Thomas is an expert in Supply Chain and Manufacturing Optimization with more than 10 years of experience originating from Medical Device and High-Tech & Electronic Industries. He comes with a background as an Electronics engineer, complemented with a Master in Technology Management. Thomas has held positions in multinational corporations such as Nilfisk, heading the internal optimization program as well as the supply chain organization.
The lack of Notified Bodies puts medical device companies at risk of missing compliance deadline with EU MDR
With only a year before the EU MDR regulatory changes are fully implemented, the list over available Notified Bodies shows an alarming number: Less than 10 Notified Body has obtained their re-designation to start this huge task of recertificating medical devices so they can be sold on European soil.
This high-risk situation remains the European medical device industry’s highest concern, according to the trade organization, MedTech Europe.
And according to the industry expert, Christoph Manegold, this situation poses a great safety risk in the European healthcare sector. Without such re-certification, medical devices cannot continue to be made available to hospitals, healthcare professionals and patients.
"The problems for the industry is the lack of Notified Bodies, the availability of them has dropped dramatically. The competition against Notified Bodies is going to shrink because the new regulatory changes are forcing Notified Bodies to be re-designated," says Christoph Manegold and continues:
"And as the industry is depending on Notified Bodies for auditing and product certification to release products on the market, this problem is already very evident and a burden on the entire medical device industry in Europe," says Christoph Manegold.
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More needed than ever before
The new MDR requires companies to re-certify their medical device product under the new standard if they want to keep selling them in Europe. However, to get this done, available Notified Bodies are needed with enough capacity to undergo the vast amount of re-certification procedures by May 2020. And these valuable resources are more limited now than they have ever been before.
"Just a few years ago, we had around 84 Notified Bodies in Europe alone. Meanwhile, we are now below 50, and many of these have not been re-designated yet," says Christoph Manegold.
Need to undergo lengthy re-designation process
A key contributing factor to the challenge is that Notified Bodies must go through a lengthy, formal process to be certified by European Union officials. At this point, very few have been through that process, compounding the scarcity of resources.
"The issue with Notified Bodies now is that they have not got time to deal with customers because they are too busy with their own tasks. If you do not get a clearance, you cannot update nor sell your product, and that has an immediate impact on your balance sheet," says Christoph Manegold.
This makes it difficult for medical device companies who are trying to be proactive about meeting MDR requirements in 2019 and beyond. There is only so much they can do when the necessary resources are not available.
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The “Grace period” will save some, but far from enough
Because the new medical device regulatory changes include a ‘grace period' mechanism, it allows for certain medical devices to be re-certified under the current medical devices' directives with the certificates valid up to 2024. However, this ‘safeguard' measure does not provide a system-wide solution and will not be able to solve the described re-certification bottleneck.
This is concerning because, with only a few Notified Bodies who are up to speed and have the availability, it will be challenging for medical device companies to be compliant with the new regulations.
"The consequence is that smaller companies will have to shuffle their resources away from R&D into regulatory and quality – away from innovation and into administration and companies don't like that. This is, in a nutshell, a part of the burden that the industry is facing," says Christoph Manegold.
About Christoph R. Manegold:
Christoph Manegold is CEO of Nano4Imaging, a German-based MedTech company that specializes in diagnostics and interventions for MRI. He is the initiator of the federal network MDR Competence and a frequent commentator on the upcoming EU MDR regulatory changes.
About the EU MDR:
Due to severe patient incidents with medical device products in Europe, including the hip replacement and breast implant scandals, there have been frequent calls for tighter regulation with medical device products in Europe. That has led to the Medical Devices Regulation (EU MDR), which took effect on 25th May 2017 and after a three-year transition period, will become mandatory in all EU member states.