This morning the Dutch financial newspaper FD published a full front-page article on the upcoming MedTech crisis that will hit Dutch healthcare providers on May 26 2020. The story continues further down the paper with a second full page.
The article is clear in identifying that we have come to a very crucial moment, where complexities involving market approval enhancements are potentially leading to unavailability of healthcare products, both medical devices and in-vitro diagnostics. And clearly the authorities identify rescue measures that are in place for critical care, but obviously not all products could easily be supported by the emergency ruling.
Parties are pointing to each other. Notified bodies indicate manufacturers are not yet ready, hospitals indicate manufacturers and distributors are not clearly identifying which products will not be available anymore after the deadline. But the reality is much more complex. Hospitals in their tender/procurement processes typically request CE certificates of conformities, which indicate how long after the deadline the products can still be marketed in the EU. No guarantees, but a good sign on length of the availability period. The central EU database that will provide a clear oversight on such product status moving forward has been delayed in its introduction.
So, what nobody seems to place at the front is why we have such a delay in the designation of the Notified Bodies. At the start of the transition period, they could not yet apply for 6 months, until rules of designation were written down. And with broad stakeholder elements in the approval process, joint authority audits to be scheduled, auditors to be trained, centralised review of designation recommendation etc., the whole process of getting designated is easily eating 2 years. Hence, we saw the first designations coming to light a rough half year before the end of the transition period. No surprises there, as that was the process being built.
The transition period has been built in three phases, taking a total of 8 years. We’re only in the first 3-year phase, after which we will have a 4-year period where products with valid certificates for the current legislation can continue to be placed on the market, followed by a final year of selling all residual stock from distribution warehouses.
Two core challenges are at the forefront until May 2020: the low-risk products that do not need a certificate need to be compliant to the new medical device law at the end of the first period. And most prominently, there is a backlog in getting existing certificate renewed before the final deadline of issuing renewed certificates under the old legislation (May 25 2020). As the Notified Bodies are largely prioritizing this ability for manufacturers to move into the second transition phase (4-year grace period), we logically do not see many new certificates under the new MDR legislation being published. That will start changing after the deadline, as then all focus will move to the new legislation.
More Notified Bodies are expected to be assigned in the next few months. The current number is 10, but they include some of the largest test houses. Together the designated Notified Bodies are responsible for the vast majority of currently issued medical devices certificates.
So, we have a resource crunch for sure, but there is no need at this stage to book your next surgery outside of EU.
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