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Guide for Custom-made Medical Device Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994

18 June 2012

The Irish Medicines Board has revised guidance for Custom-made medical device manufacturers on compliance with European Communities (Medical Devices) Regulations, 1994. The guidance has been updated in line with amendments introduced by the coming into force of Directive 2007/47/EC and the related Irish transpositions S.I. No. 109 of 2009 and S.I. No. 110 of 2009. Further details on the changes can be found in the guidance document below.

Guide for Custom-made Medical Device Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994_tracked.pdf

Guide for Custom-made Medical Device Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994_clean.pdf





Date Printed: 24 April 2014

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