On Tuesday Feb 11, 2014 at the UBM Canon Communications MD&M West Conference Leo Eisner of Eisner Safety Consultants presented this material as the Track Chair for “Improving Risk Management Strategies And Procedures”. He spoke on the proposed Consensus Guidance Document on EN ISO 14971:2012 that is currently being drafted by NBRG (the Notified Body Recommendation Group). EN ISO 14971:2012 was harmonized under the 3 Medical Devices Directives (Medical Device, In Vitro Diagnostic, and Active Implantable Medical Devices Directives) on 30 Aug 2013 and was released with no transition period so there no warning publicly. So, this has caused a lot of confusion and the confusion still reigns among manufacturers, notified bodies, and others. Read thru the slide deck to get an idea of the process for this consensus document that will hopefully help all sides in understanding the requirements and being able to come to a reasonable solution for this very confusing matter to many stakeholders. To help in this process it is highly recommended that you, as a medical device manufacturer, get involved by providing some feedback via an anonymous survey on how your risk management process works and if you follow parts of the EN ISO 14971:2012 process or just the ISO 14971:2007 (or EN ISO 14971:2009 which is equivalent to the ISO 14971:2007 document).
The live link to the survey is on the fourth set of pages on slide deck and is slide 8 of the presentation. The more participants in the survey the more likely your voices will be heard and we hope this will improve the potential outcome of the process.
On 8 February we posted the NBRG letter which was a Call for Industry Participation in the Survey on Understanding Annex Z of EN ISO 14971:2012.
[slideshare id=32021997&doc=mdmwestpresentationonnbrgconsensusdocumentoneniso14971201211feb2014-140306235842-phpapp01&type=d]