Introduction
All procedures in gastrointestinal (GI) endoscopy are dependent on medical devices.
This includes endoscopes and processors, water, suction, and CO2 pumps, and a large variety of disposable devices such as snares, knives, biopsy forceps,
stents, ligation bands, clips, and needles. Without proper and immediate access to
these devices, the field of GI endoscopy would not be able to function in its entirety.
The European Union (EU) introduced stricter rules and regulations for the approval
of medical devices in their new Medical Device Regulation (MDR), which became effective
in May 2021 [1 ]. The MDR includes a transition period in which devices approved under the previous
EU legislation (the Medical Device Directive [MDD]) need to be re-certified. This
transition period was originally scheduled to expire in May 2024; in January 2023,
the EU commission extended the transition period until December 2027 or December 2028,
depending on the device risk class.
After these deadlines, all medical devices in Europe, current and new ones, will require
certification under the new stricter rules. Devices that are not re-certified or do
not meet the bar under the new rules will no longer be available for endoscopists
in Europe. This will have far-reaching consequences for both endoscopists, patients,
and healthcare systems.
This ESGE position paper summarizes the new requirements, discusses its implications,
and aims to raise awareness of the challenges and opportunities for endoscopy services
in the EU.
From old to new legislation
Under the old MDD legislation, a detailed assessment of the balance of clinical benefits
versus potential harms was not required for many devices. The old legislation basically
ensured that a medical device had the material qualities as described by the manufacturer.
For many devices, manufacturers simply had to prove that a device made from plastic
with a component of metal was indeed made of the designated components. The new EU
MDR is profoundly changing this paradigm [2 ].
The European Parliament has passed the new MDR, which is applicable to all EU member
countries and in the EU-affiliated countries Iceland, Liechtenstein, and Norway [1 ]. It replaces two previous laws, namely the MDD and the Directive on Active Implantable
Medical Devices (AIMD). The new MDR is different from the previous legislation in
the following areas of importance for endoscopists and patients.
Requirements for clinical benefit of endoscopic devices
Manufacturers of all endoscopic devices that are currently in clinical use must re-certify
their devices under these stricter rules by 2027/2028. New devices entering the market
from now on will be scrutinized more closely regarding their clinical benefits and
patient harm, applying the new stricter legislation. Additionally, the MDR requests
that manufacturers monitor the performance of their devices after marketing, called
“post-marketing clinical follow-up (PMCF),” for the entire time a device is on the
European market.
The bar for proof of clinical benefit is being raised most for devices in the highest
risk classes (risk classes IIb and III). As a rule of thumb, devices that remain in
the body for up to 30 days are class IIa, and those remaining longer than 30 days
are class IIb [1 ]. Endoscopists use many IIa and IIb devices, such as biliary, enteral, or colonic
stents, and full-thickness resection devices. Class III devices are not as common
in endoscopy; these include devices in the central circulatory or nervous system,
and all devices containing a drug or active compound (such as drug-eluting stents).
The MDR also defines endoscopic artificial intelligence (AI) products aiding endoscopists
to make diagnostic or therapeutic decisions as medical devices. This includes computer-aided
detection (CADe) and computer-aided diagnosis (CADx) tools in endoscopy. Separate
legislation, the so-called “AI Act,” is planned by the EU to further define the future
requirements related to computer algorithms and data security.
The ESGE expects that the new MDR will increase the need for clinical trials and observational
studies for endoscopic devices in Europe. The ESGE will actively prepare European
endoscopy environments to facilitate opportunities for more and better industry-sponsored
clinical trials and registry studies to meet the demand for more robust data for endoscopic
devices in the European market with “clinically relevant end points,” as required
in the new MDR [1 ].
EU expert panel for endoscopy devices
The EU is currently establishing “independent expert panels” for device regulation
in many areas of medicine. One of these expert panels has been established for “gastroenterology
and hepatology,” including endoscopy [3 ]. These panels have between two and more than 30 members. The gastroenterology and
hepatology panel has five members as of February 2023 [3 ].
The gastroenterology and hepatology panel will be responsible for the assessment of
endoscopy devices, in liaison with the device companies who apply for certification
and the notified bodies, who certify devices on behalf of the EU.
The MDR requires that expert panels provide scientific guidance relating to clinical
studies and relevant end points, patient numbers, and clinical development strategies.
