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 [...]

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 summary of the Report are repeated below: Notes: The report is written with a multiplicity [...]

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 the items listed in Article 2.4, the RoHS Directive applies to all Electrical & Electronic [...]