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European Regulatory Support for Business since 1995
We can be your Authorised Representative in the E.U.
CE Marking, Health & Safety . . .
Risk Management, Product Safety . . .

All class 1 Medical Device Manufactures must remember the need to ensure they comply with the Directive to maintain legality of supply. Failure to do so could result in product recall, product withdrawal from the market and damage to the manufacturers brand.

This requires risk management documents, clinical evaluations, essential requirements matrices, processes in place to comply with the relevant Medical Devices Directive and MEDDEVs.

Remember if they are supplied sterile or include measurement facilities they require a Notified Body to approve prior to being legal to sell in the EU.

For further detailed information from the MHRA website follow this link - http://goo.gl/e5cAJt

If you have any concerns about your products contact Atlantic Bridge who will be able to give you clear and informative guidance and information.