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.