This article is courtesy from BSI Healthcare eUpdate of 11-APR-2011. We send out thanks to BSI for such an informative and critical article for the medical device and IVD industries selling product in Europe (EU). Medical device manufacturers should be
MDD Harmonized Stds List updated 18-JAN-11
The latest update to the Harmonized List of Standards under the medical device directive (MDD) 93/42/EEC was issued on 18-JAN-11
EU Interpretative Doc on Placing Med Dev’s on Mrkt
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