On 16 November 2010 this Interpretative Document was issued to explain what is considered Placing Medical Devices on the EU Market. The document refers to all 3 medical device directives including the amendment 2007/47/EC. The 3 medical device directives this applies to are Active Implantables Medical Devices 90/385/EEC, Medical Devices 93/42/EEC, and the InVitro Diagnostic Medical Devices 98/76/EC. Additionally, the biocidal products directive 98/8/EC is also referenced in this document.
This document refers to the EU Directive on accreditation and market surveillance relating to the marketing of products which is EC/765/2008. EC/765/2008 is relied on for the term “making available’.
The interpretative document may be viewed by clicking EU Interpretative Document – Placing Medical Devices on the Market.
To see a list of the current EU Medical Device Directives Interpretative Documents you can go to the EUROPA webpage that has the Medical Device Directives Interpretative Documents.