Clinical Evaluation
Summary
Safety, efficacy, performance, and consistency can be considered cornerstones of what has
become expected of medical devices in more recent years, born out of multiple safety breaches,
leading to poor patient outcomes. This shone the light of scrutiny on how well medical devices
were being assessed, leading to a shift in how devices are regulated. The new way of doing
things has posed some unexpected challenges, combined with ever present financial and
political constraints faced by the industry.
At Russell Regulatory Consultants, we are constantly striving to innovate, communicate and
generally improve the way we can help our clients achieve device conformity, ultimately leading
to improved patient safety outcomes. Adopting this focus, led us to consider a key aspect of
medical device regulation, clinical evaluation. Often underappreciated and underestimated, it can
present many challenges to manufacturers, with which we are always happy to assist. But as is
our way, we want to make things better. On consideration of all the ‘major players’ in the
medical device industry, we believe bringing us all closer together is the way forward. This white
paper will consider clinical evaluation and all that it incorporates, the benefits and negatives to
having it and our suggestion for progression.
The EU MDR 2017/745 refers to clinical evaluation as a “systematic and planned process to
continuously generate, collect, analyse and assess the clinical data pertaining to a device in
order to verify the safety and performance, including clinical benefits, of the device when used
as intended by the manufacturer”. MEDDEV 2.7/1 rev 4 describes clinical evaluation as “a
methodologically sound ongoing procedure to collect, appraise and analyse clinical data
pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to
confirm compliance with relevant essential requirements for safety and performance when using
the device according to the manufacturer’s Instructions for Use”. The MHRA advise that “clinical
data is safety and/or performance information that is generated from the use of a medical
device in humans”. The MHRA goes on to say that this data can be extracted from equivalent
devices, scientific literature reviews and “data obtained through the monitoring of medical
devices once they are on the market”.
Before the 1990s, every country in Europe had their own set of rules for evaluating the
performance and safety of medical devices. These directives were then harmonized to provide a
standardized regulatory approach to evaluating how safe and effective medical devices were. In
2007, changes to the directives at the time introduced increased expectation on clinical
evaluation and Post-Market Surveillance. It also brought a new definition of clinical data and
sought to clarify what sources of clinical data were acceptable to demonstrate compliance. It
underpinned the new idea that clinical evaluation was a practice which would be expected for all
devices and not just higher risk devices, as it had been.
However, with widely publicised medical device failures, as well as ongoing disputes based on
varied interpretation of the guidelines, it was decided that regulations, as opposed to directives,
should be developed. The Medical Device Regulation was introduced in 2017.
Following Great Britain’s exit from the European Union in 2020, GB subsequently began to
follow the UK MDR in 2022. Both regulations have similar demands in terms of clinical
evaluation and so for the purposes of this white paper and in the interests of clarity, clinical
evaluation will be discussed a general sense, with emphasis placed on collaboration of
stakeholders in the medical device industry.
Under the latest regulation, new expectations were introduced in terms of clinical data pertaining
to the safety, efficacy, and performance of all medical devices. Conducting clinical evaluation was
ultimately to ensure conformity with the general safety and performance requirements set out in
the EU MDR and the Essential Requirements of the UK MDR. Furthermore, clinical evaluation is
intended to clarify the intended purpose of the device, demonstrate how the device achieves this
intended purpose, identify the clinical benefits of said device, also demonstrating that the
perceived benefits outweigh any risks posed by the device.
✓ Having a structured system which will apply to every single device gives the patient,
user, clinician, and all concerned with the device, the knowledge and confidence that the
device has been properly evaluated and the benefits of using the device outweigh the
risks of using the device, thus allowing them to make an informed decision about device
selection.
✓ Having a standardised approach to obtaining and appraising clinical evidence allows us
to establish clear goals for our devices, with the aim of aligning them with current stateof-the-art devices and practices. It also allows us to establish links in the right areas and
makes it easier to home in on the target groups for our devices, including patient
population, related conditions/diseases, and current trends in related treatment options.
This essentially allows us to establish benchmarks for safety, performance, and benefitrisk ratio of the device.
✓ Clinical evaluation enables us to discover the benefits and risks of the device, as well as
potential occurrences, found in similar or equivalent devices. Having this knowledge is
multifaceted and ultimately powerful; it enables us to nurture the identified benefits and
find news ways in which these will serve the industry. Furthermore, it allows us to
confront the risks associated with the device, not only facilitating us in being able to
address them on our own terms, but also provides a fantastic opportunity to build
relationships with the target consumer and with time, instil trust in our device.
✓ Any claims made relating to the device can be easily evidenced and underpinned by
quality clinical data derived from clinical evaluation.
▪ Like a technical document, clinical evaluation is a live document, which requires continual
attention to retain the device’s ongoing compliance. This is largely based on post-market
surveillance activities.
