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Regulating Medical Devices in the European Union: ­Legislation vs. Driving Business Outcomes

Recent legislation within the European Union has given rise to a spate of regulatory challenges. Businesses that produce medical devices must now shift their focus from regarding these matters as something a ­quality assurance department had to deal with to something that now affects the entire company. However, if properly conceived and executed, these regulations can lead to new and exciting opportunities.

When it comes to implementing new legislation, consultants often linger over the question of whether to start by focusing on the policy implications of the legislation or the overall business structure. Within the European Union’s medical device sector, the transition for small companies and start-ups from the old medical device directive (MDD) to the medical device regulation (MDR) legislation will not be an easy journey. Until recently, a company could register a Class I product by following a few procedures and having a point person register the device with the ­Danish Health Authority.

The requirements for the MDR quality system are much more extensive:

  • Managerial responsibilities – each company’s top ­management will be audited to ensure they fully understand the requirements and are able to implement, follow up on, and improve upon their business processes.
  • Risk Management – medical devices must now meet a level of risk management equivalent to ISO14971 for medical devices.
  • Clinical evaluation – this is a potential “showstopper” for small businesses. The costs associated with clinical evaluations and studies is both time-consuming and expensive, as it cannot be completed to the required level without external support from professional clinical advisors.
  • Post-market surveillance – there are new requirements for set-up, implementation, and maintenance of a post-market surveillance system. Companies can either try to manage this themselves or hire specialist companies to help with plans and reporting.
  • Monitoring and improvement – the new processes for monitoring and measuring output, data analysis, and product improvement can be value-adding as a competitive differentiator.

Though the new requirements are more extensive and requires implementation and compliance, we recommend prioritising the business-side to be able to implement legislation optimally. Once small businesses understand how to develop a solid foundation that gives them a dynamic and expandable structure, any legislation can be built on top of this foundation.

So how do we create this dynamic structure?

We start by distinguishing a quality system from a management system.

  • Traditionally, a Quality System is designed to the authority’s requirements and is rarely integrated ­throughout an organisation.
  • A Management System focuses on the business and requirements from various legislations (e.g., MDR and general data protection regulations). Laws governing work environments are just part of this larger system.

How to implement this in practice:

  • Define risks and opportunities to define the business ­issues to handle.
  • Following this risk assessment, define the structure of the business and the company’s main processes (e.g., order handling, development, production, sourcing, and quality).
  • Identify process owners for all processes, articulate the processes, and define the total workflow. This is no easy task. Based on previous processes, it will often come as a surprise what a process owner expects as input and believes is the right output. The best practice is to take your time describing these interactions and contract help as needed.
  • Implement legislative policies into the business’ ­processes. This requires competent process owners as well as competent resources within various legislations.
  • Employees with experience from e.g. management, production, quality and customer relations within the Medical Device Industry.

Instead of looking at MDR as an obstacle, business ­owners should see it as a golden opportunity to create an optimal structure from the start and collaborate with competent stakeholders and professionals within the medical device industry. This also paves the way for discussions with investors and other stakeholders as to why working in this industry requires significant investments – of time and money – in structures to be in compliance with the legislation. When properly implemented, MDR can serve as the foundation for a truly scalable ­business.