food Standards Agency have also advised that the disease in animals has no implications for the human food chain.

http://www.mhra.gov.uk (http://www.mhra.gov.uk/)