Promote Competency-Based Training Approach in Quality,
Regulatory and Clinical Affairs to Improve MD/IVDD Safety and
Performance
Lionel Pazart
1a
, Vincent Armbruster
2
, Debora Monin
3
, Corinne Delorme
4
, Monique Borel
4
,
Damien Le Nihouannen
5
, Frédéric Barbot
6
, Fabrice Bouquet
7
, Guy Carrault
8
, Thomas Lihoreau
9
b
,
Marlène Durand
5
, Helène Clogenson
10
and Sylvia Pelayo
9,11
1
Université de Franche-Comté, UMR Inserm 1322 LINC & Inserm CIC 1431, F-25000 Besançon, France
2
Université de Franche-Comté, Institut Supérieur d’Ingénierie de Franche-Comté F-25000 Besançon, France
3
Université de Franche-Comté, SUP-FC F-25000 Besançon, France
4
Syndicat National de l’Industrie des Technologies Médicales (SNITEM) F-92400 Courbevoie, France
5
Université de Bordeaux, F-33000 Bordeaux, France
6
Université de Versailles Saint-Quentin-en-Yvelines, Univ. Paris-Sud, F-78000 Versailles, France
7
Université de Franche-Comté, Institut FEMTO-ST UMR CNRS 6174 F-25000 Besançon, France
8
Université Rennes, CHU Rennes, INSERM, LTSI - UMR 1099, CIC 1414, F-35000 Rennes, France
9
Tech4Health network – F-CRIN, France
10
Centre d’Investigation Clinique 1415, Centre Hospitalier Universitaire, F-37000 Tours, France
11
Université de Lille, CHU Lille, ULR 2694 - METRICS, INSERM CIC-IT 1403, F-59000 Lille, France
Keywords: MDR, IVDR, Training, Regulatory Affairs, Clinical Investigation, Medical Device, CE Marking,
Skills-Based Approach.
Abstract: The aim of this paper is to analyze the training needs introduced by the implementation of the European
regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR), and to analyze the
appropriateness of a competency-based training approach. Finally, a number of ideas are put forward
concerning certain topics to be addressed in a Europe-wide approach.
1 INTRODUCTION
The European regulations on medical devices MDR
(EU) 2017/745 applicable since 26/05/2021 and (EU)
IVDR 2017/746 on in vitro medical devices
applicable (IVDR) since 26/05/2022, define and
reinforce the role and tasks of the person responsible
for ensuring compliance with the regulations,
particularly within manufacturers and notified bodies.
However, this is not a new activity for medical
device manufacturers. Since the introduction of CE
marking for medical devices (MD) then in vitro
medical devices (IVDD), since 1990, these activities
have tended to be entrusted to engineers in the R&D
a
https://orcid.org/0000-0002-9104-0862
b
https://orcid.org/0000-0001-8417-6609
departments, then to those also in charge of the
company's 'quality' activities, more often as an
additional related activity to the technical day-to-day
work, depending on the size and organization of the
companies. In fact Regulatory Affairs, Quality and
Clinical Research are much linked activities in a
company and ultimately transversal.
Nevertheless, the current EU regulation
formalizes these roles with certain jobs profile to
guarantee the safety and performance of medical
devices, both within economic operators
(manufacturers, authorized representatives,
distributors and importers) and in notified bodies
(which are private companies). For the latter, the staff
842
Pazart, L., Armbruster, V., Monin, D., Delorme, C., Borel, M., Nihouannen, D., Barbot, F., Bouquet, F., Carrault, G., Lihoreau, T., Durand, M., Clogenson, H. and Pelayo, S.
Promote Competency-Based Training Approach in Quality, Regulatory and Clinical Affairs to Improve MD/IVDD Safety and Performance.
DOI: 10.5220/0012593900003657
Paper published under CC license (CC BY-NC-ND 4.0)
In Proceedings of the 17th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2024) - Volume 1, pages 842-851
ISBN: 978-989-758-688-0; ISSN: 2184-4305
Proceedings Copyright © 2024 by SCITEPRESS – Science and Technology Publications, Lda.

qualification criteria that all notified bodies must
meet are specified in Annex VII - part 3, and in
particular in paragraphs 3.2.4 and 3.2.5.
