Regulation Update

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The legal department of a major manufacturer turned to Waddell Group to help prepare for new regulations in Europe that threatened their entire European operations. This new regulatory environment could significantly impact their business, with the potential for completely uprooting their presence in Europe.

Regulation (EU) 2017/745, also known as the European Medical Device Regulation (MDR) is an active regulation that features increased restrictions and stricter oversight on the development and sale of medical devices in the European Union. Every previously approved product and its associated quality process had to be resubmitted to the European Union to qualify for the market. This could have resulted in the majority of their products losing their profitability, or even being forced out of the market. Properly accounting for the hidden costs associated with meeting regulations is a difficult task, especially with the multitude of component and final SKUs present in the manufacturer’s portfolio.


Waddell Group performed an overarching business analysis at the onset, including cost analysis and gap analysis to determine product feasibility in Europe and the manufacturer’s resource capacity to meet the new regulatory requirements.

We worked closely with the legal and regulatory departments to set up a system of strategic product availability. By determining the cost-effectiveness of each product and accounting for the loss of profit from component parts that are required for important final products, Waddell Group was able to uncover the manufacturer’s projected return on investment. Our ROI analysis accounted for the cost of updating volumes and returns, revising quality standards, and completing the necessary regulatory efforts for compliance.


After determining the feasibility of the manufacturer’s product offerings in Europe, Waddell Group assisted the client in establishing a compliance department tasked with gathering the required material to meet regulations. Waddell Group generated the processes, tools, and training necessary for a well-functioning compliance department that could help the client reach compliance in the desired time frame. By completing this process within the tight deadline, Waddell Group prepared the client for the impending enforcement of new regulations, opening the door for the client to operate at full capacity in Europe.

Waddell Group held a cross-functional role during the project which resulted in the successful implementation of a new compliance department, as well as a completely revised product development and a quality control process that was compliant with new European regulations. Waddell Group’s flexibility and consultative approach were primary contributors towards the client meeting a strict deadline that threatened their European presence.


Our highly experienced consultants have much more than just a strong project management pedigree. They know how to lead teams, manage in times of crisis, and create solutions that result in long-term success and profitability. Our world-class project managers bring with them a proven methodology that will influence change in your organization, regardless of its size or location of operation. If this interests you, contact Waddell Group today and set your company up for success so you can rest easy knowing that you’re heading in the right direction.

Date: 27 April, 2016

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