98/8/EC – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Wed, 01 Dec 2010 19:43:29 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png 98/8/EC – Eisner Safety Consultants https://eisnersafety.com 32 32 EU Interpretative Doc on Placing Med Dev’s on Mrkt https://eisnersafety.com/2010/12/01/eu-interpretative-doc-on-placing-med-devs-on-mrkt/?utm_source=rss&utm_medium=rss&utm_campaign=eu-interpretative-doc-on-placing-med-devs-on-mrkt Wed, 01 Dec 2010 19:43:29 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=1940 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.

]]>