At long last, the date has arrived. Organisations who aspire to be Notified Bodies under the European IVD and medical devices regulations can submit their applications as of yesterday, 26 November 2017. In order for the new regulatory system to function as intended, it is essential that these assessment bodies be up-and-running as early as possible. This will impact a vast majority of the 500,000 medtech products already on the market as well as new ones. It includes in particular, IVDs, which need Notified Body oversight for the first time.
What happens next?
Applications are open. The application forms and the necessary Implementing Act were all published on-time. Organisations who apply will be treated on a “first come, first served” basis. Their applications receive a completeness check and preliminary review by their responsible national authority, and if all is in order they undergo an on-site audit.
This process is called a “joint assessment,” because it involves both the European Commission and experts from at least three different national authorities. On-site visits, phone calls, paper reviews and more all happen to confirm that the organisations have the necessary competence and expertise to check the safety and performance of IVDs and medical devices. When that happens successfully, the respective national designating authorities will give these organisations their license to operate as Notified Bodies in the IVD or medical devices field.
Who is applying?
Demand for Notified Bodies in this sector is at an all-time high, and is expected to increase substantially, especially for IVDs. The vast majority of our existing Notified Bodies are therefore expected to apply to remain Notified Bodies under the new Regulations. We also expect that new players will seek to enter this space in the future, though some longstanding Notified Bodies may cease to exist.
Many well-established Notified Bodies for IVDs and medical devices intend to apply very early. For instance, Team-NB states that 84% of their members will have applied by the end of this month (92% by the end of the year!).
Although authorities aren’t disclosing the specific organizations that have applied, individual applicant Notified Bodies are free to make this known, and to tell the manufacturers with whom they work and how far along in the process their applications are. So if you are an IVD or medical device manufacturer and already have a Notified Body, ask to be kept informed!
When will they become available?
The million-dollar question! The speed at which an organisation passes their joint assessment depends on how early they apply, how good their application is, how competent and qualified they are, and so on. It also depends on the availability of European Commission and the joint audit team and how ambitious the authorities are in making the process go quickly.
Authorities currently estimate that 18 months are needed on-average, from the time an organisation applies to the time it is designated as a Notified Body under the new regulations. This suggests that the first Notified Bodies may only become available from mid-2019. Given that mid-2020 is the final compliance deadline for the medical devices regulation, MedTech Europe fears this will be a case of “too little, too late.”
What does it all mean?
To make a success of the regulations, the medtech industry needs Notified Bodies to be available and up-and-running as early as possible, for both IVDs and medical devices and for all applicable fields of technologies. Without this, the system faces a serious risk of “bottlenecking,” i.e., too many medtech products under review simultaneously, with Notified Bodies having too little time and too little bandwidth.
This scenario concerns us all. It certainly concerns manufacturers, who fear the system will only be able to process a fraction of the many hundreds of thousands of IVDs and medical devices out there. It should also concern patients, doctors, laboratories and hospitals that rely on these products, especially if some products can no longer be supplied.
Authorities and the European Commission can do much to address this scenario. They can ensure that enough experts are made available to conduct multiple simultaneous joint assessments. They can endeavour to work quickly to designate Notified Bodies under the new regulations as early as possible (far earlier than mid-2019!).
MedTech Europe is fully committed to working with all authorities to devise solutions to this challenging situation. Let’s inject some certainty and predictability into the coming months. We all need to make a success of the next steps, and that requires a clear plan, investment of resources, and a whole lot of ambition.
I would wish us all Good Luck! by saying “in bocca al lupo” (Italian for “into the mouth of the wolf”) but that would be too ominous. Besides, no truly workable regulatory system should need luck to succeed.
Let’s instead work together, to make our own luck.