Guide for Class I Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994
27 August 2010
The Irish Medicines Board has revised guidance for Class I 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 Class I Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994_tracked.pdf
Guide for Class I Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994_clean.pdf