November, 2017, Brussels.  We knew EN ISO 13485:2016 would eventually replace the 2012 edition, we just didn’t know exactly when.  Now we know.  The last time the EU updated the AIMD, MDD, and IVDD harmonised standards lists, a liberal Democrat was in the White House, and he wasn’t calling the ruler of North Korea ‘short and fat, but maybe one day they could be friends.’  Fast forward to today – things have surely changed in the World – and specifically in Europe with regard to the harmonised standards demonstrating conformance with EU Directive Essential Requirements.

What may be the last standards listings for the AIMD, MDD, and IVDD (last because the next listing may be for the MDR and IVDR), have standards which we knew were going to be harmonised, including EN ISO 13485:2016, as well as a few surprises, including EN 60601-1-8, concerning medical device alarms.  The cessation of conformity for EN ISO 13485:2012 is 31 March 2019.  On the other hand, we have more time to comply with the latest EN 60601-1-8 – until July, 2020.  But, as we all know, design changes and new design projects sometimes take longer than expected, so if your new design or change is for a medical device with alarms, or your ISO 13485 certificate expires in 2019, now is the time to get familiar with the new requirements to maintain the status quo.

The CRO Group specialises in assisting SaMD developers and medical device manufacturers achieve CE Mark as well as FDA clearance, and has the scoop on what new standards and new revisions are applicable, and most important, when the Notified Bodies are looking for conformance.  For the lists, click AIMD, MDD, or IVDD.   If this is all new to you, or you prefer to hire a consultancy to review your projects and provide the info you need so there’s no CE Mark impact, and especially,  if you’re in the Boston area and would like to



Like us to find out how.