The current EU regulation strengthens its
requirements, particularly in the area of clinical
evaluation and the provision of clinical evidence, for
which manufacturers and notified bodies do not seem
to be sufficiently prepared.
It is therefore legitimate to ask what training
courses the medical device industry could turn to at
the European level in order to meet the current
requirements of the MDR/IVDR and its concrete
implications in terms of the skills to be acquired and
maintained.
2 ANALYSIS OF NEEDS,
BUSINESS PROFILES TO BE
TRAINED
Internationally, Regulatory Affairs Professionals
Society (RAPS) has initiated a number of recent
actions in the field of medical device regulation, with
many differences in approach from one country to
another.
In US, FDA (Food and Drug Administration)
provides and updates a dedicated page about
regulatory sciences
(http://www.fda.gov/ScienceResearch/SpecialTopics
/RegulatoryScience/default.htm), and has developed
in that sense several actions and programmes for
years.
France's leading trade association in the field,
SNITEM, has carried out surveys among its members
to identify the profiles needed to be recruited, and has
begun to draw up job descriptions for Regulatory
Affairs and Quality, including one for the Regulatory
Affairs Manager in the medical device industry
(SNITEM 2020). Usually reporting to General
Management or the Quality Department, this person
is responsible of regulatory compliance according to
the MDR/IVDR. Furthermore, he/she defines and
deploys the company's technical and regulatory
strategy from development, registration and operation
through to the end of the medical device's life. This
job profile needs to be strengthened and revised, in
particular through ongoing training, if we are to meet
the current clinical evaluation requirements expected
under the current European regulations. The skills
required are becoming so diverse and specialized that
there is an urgent need to think about the different
professions to be initiated, as a single person can no
longer satisfy all the requirements.
Again in France, the national working group led
in 2019 by the Ministry of Higher Education,
Research and Innovation with numerous stakeholders
(SNITEM, Pharmacy Deans Conference, French's
biomedical engineering schools., EUROPHARMAT,
Tech4Health network, INSERM F-CRIN clinical
research infrastructure, French Pharmaceutical
Students' Association, and the GMED notified body),
wanted to compare this regulatory activity, in terms
of its missions, with the responsible pharmacist in the
pharmaceutical industry. The EU MDR and IVDR
(article 15) introduce the role of the person
responsible for regulatory compliance (PRRC). Some
uncertainties remain as to the implementation of this
role. PRRCs must demonstrate that they are suitably
qualified for the role. The fact that it was not
compulsory before 2021 and the absence of official
job descriptions for medical devices have so far
limited the creation of a structured academic training
program spread evenly across the country. The
situation seems similar in many European countries.
For a company, the absence of a suitable job
profile to meet the current requirements of the
European regulation on medical devices in a CE
marking application file could de facto lead to the risk
of failure of the certification process of the
corresponding medical devices submitted to the
notified bodies. This risk is low for large companies
in the sector, but high for Small and medium-sized
enterprises (SMEs). Yet, SMEs account for more than
90% of European medical device companies. These
companies rarely have someone in their
organizational chart who is solely responsible for
regulatory affairs and has specific training as required
by the current European regulation. This finding also
indicates that, in addition to specific skills, we need
to consider a larger number of people to train.
Furthermore, when they set up their start-ups, the
entrepreneurs themselves are often unprepared for the
regulatory procedures required to get their products to
the market. This often results in serious and impactful
delays and/or failures within the first three years.
First and foremost, therefore, action needs to be
taken in the field of continuing training to bring active
professionals up to date with updated and enhanced
diplomas or certifications in QMS, regulatory and
clinical affairs, and, at the same time, to train the
professionals of tomorrow to 'arm' new companies or
those that do not yet have such qualified resources in-
house. In addition, continuous training cycles should
be envisaged, short, compatible with the daily
workload, and progressive, designed to keep
professionals up to date with the latest regulations.
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It should be noted that these training courses are
not solely aimed at manufacturers of devices, but also
and non-exclusively at those who distribute and
assess them, as well as consultants, notified bodies,
the competent authorities, etc.
