SENSUS Group

Sensus offers specialist consultancy, training and resource in delivering and implementing compliance of the new EU medical device (EUMDR 2017/745) and in-vitro (IVDR 2017/746) regulations. WHAT DOES THIS MEAN? If you currently produce and/or sell medical devices or in-vitro devices, to continue to do so you will need to be compliant with the new regulations, their processes and be able to present all documentation legally required. There is a significant amount of work to be done to implement the new regulations and time is critical. Organisations will require significant resources and expert support, above and beyond the resources they already have to meet these strategic challenges within the transition period. The timeline for change, the absence of any sort of grandfathering clause for existing devices, the enormous complexity of the changes and the significant shift in regulations leads to an issue that needs to be addressed. The issue of fully understanding the new EU MDR & IVDR, conducting the gap assessments and analysis needed to identify where more work is required and plotting a course to compliance is time consuming itself, especially considering how much work needs to be undertaken. Sensus is best positioned to help you achieve the required compliance and support specific to your business needs.