By May 2020, the new European Union Medical Device Regulation (EU MDR) will be fully implemented. Medical device manufacturers now need to comply with a set of new and critically important regulations. While this deadline is fast arriving, there is still time to plan ahead. To make that planning as effective as possible, there are several key approaches your organization should think about taking.
Familiarize Yourself with the New Regulation
When planning ahead for the EU MDR, the first thing your organization needs to do is go through the regulation in full. While this seems self-evident, it’s an activity that can sometimes get overlooked. By investing the time in understanding the regulation, you can put your teams in a much better position to transition your existing quality systems into EU-compliant ones.
This involves two major steps: learning the new MDR regulations and translating them into actionable requirements. Your regulatory personnel should go through the MDR and identify what regulations apply to your life science company. Then, working with your management and quality teams, translate those regulations into requirements your organization can realistically fulfill and incorporate into your QMS.
Conduct Gap Analysis
There are numerous ways to proceed with the EU MDR transition after familiarizing yourself with the regulation. One method you can use is leveraging tools such as gap analysis. With these sorts of tools, you can pinpoint your current level of preparedness, available resources, and the steps needed to get to full compliance. Looking at these steps against the available timeline—full EU MDR implementation is set for May 2020—you can then prioritize tasks based on need and importance.
Using tools like gap analysis leads to perhaps the most important step of the planning process: instituting your implementation plan. When constructing this plan, it’s important to note:
- Top-priority tasks
- Roles and responsibilities
- Timelines for task completion
- Resource allocations and needs
By addressing these concerns in your implementation plan, you can provide your teams with a clear picture of how to proceed once the implementation plan is established. Your team needs clarity to get from their current state to full MDR compliance. The more thorough your plan is, the easier your compliance activities become.
Evaluate Potential Risks
Your organization needs a robust transition plan in place to ensure compliance with the EU MDR regulations. While understanding the new requirements and conducting gap analysis allow you to develop a well-informed plan, there are also other issues that need to be considered. In particular, any shift in your QMS can carry with it risks that need to be controlled.
Before, during, and after the transition to the MDR, your organization should evaluate and monitor any prospective impacts to your QMS. This helps you detect and analyze any risks this new EU regulatory scheme could have on your organization. After controlling these risks, you can incorporate the resulting mitigations and MDR requirements into your QMS.
Identifying the risks of regulatory transitions doesn’t cross the minds of many organizations, but they are important to factor in when planning ahead. The earlier you can manage them, in conjunction with completing other planning steps, the more effective your transition to the EU MDR can be.