For example, in France, which accounts for just
over 10% of European medical device companies, the
national working group led by the Ministry of Higher
Education, Research and Innovation mentioned
above, estimates there is a need to train 1,000 people
in regulatory affairs and quality over the next 5 years.
On this basis, a rough assessment of the need in
Europe could be envisaged with a factor of ten.
3 THE SKILLS-BASED
APPROACH TO TEACHING
The skills-based or competency-based approach to
pedagogy has evolved over the decades, reflecting
changes in educational needs, perspectives on
learning, and theoretical developments in the field of
education.
3.1 History
The first work on the competency-based approach
appears to have emerged in the 1960s, notably with
the work of the American psychologist David
McClelland (in Bouteiller 2016). He introduced the
concept of behavioral competencies, focusing on the
individual attributes and abilities needed to succeed
in specific situations. The development of
competencies was subsequently taken further, with
researchers such as Richard Boyatzis and others
developing more specific competency models,
distinguishing technical competencies from social
and emotional competencies. Competencies, in this
line of research, were defined as "underlying
characteristics of the person that led to or caused
effective or superior performance" (Boyatzis, 1982).
The competency-based approach was gradually
introduced into the field of education in the 1980s and
1990s. Education reforms in some countries, such as
France, have incorporated this approach to better
align education with the needs of the labor market.
Educational reforms around the world have often
incorporated elements of the competency-based
approach. The emphasis has been on developing
cross-disciplinary skills such as critical thinking,
creativity, communication and collaboration. The
2000s saw a proliferation of competency frameworks,
describing the competencies expected at different
levels of education. These reference frameworks have
often been developed in collaboration with the
professional world to ensure direct relevance.
3.2 The Competency-Based Approach
in University Education
The competency-based approach to university
education in engineering and health has been adopted
by a number of countries around the world, with the
aim of better preparing students for the practical
challenges of their future careers. The competency-
based approach has been gradually integrated into
engineering training in France since 2000. The
“Grandes Écoles d'ingénieurs” were pioneers in this
development. In the healthcare sector, the
introduction of competencies in medical training was
initiated with the reform of medical studies in 2009.
The aim of this approach is to train professionals
capable of meeting the real needs of the healthcare
system. Since 2022, the Objective Structured Clinical
Examination (OSCE) has been a new national
assessment method for French medical students at the
end of their second cycle of medical studies, with a
view to awarding them their internship. This
simulation-based tool provides a standardized
assessment of professional behavior and
performance, and everything that Multiple Choice
Type Questions (MCQs) cannot assess: reasoning,
behavior, communication, professionalism, etc.
OSCE was first developed in Canada and then in
Switzerland.
In Canada, universities have been gradually
adopting the competency-based approach in
engineering programs since the 2000s. The emphasis
is on developing practical skills and preparing
students for the professional environment. Health
programs, particularly in medicine and nursing, have
integrate the competency-based approach for many
years to align training with the needs of the health
system. This includes clinical placements and
practical assessments based on simulated or real-life
situations.
Australian universities have begun to adopt the
competency-based approach in engineering programs
over the last few decades. The aim is to produce
engineers who are adapted to the requirements of
industry. Health programs in Australia, such as
medical education, incorporate the competency-
based approach to prepare students for various
aspects of medical practice, including
communication, inter-professional collaboration and
clinical skills.
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In the Netherlands, the competency-based
approach has been increasingly integrated into
engineering programs since the 2000s, with an
emphasis on practical and professional skills. Health
training programs in the Netherlands have adopted
the competency-based approach to train multi-skilled
health professionals capable of adapting to rapid
changes in medical practice, particularly in the
context of digital health.
The arguments in favor of the skills-based
approach in these countries include the need to better
align training with the real current and future needs of
the labor market, to encourage the development of
practical and professional skills, and to prepare
students to be operational as soon as they enter the
professional world. This approach also aims at
fostering students' autonomy, creativity and ability to
adapt to various situations they will encounter in their
future careers, and so particularly suitable to the
complexity of medical device field and the projects
that could be said to be almost each tailor-made.
3.3 Recent Developments
With the advent of information technology, the skills-
based approach has broadened to include digital
skills. Modern societies now require individuals to
master technology-related tools and skills. The rapid
evolution of society has led to the recognition of 21st
century skills, encompassing critical thinking,
problem solving, creativity, collaboration,
communication, digital citizenship, and lifelong
learning.
