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REACH & CHiP Information/Guidance – Medical Devices
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Posted By John Smith
Hi, I’m looking for information or guidance on the packaging and supply of medical devices. EU legislation states that “devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device” The legislation goes on and refers to classification, packaging and labelling.
The devices are used to administer and/or remove medicines, body fluids or other substances and can be used for transporting and storage of such fluids which can be classed as carcinogenic, mutagenic or toxic to reproduction.
Do you know of any best practice guidance, ACOP or information? Do you have personal experience of REACH and CHiP as applied to medical devices
Thanks in anticipation, John
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Rank: Guest
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Posted By martinw
John
I have no experience but you could get in touch with the Medicines and Healthcare Regulatory Agency, who formed in 2003 - the Medical Devices Agency and the Medicines Control Agency merged to form the MRHA and they manage and inspect medical devices and medicines. They are part of the DoH and I hope that if anyone can point you in the right direction, they can. The document below should give an introduction to the organisation.
http://www.mhra.gov.uk/h...resources/con2031677.pdf
They are on 020 7084 2000, based in London but also have other offices - York, Welwyn Garden City being two I know of. If you go to their main website homepage and look in the a-z, they have listings for Devices which may be specific enough for your enquiry.
All the best
Martin
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