The European Commission has updated its guidance for manufacturers of Class I (low-risk) medical devices to help them comply with new legislative requirements that come into effect next year1.
The revised guidance is aimed at helping Class I manufacturers meet the requirements of national legislation transposing Directive 2007/47/EC, the amending directive which amends the Medical Devices Directive (Directive 93/42/EEC) and the Active Implantable Medical Devices Directive (Directive 90/385/EEC)...
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