Although the competency-based approach has
developed significantly, it also faces challenges and
criticism. Some question the standardization of skills,
stressing the importance of contextual and cultural
skills. In addition, assessing skills remains a complex
challenge.
4 COMPETENCY-BASED
APPROACH TO MDR/IVDR
TRAINING
A competency-based approach to training in
European regulations on medical devices would be of
major interest in the current context of companies that
are often small in size, and having a business based
on small specialized product ranges. This approach,
which focuses on developing the practical skills of
professionals, offers a number of significant
advantages.
4.1 A Specific Area
It is important to stress that European regulations on
medical devices are a complex and constantly
evolving field. Professionals working in this sector
must not only understand the regulatory texts, but also
be able to apply them concretely in their daily
practice, anticipating the constraints imposed. For
example, it would be totally counterproductive to
choose materials for the components of a medical
device in contact with biological tissues solely on the
basis of their physico-chemical or mechanical
properties, if these materials turned out not to be
biocompatible. The skills-based approach makes it
possible to meet this requirement by emphasizing the
acquisition of specific know-how and the ability to
solve concrete problems related to regulations.
4.2 Specific Skills
By adopting this approach, training courses can focus
on developing key skills such as interpreting
standards, quality and risk management, regulatory
monitoring and implementing good clinical practices
(GCPs). In this way, graduates would be better
prepared to meet the practical challenges they will
face in their professional environment. The aim is to
go beyond the simple acquisition of theoretical
knowledge to foster a genuine range of the skills
needed to assume responsibility for regulatory
compliance.
In addition, the skills-based approach encourages
the development of critical thinking and adaptability.
In the field of medical devices, regulations can evolve
in response to technological advances, safety issues,
feedback from experience and use, or updates in
clinical practices or “gold standards” Professionals
trained in this approach will be better prepared to
assimilate new information, adjust their practices and
innovate in compliance with current regulatory
standards.
This approach also encourages cross-disciplinary
skills. Professionals in the medical devices sector
often have to work with experts from different
disciplines (engineers, clinicians, quality managers,
etc.) both inside and outside the company.
Competency-based training helps to develop a global
and interdisciplinary understanding of regulations,
strengthening the ability of teams to work coherently
and collaboratively.
Finally, the skills-based approach means that the
realities of the field are better taken into account.
Professionals are faced with a wide variety of
situations, some of which are unforeseen.
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Competency-based training prepares them to manage
these situations by mobilizing the knowledge they
have acquired through their experience and training
in a relevant and effective way. This helps to ensure
that regulations are applied more effectively and that
the quality and safety of medical devices on the
European market are optimized.
4.3 Integrating Clinical Evaluation into
MDR/IVDR Training Courses
The integration of clinical evaluation into training
courses devoted to European regulations on medical
devices has become a strategic obligation in order to
train competent and well-prepared professionals in
this specific field. Clinical evaluation brings a
practical and concrete dimension to the understanding
of regulatory requirements, offering several
significant advantages.
It is essential to emphasize that European
regulations on medical devices attach particular
importance to clinical evaluation, which is considered
to be a central element in demonstrating the safety
and performance of medical devices. The inclusion of
this dimension in training enables professionals to
fully understand the challenges and usefulness of
their work, and underlines the importance and scope
of clinical evaluation in the process of bringing
medical devices to market.
Clinical evaluation in training courses offers a
unique opportunity to apply the theoretical
knowledge acquired through documentary research
or e-learning to practical situations. Learners are
confronted with real-life cases that simulate the
challenges they will face in their professional
practice. This not only reinforces their understanding
of regulatory concepts, but also enables them to
develop specific skills related to planning, conducting
and analyzing relevant and demonstrative clinical
evaluations, in relation with the specialists in the
medical and clinical research field. It is also to notice
that MDR underline the importance for
manufacturers (but also notified bodies) to be
surrounded and use support by clinicians’ experts
when necessary.
