by Wellington Merritt

The EU Medical Device Regulation (MDR) is a uniquely challenging compliance effort due to its breadth and depth as well as its challenging timelines. Over the next few months we will be sharing insight and opportunities to help provide structure and clarity to one of the most complicated regulatory compliance projects in history. While the regulation is still being digested by notified bodies, and laws are being transformed into rules and norms, the general structure and flow are becoming clearer and help the informed medical device professional internalize what this all means.

The Requirements flow in a similar manner to the normal Commercialization Process, with a key point that upstream changes will often if not always have some downstream effect. This lends itself to a process flow which takes the requirements in a certain order to avoid rework.


The requirements naturally flow from Clinical - Risk - Design - Manufacture - UDI + Labeling - Economic Operators - Vigilance - Technical Documentation.

The level of fundamental change varies from function to function and is also variable on impact of existing directives that will be more uniformly enforced under MDR.  General indicators of potential gap are intuitive in that Device Classification will dictate risk (Class III Devices will have the highest burden) and Older Devices will have more potential issues with State of the Art considerations. However, the complex relationships and hierarchies of documents and the extremely varied points of compliance make establishing a generic classification of delivery risk exceedingly hard. For this reason, a robust Document Data Network Model is the cornerstone of a successful Program Integration Structure. Overall the content variables are too numerous to list concisely, however we will go into more detail in subsequent updates.

Overall there are a few major concerns for firms wishing to place devices in Markets requiring the CE mark. First, is that this is simply going to require immense effort to perform all of the assessment and remediation.  Second, we still have not found interpretational terraferma as the law has not been solidified into rules and norms yet.  Notified Bodies won’t be certified until 2019, and this leaves inherent uncertainty in the regulatory positions of all firms. Third, the process of drafting budgets, forecasts, and resource plans is unprecedentedly non-linear and complex.  

Given the current Academic Bodies of Knowledge out there, none are equipped to handle the variability and potential industry bandwidth issues induced by MDR with any sense of refinement.  It is conceivable that certain types of service providers are completely consumed by early remediation to the point where it may impossible to get some 3rd party testing done. It is also conceivable that every potential consultant and contractor for certain niches will be off the market prior to some firms recognizing their needs for that niche.  To these points, the firms who develop dynamic and resilient strategies early in the process will be best positioned for all the potential curveballs and hiccups in the process.

USDM provides a unique option for firms looking to place themselves ahead of the industry.  We have Life Sciences Industry Veterans who have extensive MDR exposure with some of the largest firms in the world. With Domain Expertise in every aspect of MDR’s impact and Compliance Program Integration, USDM can provide a dynamic strategy to achieve a low risk path to compliance for any Medical Device Manufacturer.

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