The panel also assesses the results of the requested clinical studies for device approval.
The involvement of expert panels is explicitly required for devices in classes IIb
and III.
Panel members are appointed by the European Commission based on clinical, scientific,
or technical expertise. Experts may apply for panel membership directly to the EU
through a dedicated web portal. Experts need to be citizens of an EU or EU-affiliated
country, and should not have any conflicts of interest (e. g. collaboration or consultancy
with the medical device industry) [3 ].
The ESGE encourages members with expertise in the testing of technical and clinical
performance of endoscopic devices to apply for membership of the EU gastroenterology
expert panel. The ESGE provides information for interested endoscopists on the ESGE
website.
EU notified bodies
The EU has charged private companies with the handling of all aspects of device testing,
including final approval for marketing. These companies are called notified bodies
and have expertise in device testing, clinical trials, and regulatory processes. Currently,
36 companies in different European countries are approved by the EU as notified bodies
[4 ].
Notified bodies communicate with device manufacturers and with the expert panels about
the appropriate level of testing required for each device to be compliant with the
MDR. Details for preclinical and clinical testing, including study design, study end
points, and the number of patients needed to test the device before market approval,
are negotiated between the three parties. After fulfilment of the requirements, the
notified body grants marketing approval for the device and the manufacturer can start
selling the device to endoscopy practices across Europe.
The ESGE will facilitate the three-party process of endoscopy device approval and
will actively engage with notified bodies on topics relating to the new endoscopy
device approval process.
Challenges and opportunities
These new regulations are challenging for many device manufacturers. The increased
requirements for scientific studies and clinical trials increase the costs for device
development and premarket approval. The process for device approval and maintenance
of certification is time-consuming and resource intensive. Revenue margins will be
challenged and, in turn, device costs for customers may increase significantly. This
may be particularly true for small device manufacturers and start-up companies, who
may find it difficult to raise funding to adhere to the stricter rules for device
documentation and clinical testing.
A recent survey of the medical device industry in Europe showed that some device manufacturers
are already reducing their activities around new devices and have stopped lines of
development for new endoscopy equipment [5 ]. Some companies also report that they will withdraw their currently used endoscopy
devices from the European market because they consider the re-certification process
required by the new MDR to be too costly, time-consuming, and bureaucratic. So far,
only about 15 % of all medical devices currently used in Europe have been re-certified
under the new MDR [5 ].
In December 2022, the ESGE conducted an online survey investigating the status and
prospects of the endoscopic device industry in Europe. The survey was sent to representatives
of 15 companies and 10 replied. [Fig. 1 ] shows that companies that replied expect to spend more money and resources on device
certification and engage in more clinical device trials in the years to come. Of concern,
more than half of the companies are considering withdrawing or have already withdrawn
endoscopic devices from the European market because of the new MDR, and 60 % of companies
will be reducing the number of devices that they would normally send for market approval
in the future.
Fig. 1 Results of a survey of endoscopy device companies in Europe about the introduction
of the European Union Medical Device Regulation (MDR) with regard to: a money and resources they expect to spend; b future trial sponsorship plans; c withdrawal of devices from the European market; d possible plans to reduce the number of new devices being submitted for certification.
The survey was conducted as an anonymous web questionnaire in December 2022. It was
sent to representatives of 15 companies and 10 replied.
The notified bodies and the EU expert panels have important roles under the new legislation.
Major challenges include a lack of capacity at the notified bodies and the strict
rules regarding conflicts of interest for experts, which may be difficult to apply
because many experts are involved in the evaluation of medical devices together with
the device manufacturers. These and other challenges may have forced the EU in the
latter part of 2022 to realize that the original deadline for device transition in
May 2024 would threaten access to important medical devices in Europe and jeopardize
the quality of European healthcare. The recent extension of transition deadlines until
2027 or 2028 (depending on device class) will help notified bodies, clinical experts,
and manufacturers to adjust to these new rules. There is however a large backlog for
the re-certification of devices and it may not be realistic to re-certify all available
devices, even by 2027/2028. Therefore, the GI endoscopy community needs to work efficiently
to prepare and establish systems for proper device testing under the new EU legislation.
The ESGE will facilitate the establishment of such systems and support industry, GI
endoscopists, notified bodies, and patients to ensure continued access to high quality
endoscopy practice in the future.
