The new EU Medical Device Regulation and In Vitro Diagnostic Regulation are here and companies need to be deciding how they will address them. Approved by the European Parliament in May 2017, these new regulations are the biggest change to the legislative framework for medical device and in vitro diagnostic products in decades. As discussed in my previous blog on the subject, one aspect of this new legislation is the requirement to appoint a Person Responsible for Regulatory Compliance. This requirement has an impact on manufacturers and authorised representatives supplying medical device and in vitro diagnostic product in the EU market. Companies will need to implement many new or enhanced capabilities to meet these obligations.
For companies faced with these challenges, it begs the obvious question ‘So where do we start?’
Define your strategy
The logical first step is to define the company’s strategy for how to tackle the new regulations. Typically, strategy development would include:
1. Understanding of the current and new legislation.
2. Impact of the legislation on the company’s operations, including any opportunities that might present.
3. A gap analysis of each relevant aspect of the company’s operations against the requirements of the new legislation.
4. An assessment on existing and pipeline product registrations, testing and labelling.
5. Initial high level designs of potential new processes, capabilities and IT solutions.
6. High level roadmap for re-registrations, testing or re-labelling and implementing new processes, capabilities and IT solutions.
7. Cost and resource impact estimation.
8. Plan for the next phase of activity.
Some considerations when defining your strategy
From our experience of delivering large and complex legislative-driven change, there are a number of things to think about when defining your strategy:
Take a cross functional approach: The impacts of the regulations are cross-functional so make sure that you have all relevant functions involved in defining your strategy. Avoid the temptation to ‘slice and dice’, allowing each function to independently develop their approach. The company needs a holistic response so develop your strategy as a true cross-functional activity. All stakeholder groups involved in the delivery of the legislation need to contribute effectively or the whole process is at risk of failure. Therefore, all parties must buy into their roles in the processes and actively contribute to them. This will rarely happen if they are simply passive bystanders in the design of the capabilities or the delivery of the resulting activities.
Define and agree some governing principles: Providing guidance to the team on what would be permissible or not, defining the ‘rules of game’ to all parties. This provides a boundary and decision-making framework for solutions being developed and should be approved and managed by the governance team.
Ensure effective cross-functional governance: Given the cross-functional and cross-organisational nature of the regulations, establishing the right inclusive leadership and governance is key to the long-term success of the activity. A cross-function governance team should therefore be established to steer the definition, establishment and ongoing delivery of your strategy. This governance body should include membership from all the stakeholder groups involved.
Build in flexibility: The implementation of solutions to address new legislative drivers is complex, not least because through the implementation journey, the legislation evolves. Unforeseen situations and challenges will arise, timelines may change, Delegated Acts may introduce further local requirements. Therefore, solutions defined need to have sufficient flexibility to cope with further emerging requirements. This is not easy, but is a key challenge of which solution design teams must be made aware.
Look for standard approaches: In large and complex operations, it may be necessary to implement solutions at multiple locations. It can therefore be beneficial to develop standard approaches for solutions that can be replicated at each of these locations rather than ‘re-inventing the wheel’ at each one. This provides two benefits – it can be more efficient in preparing the solutions and learnings across the organisation can be shared. However, if taking this approach, local requirements must be highlighted and built into the developed solutions.
Put a capable, dynamic and motivated leader on the problem: These regulations are complex and evolving, touching many parts of an organisation. With the challenges facing the leadership that is charged with implementing such capabilities, they need to have a broad range of skills, the drive and motivation to anticipate risks and issues, as well as ensure they are effectively managed proactively. Furthermore, there will be many technical challenges to address so the leadership of the program needs to have the technical strength and breadth to succeed in managing these.
Involve local country teams and management early: Good change management practice encourages the involvement of those impacted early in the activity. The local country teams will be key in supporting implementation and ongoing operation of solutions implemented, as well as undertaking a significant role in product re-registration and labelling updates. Involving them early will ensure solutions are fit for purpose and that they buy into the activities you need them to do.
Refresh your strategy as appropriate: The implementation of the new regulations will take many years and requirements will probably evolve. The environment you operate in and your company will likely change in this time as well. Your strategy is therefore not a one-time activity. It needs to grow and evolve as the surroundings change. Hence you need to build in regular reviews of the strategy to ensure it remains pertinent and comprehensive.
Your strategy will help you chart your course
As can be seen from the above, developing your strategy is a key point in your journey to address the issues presented by EU MDR/EU IVDR. It will help your company understand what needs to be done and how resources will be marshalled to address those challenges. The strategy processes need to be timely, giving enough time to undertake the strategy process itself effectively but also giving enough time to subsequently implement the new requirements, and it is an ongoing process tuning the company’s response as situations change. Appropriate flexibility and risk mitigation needs to be built into your solutions and deployment plans. A good strategy will help facilitate a successful response to the legislation across your organisation.
If you are impacted by EU MDR / IVDR, start planning how to transition to the new requirements and avoid supply interruptions. Our Executive Briefing, An Introduction to the EU Medical Device Regulation (EU MDR) can help you understand the legislation and develop a strategy for transition.
Should you have any questions about this or any of my other blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.