When you sit down to address your gap analysis between MDD and MDR, there are a host of questions you will want to think about. This list is not expected to be comprehensive but it should be a good place to start.
What changes are needing to be for your devices?
You need to begin by comparing what the changes are for your device: what is new or different under MDR that you did not have to comply with under MDD. Once this is compiled, you should consider the regulatory impacts and how that will impact your product in the EU versus the US. Can you use the US product once you have met the regulatory standards or will you need to come out with an EU specific product?
You may need to redesign the product. You must resubmit it to FDA if you do that – or go with two models for different geographic targets.
What documentation standards will you need to meet? Will that require re-testing? More clinical studies? Or can you use post-market surveillance to meet the new documentation standards for your product?
Questions about medical devices
We are also seeing some questions about Single-Use vs. Reuse. While many devices are made to be single-use, we all know that some physicians will reuse products. Do your products need single-use limiters such as device identifiers or re-use prevention methods? This will impact product labeling, and potentially the instruction manual.
We are seeing some companies also have to re-certify their supply chain to demonstrate complete traceability and documentation for their Notified Body.
Speaking of your Notified Body, there are a number of issues to address in your Gap Analysis regarding the Notified Body: Where are you in their Queue? Are they even still in business? Have they notified you or have a transition plan? Will they be a Notified Body when you are ready to re-certify? How is your Notified Body prioritizing you over other clients? The number of Notified Bodies has dropped dramatically in recent years.
Contact The Waddell Group
From Start-ups to Fortune 100 companies 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. If your in need of help with a gap analysis or regulations of a medical device our team can help. Contact The Waddell Group today and call 952.221.3333