Are you as a Medical Device manufacturer ready to face the new challenges?
A revised regulatory strategy is required to set up a plan considering all the changes in the various regulations. In general, the new strategy and plan will cover two or three timelines depending on whether the products deal with personal data as defined in the General Data Protection Regulation.
The first timeline covers the implementation of ISO 13485:2016 considering that March 1, 2019 is the critical date. That said, it is also relevant to consider the fact that the 2016 version will be “state of the art” to be used for showing compliance, when it is published in the Official Journal of EU.
The second timeline shall cover the transition from MDD to MDR, which in most cases will vary from one product to another depending on:
The third timeline is very important if the products deal with personal data as defined in the General Data Protection Regulation that will apply from May 25, 2018. Relevant for devices with incorporated software, standalone software like Apps or software systems handling patient data. Observe that Personal Data and Information Security are also addressed in the MDR.
What could be the first steps right now:
.We are for sure looking into a very exciting time with a lot of new challenges we have to face sooner or later.
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