By integrating clinical evaluation into their
training, professionals acquire an in-depth
understanding of the methodologies and good
practices associated with this process. This includes
designing evaluation protocols, thinking about how to
collect and analyze clinical data, managing clinical
risks, and communicating results to patients,
healthcare professionals and the relevant authorities.
These practical skills are essential to guarantee
compliance with regulatory requirements and ensure
patient safety.
Clinical evaluation also encourages professionals
to develop a critical and ethical approach. They are
required to critically appraise clinical evidence (in
particular to establish the state of the art, the first
pillar of any clinical evaluation), to anticipate and
resolve potential ethical problems, and to ensure
informed decision-making based on the results of the
evaluation. These skills are crucial in a regulatory
environment where patient protection and the quality
of clinical data are absolute imperatives.
The inclusion of clinical evaluation in training
courses also strengthens interdisciplinary
collaboration. Professionals working in the field of
medical devices often have to collaborate with
clinicians, researchers, statisticians and other experts.
Training that includes clinical evaluation encourages
teamwork, effective communication between the
various stakeholders and an understanding of the
issues specific to each discipline.
4.4 Ways of Developing a Skills-Based
Approach to the MDR/IVDR
The skills to be acquired should initially be defined in
terms of knowledge, know-how and interpersonal
skills for each of the job profiles envisaged at the
end of the course (e.g. Regulatory & Clinical Affairs
Manager, Clinical Affairs Project Manager,
Regulatory Affairs Project Manager, Notified Bodies
–NB Auditor, NB Internal Clinician, NB Clinician
specialist, Competent Authority Project Manager,
Hospital MD quality management system
manager…).
It should be possible to define a level of expertise
according to the profile envisaged, to be reached
at the end of the training:
 Basic: basic skills = the person has been
given the concepts, knows how to find the
resources to do what they need to do, given
time and a guide (written document, tutorial
or coach).
 Acquired: competence acquired = the person
knows how to manage standard cases
autonomously. If there are no particular
difficulties, they can manage on their own
but need help with difficult cases.
 Expert: fully mastered skill = the person
knows how to do standard cases very well,
but also difficult or complicated cases
independently. This person could manage
and train other people to improve control of
the activity.
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By way of illustration, here are a few new skills
in the field of clinical evaluation that could be
envisaged for a person responsible for Regulatory &
Clinical Affairs:
 master the relevant requirements of the
regulation, common specifications,
guidance documents and harmonized
standards,
 be able to carry out a clinical evaluation with
its various components and in collaboration
with an expert team (state of the art, clinical
investigation, opinion of clinical experts,
equivalence analysis)
 be able to issue a reasoned judgement on the
opinion given by any external clinical expert
and extract a scientific and ethical summary
from these expert opinions,
 be able to write synthetize this information
and based on that provide decisions, by
reports demonstrating that the clinical
evaluation activities (for CE marking or its
renewal) have been carried out adequately.
 Be able to analyse the risks associated with
the use of medical devices
 Be able to take part in strategic regulatory
analysis for the development of a new type
of medical devices
 Be able to use adequately new tools based on
Artificial Intelligence as ChatGPT or Elicit.
More generally, on completion of the course,
graduates intended for companies should be able to
contribute actively, with a high level of autonomy, to
the activity of the company's regulatory affairs
department (management of CE marking
applications). The training should enable them to
support the regulatory activities of clinical trials,
vigilance and post-market clinical follow up.
Graduates will have a detailed knowledge of the
requirements and organization of the healthcare
industry, and should be able to work within it, with
the necessary interaction between departments. They
will also be able to understand, analyze and respond
to requests from notified bodies and health
authorities. Graduates will thus be destined to occupy
a position of senior management responsibility
immediately.
Students heading for the manufacturing industry
will need among other things to be able to:
 interpret a medical need or regulatory issue
arising from the professional environment,
 develop and implement a working
methodology for the design of new medical
devices, in compliance with standards and
regulations (including GDPR)
 Identify the issues at each stage of the
medical device's life cycle, from the idea to
post-market surveillance,
 evaluate and optimize the performance of
new medical devices, particularly during
their development, with an ecological
perspective of sustainable development,
 contribute to and collaborate on an
interdisciplinary project in the field of health
technologies,
 understand the
needs/expectations/constraints of all the
players involved in order to facilitate market
access for an innovation,
 communicate scientific results clearly,
ethically and rigorously,
 etc.
