Eisner Safety Consultants

The new MHRA website home page is now live and you are being sent to the Home Page of the newly revamped site! The UK MHRA has updated their website to be much more functional and you can find a lot of information about the Directives (i.e. MDD, IVD, & AIMDD) related to the medical [...]

Per Eucomed’s  7 October 2011 newsletter electronic labeling of medical devices (MDD & AIMDD) has been approved as a draft regulation and is in the hands of “the Council and European Parliament who will have 3 months to exercise their right of scrutiny and evaluate whether the European Commission has exceeded its powers with this [...]

16 Jan 2012 Just received an e-mail update on the status of the DRAFT NB-MED document on 3rd edition of EN60601 Implementation for the EU. The pertinent points are: 1) Substantial progress has been made over the last couple months on the document 2) The NB-MED has presented their observations and comments on the proposed [...]

Below is a copy from the FDA webpage on Innovation Pathway. Innovation Pathway Background on CDRH Innovation On Feb. 8, 2011, the FDA’s Center for Devices and Radiological Health launched its Innovation Initiative, which proposed actions the agency could take to help accelerate and reduce the cost of development and regulatory evaluation of innovative medical [...]

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 aware that it is not only the medical devices directives that are currently being considered [...]