This post is a status update on the NBRG RMWG Risk Management Consensus Document
30 April 2014 – The NBRG (Notified Body Recommendation Group) Risk Management Working Group (RMWG) membership will have a face to face meeting in mid May to refine the draft Consensus document on EN ISO 14971:2012. This meeting has come about because the NBRG RMWG received some feedback recently from the EU Commission and they will consider it and roll it into this document.
The consensus document’s purpose is to reduce the confusion around the EU Harmonized Standard EN ISO 14971:2012 Annexes ZA, ZB, & ZC that amends the EN ISO 14971:2009 version of the standard to align with the 3 Medical Devices Directives (the Medical Device, Active Implantable Medical Device, and In Vitro Diagnostic Medical Devices Directives). The previous plan was to have this Consensus document completed and released by Mid to Late April ’14 but at this point it is hoped the NBRG RMWG will have a final released document by the end of June 2014. We look forward to sending good news about the progress of this document over the next month or so.
If you would like further info on the consensus document and some history please check out the previous posts below (Latest to Oldest):
- MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012”
- NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation
- NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012