The stakes seem high and the risk is real, but in a very large sense executing your MDR project is just another project. This is the fifth blog post in a serious on the changing European regulations in Europe. The previous four discussed what MDR is and why it is a concern, how to prioritize your devices in preparation for the new regulations, what to be thinking about as you perform a gap analysis, and finally, how to build a plan.
A normal development project will typically have five phases, from 1) concept, through 2) development, to 3) design and process validation, and any sort of 4) product validation before you submit. Once you have approval, you 5) launch and do post-market surveillance. The shift from MDD to MDR has a few variations, but they stay consistent with these five phases.
First, return to your Gap Analysis. Do you have to redesign your product? Is there additional testing required? Or do you have to just provide more documentation? The process is the same – but it is a question of how to make that happen.
Next, revisit your Risk Analysis. Are there potential design changes to be made? If you have to do new clinical trials, are there any unexpected results to consider as a contingency? It may cause you to rethink the plan to include the corrections. Are there new risks to mitigate, or are those risks justifiable in light of the modifications to the product?
One significant change is more cultural than procedural: How you work with your Notified Body. Notified Bodies were always considered an advocate to the industry. Now there is more emphasis that they confirm that regulations are being fulfilled – more auditing and policing. They have more clout. And while in the past, they may have worked with you to get your product to market, this is no longer expected to be the case. Just as you are being held more accountable, they are also being held more accountable and they will be very busy.
Back to the main theme: this is just another project; an important one, to be sure. Put good people on it and project manage the heck out of it.
This is the fourth blog post in a series on the changing European regulations in Europe. The previous three outlined what MDR is and why it is a concern, how to prioritize your devices in prep for the new regulations, and what to be thinking about as you perform a gap analysis.
This blog post concentrates on how to build a plan of action. If you need a refresher, please see the other posts or reach out to us and we can discuss how these apply to you. They are important as you must prioritize each device as well as understand the gap between where you are and where you need to be before you can create a plan to get on track to compliance.
There are four key elements to getting a plan completed: You need good planning, accurate budgeting, smart resource management and someone who will captain the ship (or Program Leadership).
Your plan must be sufficiently detailed to cover what your resources are going to be doing, with clear milestones along the way to measure progress and to create predictability to complete the project on time and on budget. This presents a great place for a strong project manager to meet/exceed your expectations. When you have done the gap analysis, you should identify how long it will take for this project to be completed. If it is a six-month project, you may wish to outsource the project to a team like Waddell Group. If it is a multi-year project, you may wish to use in house talent or permanent employees.
You must also review your budget for this project. Where will the money come from? Odds are that you might be putting other projects on hold so that you can make sure your products stay on the market in Europe. In an earlier blog post, we discussed prioritizing your devices to get through MDR (and/or IVDR). Something similar might take place here where you weigh prioritization of products on the market vs. those you are working to get to market. What makes some projects higher priority than others?
Resource management is going to be key. As with any project, you have to know who you need (required skill set), when you need them, and how long you can keep them. Managing human capital along a timeline will be critical to getting your products compliant with MDR for your Notified Bodies.
Finally, you need strong project management. Because of the stakes for your company– your plan has to be credible, the plan must be executed on time and within budget, and you need experts who can manage all of your talented staff to this necessary end.
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.
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 a 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?
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 labelling, and potentially the instruction manual.
We are seeing some companies also have to recertify 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 recertify? How is your Notified Body prioritizing you over other clients? The number of Notified Bodies has dropped dramatically in recent years.
When you are creating a priority list for your Class II and III Medical Devices, you need to take many things into consideration. Most people look for the simple answer: How much revenue and profit is generated in Europe by my list of products? This can be a good litmus test, and might even be the right one for you. But we encourage you to take a step back and look at the bigger picture.
You should ask yourself what the impact is of each of your products going off the market in Europe. When we look at that question, we tend to see what products are inter-dependent on each other (e.g. accessory kits and/or tools), what products open the European market to other products, and how your company generates revenue in Europe.
Do you have products that require the existence of other products to work? If that is the case, that might move both of those higher up your priority list. If you make significant revenue, but not profit from those products, that might lower their prioritization.
Another factor important in prioritization is determining how long your time frame is for getting each of your products recertified. The variables in managing the group of products getting recertified will also shuffle the list. If you have one product that won’t take very long to get recertified, then you might prioritize ones that will take longer.
However – and this was said in the introductory blog post about MDR: the reduction of Notified Bodies will impact the recertification process and will almost certainly stretch out the time it will take to get your devices up to the new MDR (no longer MDD) standards.
Finally, you should assess what other regulatory issues exist that will come into play and how that will impact your profits, timeline and prioritization.
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 recertify?
Prioritizing your Class II, Class III, and other high-risk medical devices is vital. You will need to assess how much European revenue and profit you garner from any one device to determine when to recertify. 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 recertified than others will.
Performing a gap analysis on 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 recertify 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.
Contact us to schedule a review of your recertification needs today!