The training program should include the learning
of "soft-skills" such as:
 Project management: tools and methods
 Literature monitoring (scientific and
regulatory
 Communication skills: practicing oral and
written presentations (poster, flyer,
promotional literature, etc.)
 Skills in managing project meetings
 Crisis management (simulation model)
 Use of tools based on Artificial Intelligence
A number of teaching methods (e-learning,
streaming, videoconferencing, webinars, reverse
learning with interactive videoconferencing of
questions, Masterclasses, mini-projects, cycles of
meetings with entrepreneurs, observation periods in
companies, work experience with experienced
professionals in the same way as the ECOS
mentioned above, etc.) should be available in addition
to traditional work placements or alternating with
work in a professional environment.
Each student should have a personalized course
portfolio. Each planning is intended to be shared by
the resource people involved in the learner's training
pathway.
It should be used to monitor the student's progress
through the program and to capitalize on the skills
acquired during the course and work placement in
order to obtain the University Diploma.
The main objectives of this tool are:
 encourage self-assessment of the gap
between the knowledge acquired (courses
received) and the know-how required
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(practical application during projects and
placements);
 enable the referents and trainers involved to
understand where the learner is in his or her
vocational training pathway and to better
measure the remaining needs;
 position what has been learnt in relation to
what is required at the end of the diploma;
 Encourage self-motivation, as each student
is involved. Indeed the choice of courses
will depend on his/her own objectives, so
he/she may feel even more involved with the
training.
The acquisition of skills during training should be
attested by a formative assessment mechanism
throughout the course and finally by a summative
assessment leading to certification or a university
diploma.
5 TOWARDS A EUROPEAN
APPROACH TO MDR/IVDR
TRAINING
European regulation of MD/IVDD is a complex and
crucial area that governs the marketing of these
products in the European Union. Although the
regulations themselves are harmonized at the
European level, there may be variations in the
approaches taken by different member states
regarding training on these regulations. This
comparison could highlight differences in teaching
methods, priorities and resources invested in training
professionals in the medical devices sector.
5.1 Differences to Be Aware of
It is important to note that variations between the
approaches of different European countries may
originate in cultural & political differences, national
health priorities or distinct educational systems. Some
countries may place greater emphasis on specific
skills related to the regulation of MDs and IVDDs due
to particular needs within their healthcare system.
Although the European regulations on MD and
IVDD are the same for all European countries in
terms of the equivalent of marketing authorization,
there are other regulatory points to be taken into
account by manufacturers wishing to establish
themselves on the European market.
After CE marking, clinical studies on medical
devices are usually carried out for two purposes:
 to convince physicians of the device's
interest and clinical usefulness
 to enable decision-makers to determine the
eligibility of these new devices for
reimbursement.
Both objectives require in-depth knowledge of
country-specific regulations, which are not covered
by the RDM or IVDR:
 regulatory procedures for initiating clinical
trials
 regulatory procedures for obtaining
reimbursement.
In this section, we will focus solely on the
procedures for obtaining reimbursement, identifying
the organizations in the main European countries and
the criteria for reimbursement eligibility.
The reimbursement mechanisms for medical
devices vary from one European country to another,
depending on their respective health systems and
political choices. This point is not covered by RDM
and RDIV. Reimbursement procedures are not
managed at EU level, and each country's procedure
should therefore be known by any company wishing
its product to be distributed throughout Europe. CE
marking certainly gives a license to place the product
on the market, but, in most cases, the hardest part is
still getting the market to adopt and buy the product.
The reimbursement stage is therefore crucial, and is
specific to each country. This information is vital not
only for manufacturers, but also for all those involved
in the development and evaluation of medical devices
in Europe.
Here are a few examples from the main European
countries.
In France, medical devices are reimbursed by the
national health insurance “Assurance Maladie.” The
French National Authority for Health (HAS) assesses
the relevance of medical devices before they are
reimbursed. Devices are classified into categories
(LPPR - Liste des Produits et Prestations
Remboursables) according to their medical
usefulness. This reimbursement system has been in
place for several decades, but HAS assessments have
been strengthened over time. France aims to ensure
that patients have access to high-quality medical
devices while controlling costs. Relevance
assessments by the HAS aim to ensure the
effectiveness and safety of the devices reimbursed.
