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European Commission’s Position Papers

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Subjects

European Commission Consensus Statements

Guidance Notes for Manufacturers of Class I Medical Devices

June 2009 MDEG

Guidance Notes for Manufacturers of Custom-Made Medical Devices

November 2009

Requirements for IVD kits measuring parameters to evaluate the risk of trisomy 21

2006

Clarification of “rare” blood groups and subgroups

December 2003 MDEG

Guidance document on Directive 2005/50/EC on the reclassification of joint replacements

2005

Management of Legacy Devices

08.02.2021

European Commission Interpretative Documents

Interpretation placing on the market of Medical Devices

November 2010

Interpretation of the Customs Union Agreement with Turkey in the field of Medical Devices

February 2010

Interpretation of the relation between the revised (AI)MDD and Machinery Directive

August 2009

Interpretation of the relation between MDD and the Directive on Personal Protective Equipment

August 2009

Interpretation of the Implementation of 2007/47/EC amending 90/385/EEC, 93/42/EEC and 98/8/EC

June 2009

Interpretation of the Medical Device Directives in relation to Medical Device own brand labellers

2008

Factsheets

Fact sheet on MDR requirements for Transparency and Public Information

Document from Commission services – DG Health and Food Safety – Unit B6 July 2020

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