For the last 5 years Medical Device companies have worried about the impact of the new Medical Device Regulations on their business, and what would happen May 26th, 2020, when the new law would be implemented within the EU. Then, when COVID hit, and implementation of the law was delayed with a year, companies got a welcome reprieve.
Impact has been described as severe. Companies would withdraw products from the market, given that costs to pass and maintain regulatory approval would increase significantly. Furthermore, as the EU outsources the certification of Medical Devices to third party Notified Bodies, they themselves had to be newly designated under the new law. These new Notified Bodies did not materialize as fast as most hoped for, and a bottleneck was said to be inevitable. Further holding up approval was lack of clarity and guidance surrounding some of the requirements of the new law. These guidances were slow coming causing anxiety amongst the affected parties. Lastly, a new EU database of industry players, products, and adverse events, while promised to be ready for launch when the law was originally to come into effect, was significantly delayed.
Tomorrow is May 26, 2021 and MDR will come into effect. MDD and AIMDD are no more. Some CE marks, issued under the old Directives are carried over during a transitionary period but will start to phase out over the next few years.
Most of the issues mentioned above will fade over time: market forces will help erase the bottleneck at the Notified Body level, additional guidance will appear and eventually EUDAMED will be fully functional.
What will remain is the added cost and time needed to bring products to market within the EU.
With a higher up-front investment, it becomes even more important that companies think through the economics of the business they are in. Who will buy the device? Who will pay for it? And how much? Within the EU these questions are not easily answered. But a company interested in growing or selling itself to an interested partner better have good answers to these questions.
The IVDR comes into effect next year, May 26th, 2021. For IVD companies the above issues are the same, but much more pronounced. As only 20% of IVD’s needed to pass Notified Body scrutiny under IVDD, 80% will need to do so under IVDR. Besides only 5 NB’s have been designated under IVDR.
For IVD’s as well, eventually all the bottlenecks and problems will get sorted. What will remain are the economic questions. Who pays, why would they, and how much will they be willing to pay?