In Germany, medical devices can be reimbursed
by health insurance funds. The decision to reimburse
depends on an assessment by the Federal Institute for
Quality and Efficiency in Health Care (IQWiG), a
process that was strengthened in the early 2000s.
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Germany seeks to guarantee the efficiency of
healthcare spending by rigorously evaluating the
effectiveness of medical devices before they are
reimbursed.
In the UK, medical devices are assessed by the
National Institute for Health and Care Excellence
(NICE). Since Brexit, UK no longer applies RDM
and IVDR, but a specific attention is given to product
already CE marked. Reimbursement is determined by
Clinical Commissioning Groups (CCGs) within the
National Health Service (NHS). NICE was set up in
1999, but the appraisal process has been strengthened
over the years. The UK seeks to optimize the use of
resources by assessing the clinical value of medical
devices to ensure the best quality of care.
In the Netherlands, medical devices are assessed
by the Dutch College of Health Technology
Assessment (ZIN). Reimbursement is managed by
compulsory health insurance. The current system has
been in place since 2000. Patients have to pay from
their own pockets in some cases. “The "own risk"
amount (“eigen risico”), which is an annual amount
that you must pay out of your own pocket for some
treatments and medicines before your health
insurance will cover the rest ». The Netherlands seeks
to ensure the quality and effectiveness of healthcare
by assessing medical devices before reimbursing
them.
These approaches aim to reconcile patient access
to innovative medical devices, cost containment for
healthcare systems and quality assurance of care.
Prior assessment aims to ensure that reimbursed
medical devices are both clinically effective and
economically viable.
In Belgium, medical devices are reimbursed by
the INAMI (Institut national d'assurance maladie-
invalidité). Reimbursement is based on a specific
nomenclature, the List of Products and Services
(LPP), which sets out the conditions for
reimbursement for each medical device. The
reimbursement system for medical devices has been
in place for several decades, and adjustments have
been made over time. Belgium's aim is to guarantee
patient access to essential medical devices while
maintaining rigorous management of healthcare
expenditure. The nomenclature aims to standardize
and control reimbursements to ensure that resources
are used appropriately.
In Poland, reimbursement of medical devices is
managed by the National Health Fund (NFZ -
Narodowy Fundusz Zdrowia). Medical devices must
be included on the list of reimbursable products to be
eligible for reimbursement. The reimbursement
system for medical devices in Poland has evolved
over the years, becoming more formally structured
over the last two decades. Poland seeks to ensure fair
access to medical devices by reimbursing those that
meet the health needs of the population. Inclusion on
the list of reimbursable products is based on criteria
of effectiveness, safety and impact on public health.
In these last countries, reimbursement
mechanisms aim to ensure equity of access to
necessary medical devices while maintaining
efficient management of healthcare system resources.
The establishment of specific lists and the definition
of eligibility criteria are approaches adopted to
guarantee the clinical and economic relevance of
reimbursed medical devices.
In Spain, reimbursement for medical devices is
part of the Sistema Nacional de Salud (National
Health System). Medical devices are included in the
health system's common catalogue of services, and
reimbursement is determined on the basis of criteria
of effectiveness, safety and clinical usefulness.
Access to medical devices is based on a doctor's
prescription. The reimbursement system has been in
place for several decades, with regular adjustments
over time. Spain also aims to guarantee equitable
access to necessary medical devices, ensuring that
their use is based on sound clinical evidence. The
system also aims to maintain the economic viability
of the healthcare system.
In Portugal, reimbursement of medical devices is
managed by the Serviço Nacional de Saúde (National
Health Service). Medical devices are included in the
Index Nacional de Dispositivos Médicos (INDM -
National Index of Medical Devices), which
determines the conditions for reimbursement. Access
to devices is also linked to medical prescription.
Portugal aims to guarantee the quality of healthcare
by reimbursing medical devices that meet high
standards of effectiveness and safety. Using the
INDM facilitates the management of reimbursements
and ensures transparency in the process.
