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EU Team-NB adopted V3.0 Code of Conduct – Align to Recent Proposed Regulations

On 10 Oct 2012 The European Association for Medical devices of Notified Bodies (better known as Team-NB) issued a press release on the adoption of Version 3.0 of the Code of Conduct (CoC) for Notified Bodies under Directives 90/385/EEC (Active Implantable Medical Devices Directive), 93/42/EEC (Medical Devices Directive), and 98/79/EC (In-Vitro Diagnostic Directive) that is [...]

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EU medical device (MEDDEVs) guidance doc’s newly rls’ed or updated

The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther:   Below this article from Christine Ruther are several blog postings thx to Erik Vollegbret of Axon Lawyers but to read them you have to go to the bottom of this posting. Several European medical device guidance documents (MEDDEVs) have been [...]

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Electronic IFUs for EU MDD & AIMDD Devices

The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: The Commission Regulation of electronic instructions for use (IFUs) of Medical Devices 207/2012 was released 10 March 2012.  Here’s a general summary: The directive does not cover IVDD devices which have their own guidance document. In general, an e-IFU is allowed for: [...]

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Health Canada’s Guidance – Transition fr 2nd to 3rd ed. of IEC 60601-1 & related 60601 Series of Stds

Today (22 MARCH 2012) Health Canada (HC) has issued to manufacturer’s of record (those mfr’s with a HC License to sell & market product in Canada) a NOTICE titled “ADDITIONAL GUIDANCE ON TRANSITION FROM THE SECOND TO THE THIRD EDITIONS OF THE IEC 60601 FAMILY OF STANDARDS ON HEALTH CANADA’S LIST OF RECOGNIZED STANDARDS.”  HC has [...]

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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 [...]