Guidance Documents

Guidance Notes for Manufacturers of Class I Medical Devices
⇨ Guidance Notes for Manufacturers of Class I Medical Devices endorsed by the MDEG on December 2009

Relation between 93/42/EEC and 89/686/EEC
⇨ Relation between the revised Directive 93/42/EEC concerning medical devices and Directive 89/686/EEC on personal protective equipment

Guidance Notes for Manufacturers of Custom-Made Medical Devices
⇨ Guidance Notes for Manufacturers of Custom-Made Medical Devices endorsed by the MDEG on June 2010

Guidance document on Dir. 2005/50/EC
⇨ Guidance document on Dir. 2005/50/EC endorsed by the MDEG on December 2006

IVD Trisomy 21
⇨ IVD Trisomy 21 endorsed by the MDEG on December 2006

IVD Rare Blood Groups
⇨ IVD Rare Blood Groups endorsed by the MDEG on December 2003

Interpretation of 2007/47/EC
⇨ Interpretation of implementation of Directive 2007/47/EC

Manual on Borderline Classification
⇨ Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices

EU Commission Recommendation
⇨ EU Commission Recommendation Regarding Unannounced Audits

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