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
1 Step Closer to EU Medical Device e-Labeling
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
Update on DRAFT NB-MED EN60601 3rd ed. Implementation for EU
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
DRAFT results implementation of 3Ed (EN60601 series) for CE marking
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
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