On 20 September 2011 a Report was issued from the Directors’ Contact Group between Commission, ECHA & Industry Associations on Meeting the 1st REACH Registration Deadline. The first deadline period was from FEB 2011 to MAR 2011. The Notes and
RoHS Recast Implications to EU Med & IVD Devices
The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: The recast of the Restriction of Hazardous Substances (RoHS) Directive has been released as 2011/65/EU. You can read the directive at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF. With the exception of
EC publishes draft regulation on electronic IFUs of Medical Devices
24 June 2011 – From Eucomed e-newsletter – European Commission publishes draft regulation on electronic instructions for use (IFU) of medical devices. ‘Stakeholders can send their comments by 8 August 2011. The Eucomed Alternative Labeling Task Force will meet on 1 July
Recasted RoHS Directive will apply to Med Dvcs & IVDs
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
Two Conf’s on 60601 Series of Stds Mar 3 & 4th
Come join Eisner Safety Consultants at one or both conferences March 3 & 4th. Both are related to the 60601 series of standards. On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and