▪ It is an essential component of not only gaining initial certification but also for
recertification.
▪ Many manufacturers underestimate how long it takes to undertake and complete clinical
evaluation and the subsequent report. Setting aside 3-4 months is realistic, but also
accepting that delays are inevitable, especially when so many parts are required to work
in tandem to produce a quality report. It is also worth noting that good housekeeping is
key – as with technical documentation, access to various, hopefully well-organised,
documents in a timely manner is essential for the process to run smoothly.
There is no getting around the fact that there are multiple challenges facing manufacturers when
it comes to clinical evaluation.
▪ Generating sufficient amounts of quality clinical data. It has been reported that
there can be varying expectations and requirements depending on the notified body.
This echoes the case previously, before the new regulation was introduced, when
competent authorities placed varying demands on notified bodies, who in turn, placed these on manufacturers. Interpretation of regulation, lack of regulatory expertise and
experience surely contributes to this. There are standardised guidelines available, based
on what notified bodies are looking for, which should be adhered to – having too much
information is better than not enough and will reduce the risk of non-compliance and
resubmissions, which are costly and time consuming
▪ Having the right support to navigate the regulatory landscape is fundamental. As
previously mentioned, the right regulatory experience and expertise is invaluable. It can
be expensive and time consuming to train employees to this level, so manufacturers
often look to outsource. From Russell Regulatory Consultant’s perspective, this is of
course positive. However, we believe it crucial that manufacturers engage with the right
team, in order for it to be a fruitful relationship for all involved – that being the key to
collaboration.
▪ The directives on which scrutiny of devices was previously based, in relevant
terms, was inadequate. The expectations of all stakeholders involved are higher now.
Empowerment of patients to become more involved in their own healthcare is ever
present, with this comes better understanding of conditions, treatments, and devices,
which inevitably has led to patients understandably asking more questions and striving
for higher quality care and outcomes. As are clinicians, who are at the forefront of clinical
advancement and very much a part of the useful discussions surrounding it.
▪ Clinical evaluation is a double-edged sword. It stands to reason that demanding
higher quality, safer, more clinically sophisticated devices is the best outcome for all
involved. However, keeping up with those demands is proving to be a challenge for
many. Increased legislation led to scrutiny being placed on the notified bodies tasked
with ensuring manufacturers adhered to the new rules. Many notified bodies buckled
under this additional pressure, which then led to a lack of notified bodies, driving up
submission to certification times for medical device companies. This has meant many
global companies are re-evaluating where is best to sell their device. Europe was
historically the first place to go, with the more expensive and complex FDA submission
achieved in time. Now the roles are reversing, and Europe is losing out to America in
attracting manufacturers. Inevitably, this has led to a reduced number of devices being
available for use, threatening to create shortages, leading to negative effects on patient
outcomes. Many are saying this is already happening and plainly put, patients are dying
due to reduced access to devices. This is something which may only become truly
apparent with the benefit of time having passed, which is not reassuring for those
invested in our current medical device climate.
▪ Things may get worse before they get better. With faltering medical device
exposure, the quality of data which can be obtained will inevitably reduce and this will
make it more difficult to attract research and development and investment opportunities
to European countries.
This is compounded in the UK where, following Brexit, and under the UK MDR, devices
are required to evidence how they adhere to Essential Requirements, as opposed to the
General Safety and Performance Requirements of the EU MDR. Obtaining the UKCA
mark is proving to be a lengthy and costly exercise, when weighed against the relatively
small market that is the UK. This is prompting many companies to cease retail of their
devices in the UK. Fears are growing over not only reduced availability of devices but
what will happen when there is reduced competition between devices – it stands to
reason that this may lead to poorer quality devices being made available to the market.
Collaboration between the key stakeholders is surely the key to improving this tentative
situation. Patients, users, consumers, healthcare professionals, clinicians, health boards,
governments, regulators, notified bodies, medical device manufacturers are all involved.
In terms of patients, users, and consumers; those at the core can offer invaluable insight into
what they expect from devices and how that compares with their experiences.
Who better to offer their insight than those that are using the devices daily, healthcare
professionals and clinicians. They are experiencing the benefits and risks first hand. They can
also offer insight into conditions, alternative treatments and how patients are affected in
practice. These individuals will inevitably find themselves part of discussion within the clinical
community, addressing many areas including State of the Art, clinical incidents, and device
usability and more. Making connections and building relationships with these groups will only
serve well.
For all medical device companies, from start up to globally well established, how to make these
connections has often proven elusive. It’s a collision of two seemingly separate worlds which are
in fact completely intertwined, healthcare and industry.
All involved in the medical device industry, whether that be consumers, producers, or regulators,
all play a key role. Like cogs in a wheel, it all works together. Understanding how to connect
with the other cogs, making those connections, building, and nurturing relationships and ultimately working together for a safer, more efficient, more sustainable medical device industry
is surely the key.
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