This article is an update to the June 24, 2011 article “EU EN IEC 60601-1 3rd ed. Request for Issues on the use of the Std for CE-Conformity” On October 1, 2011 the DRAFT “FAQ related to Implementation of EN
EU REACH Rprt DCG’s Achievements, Lessons Learned & Recommendations
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
FDA Issues Draft Guidance doc on Mobile “App’s”
On July 21, 2011 the FDA released a draft Guidance document on Mobile “App’s”. There is a 90 day period to submit comments for consideration. (See details on web link for draft guidance). The draft guidance document states in section
Health Canada Final Guidance – Reprocessing & Sterilization:Reusable Med Dvcs
On June 1, 2011 Health Canada issued a notice releasing the final guidance on ‘Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices.’ The following text has been taken straight from the Health Canada