In Italy, reimbursement of medical devices is
managed by the Servizio Sanitario Nazionale
(National Health Service). Medical devices are
included in the Tariffario Nazionale delle Prestazioni
(National Tariff of Benefits), which defines costs and
reimbursement conditions. Access to devices is
conditional on a doctor's prescription. Italy aims to
guarantee effective healthcare by reimbursing
medical devices that meet quality standards. The
Tariffario Nazionale delle Prestazioni facilitates cost
management while ensuring the availability of
necessary devices for patients.
In these last three countries, coverage for
medical devices is based on national healthcare
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systems. Access to devices is generally linked to a
medical prescription, and reimbursement
arrangements are defined by national catalogues or
tariffs. The arguments put forward are to guarantee
access to the necessary medical devices while
ensuring their clinical effectiveness and the economic
viability of the healthcare system.
5.2 Differences in Teaching Methods to
Be Explored
In terms of teaching methods, some countries may
favor a more practical approach, focusing on concrete
case studies and simulations, while others may opt for
a more theoretical and academic approach. These
differences may be influenced by national
educational traditions and the resources available for
training.
The levels of detail and requirement in training
programs may also vary. Some countries may impose
stricter standards and require more in-depth training,
while others may adopt a more flexible approach,
leaving healthcare professionals more room for
maneuver in understanding and applying the
regulations.
Furthermore, EU member countries may have
different priorities when it comes to regulating
medical devices, depending on their own public
health challenges, the size of their medical device
industry and their specific economic circumstances.
For example, a country with a strong medical device
industry may place greater emphasis on the training
of industry professionals, while a country with an
ageing population may pay particular attention to the
training of healthcare professionals involved in the
clinical use of medical devices.
The financial and human resources devoted to
training can also vary considerably from one country
to another. Some countries may invest more in the
development of sophisticated training programs,
while others may be resource-constrained and favor
more cost-effective approaches.
Despite these differences, it is important to
emphasize that the common objective of all training
approaches in the EU is to ensure that professionals
comply with common regulatory standards and that
medical devices are safe for patients. Collaboration
between regulators, training organizations and
healthcare professionals can help to further
harmonize these approaches and share best practice,
and at the same time to personalize the way an expert
that will be trained can provide the most adapted
intervention and impact positively a medical device
project.
6 CONCLUSION
In conclusion, a training strategy adapted to
regulatory constraints can be a formidable tool in the
service of EU competitiveness.
The competency-based approach to training in
European regulations on medical devices represents a
relevant teaching strategy that is adapted to the
current challenges facing the healthcare industries.
By focusing on the development of practical skills,
this approach provides professionals with the tools
they need to successfully navigate a complex and
constantly changing regulatory environment.
More specifically, integrating clinical evaluation
into training courses devoted to European regulations
on medical devices offers substantial advantages. It
enables professionals to acquire essential practical
skills, to fully understand the importance of the issues
at stake and of clinical usefulness, and to develop a
critical and ethical approach. These skills are
essential for ensuring regulatory compliance, patient
safety and the quality of medical devices on the
European market.
A comparison between the approaches of different
European countries to training in European medical
device regulation could reveal significant diversity in
terms of teaching methods, national priorities and
resources allocated. However, it would be essential to
maintain a degree of fundamental harmonization to
ensure the effectiveness and uniformity of the skills
acquired by medical device professionals across
Europe, in response to the expectations of the
MDR/IVDR but above all of patients and healthcare
professionals.
FUNDINGS
This publication corresponds to the conceptual
framework of a project financed by the France 2030
programme "Skills and Professions of the Future"
with the support of the Agence Nationale de la
Recherche (ARCLIMED project ANR-23-CMAS-
0002).
ACKNOWLEDGEMENTS
This article would not have been written without the
contribution of the work carried out by all members
of the ARCLIMED Consortium. This article will
reflect their proposals . The authors would like to
thank them. The authors also express their gratitude
ClinMed 2024 - Special Session on European Regulations for Medical Devices: What Are the Lessons Learned after 1 Year of
Implementation?
850

to the administrative staff of the various partners
taking part in the ARCLIMED project. Special thanks
to Norbert Noury for proofreading the English
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