The European Union (EU) is set to shift the regulatory structure of medical devices from MDD to MDR compliance. Simply put, Class II, Class III, and other high-risk medical devices are going to require recertification under a new set of rules to remain on the market. The EU will not allow any devices to be grandfathered in. When your existing certification ends, you will be required to make sure you are in compliance. If this is not taken care of, your products may go off the market in Europe.
If your business has products that need recertification, the three big questions you need to ask are:
- What devices are a priority?
- Have you performed a gap analysis?
- How long will it take to re-certify?
Class II and Class III Medical Devices
Prioritizing your Class II, Class III, and other high-risk medical devices are vital. You will need to assess how much European revenue and profit you garner from any one device to determine when to re-certify. Be sure to take into account that some devices are reliant on the existence and implementation of other devices and that some devices might take longer to get re-certified than others will.
Performing a gap analysis of your products is a necessary step as it will provide you with an idea of the scope of the recertification process. This will allow you to construct a plan to assure that recertification happens on time and on budget.
Getting an accurate time frame is key in this process. With the expected reduction of the number of Notified Bodies in Europe, there will be a backlog. You need to get started as early as you can to make sure you re-certify inside the required window.
As leaders in Medical Device Manufacturing Project Management services, the Waddell Group has the experience and team to help you and your company through the recertification process.
Prioritize your regulatory structure. Contact us to schedule a review of your recertification needs today!
Get in Touch and contact the Waddell Group today. We provide strategic level project leaders for the medical device industry. Beyond essential project management skills, our highly experienced consultants know how to lead teams, manage in times of crisis, and influence change. We offer expertise, intellectual property, and proven methodology. Let us be your experts when it comes to the EU regulation certifications, call or contact us at (952) 221-3333 today