Hi again! This week I am switching it up a bit, and look at medical devices, particularly the EU regulation for medical devices (MDR) that came into force one year ago.
New regulation for medical devices (MDR)
Since 26 May 2021, manufacturers have to follow the new EU regulation for medical devices (MDR), which included a reform for the certification of medical devices.
This new MDR replaced the existing processes for the launch and supply of medical devices that were established over decades.
Impact of MDR on existing medical devices
The EU MDR means that an estimated 55,000 medical devices that are already on the German market have to be re-certified by 26 May 2024. But this re-certification often requires clinical data that have never been collected.
Therefore, the medical device industry and medical societies warn that these re-certification requirements lead to supply shortages and withdrawals:
- Sometimes the effort and costs of gathering the missing data are too high, so manufacturers withdraw their products from the German market or limit their product portfolio. Particularly for niche products, the small number of medical devices sold in Germany does not compensate the effort of re-certification. The withdrawals can lead to supply shortages, especially for specific patient groups, such as children, where there are no available alternatives.
- In addition, the withdrawal of niche products might also lead to an increased use of unlicensed products.
- A survey of 378 manufacturers of medical devices showed that many manufacturers already have withdrawn some products now, and that others will disappear from the German market by 2024 at the latest. This was consistent across all 21 therapy areas in the survey. At least half of the manufacturers will remove specific products, whole product groups, or the complete portfolio, e.g. in orthopaedics or classic surgical instruments.
- In alignment with this, the BVMed also thinks that the transitional period is too short and that the agencies could not re-certify all existing medical devices by the deadline of 26 May 2024. They estimated that about 30% of medical devices would disappear from the German market.
Impact of MDR on certification agencies = Notified bodies
With the EU MDR, the certifications of new and re-certifications of existing medical devices are conducted by so-called “notified bodies”. Previously, there were 58 notified bodies in Germany that have issued 25,000 (AI)MDD certifications over five years.
However, with the MDR, all existing notified bodies first also have to be re-certified. Only 28 notified bodies in Germany have been certified under the MDR so far; the assessment of another 56 is still ongoing. If the certification of notified bodies continues at the same speed, only 48 will be certified by May 2024.
In addition, the staff of the notified bodies needs training on the new requirements according to the MDR. Because of the high demand for more staff, half of them have only 2 years or less experience with certifications.
The certification with the notified bodies also resulted in a doubling of costs for manufacturers, as well as much longer (more than double) assessment durations. This immensely delays the patients’ access to new devices.
Overall, there are fewer notified bodies, and fewer trained resources within them, while there is a higher number of products requiring more in-depths assessments for certifications in a shorter duration.
Impact of MDR on new medical devices
The MDR also negatively impacts the development of new medical devices. According to the survey, 46% of manufacturers put their innovation projects on hold. 19% are launching their products first outside of the EU, in the US or in Asia.
The BVMed and VDGH concluded that manufacturers without an assigned notified body can’t introduce a new medical device into the German market, since there is no capacity for its certification.
But there is an impact even for those manufacturer with a notified body. Because the notified bodies need to meet the deadlines for the re-certification of existing devices, they can’t certify new products.
Recommendations by the industry and AWMF
To ensure continued patient access to existing and new innovative medical devices, several industry associations and the AWMF have demanded changes to the certification requirements of the MDR.
Simpler re-certifications
- While the AWMF generally is in favour of increasing the safety of medical devices, they request to streamline re-certifications. The BfArM and BMG could apply special regulations to existing medical devices with a risk for withdrawal, and conduct the re-certification based on registry data. These existing registry data would easily show whether there were any safety concerns with the products in the past.
- Likewise, industry associations have requested to maintain all existing certifications and to simplify their assessments.
- The BVMed suggested to extend the deadline for re-certifications. In addition, they proposed that joint assessments for (re-)certifications should be sped up.
More notified bodies
The current number of certified notified bodies can not cover the amount of re-certifications required with the MDR. Therefore, the burden on the notified bodies needs to be minimized.
- The BVMed, VDGH and industry associations request to expand the number and capacities of the notified bodies.
- Moreover, there should be incentives for new applicants to become certified notified bodies.
- Lastly, all manufacturers should have equal access to notified bodies.
Faster certification of new devices
- The AWMF wants to introduce a gradual, faster certification for innovative medical devices, since the demand for re-certification of the existing products will slow the launch and certification of new innovative medical devices. This faster process would allow patient access to innovative products already before the general launch.
- This testing regulation would allow a launch under controlled conditions, while testing the products in clinical studies as well as collecting RWE through registries. This will provide quality data that the notified bodies can later use for the further approval steps.
- The registries would provide continuous, updated, data allowing a rolling review. To ensure the registry data are reliable, the participation of all involved parties should be mandatory.
- In addition, the AWMF demands that independent experts conduct checks of medical devices with safety concerns. Currently, the manufacturers themselves carry out these checks.
- Likewise, the BVMed and VDGH ask for fast-track processes for the certification of innovative medical devices.
Further reading related to medical devices
- Happy with your knowledge on the reimbursement of medical devices in Germany?
- 8 NUB assessments of high-risk medical devices (§ 137h)
- The process of method assessments in Germany
Newsletter
If you liked this post and don’t want to miss the next one, sign up for my free weekly newsletter!