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Eisner Safety Consultants: Qmed Qualified Supplier
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EC asks for further scientific study & draws 1st lessons from recent fraud on breast implants

From the Europa website the following press release was issued on 2 Feb 2012. The complete press release is below.  The original press release may be viewed too. European Commission – Press release Medical devices: European Commission asks for further scientific study and draws first lessons from the recent fraud on breast implants Brussels, 2 [...]

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UK MHRA Revamped Website!

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 [...]

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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 right of scrutiny and evaluate whether the European Commission has exceeded its powers with this [...]

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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 on the document 2) The NB-MED has presented their observations and comments on the proposed [...]

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