Practices and Requirements of Stakeholders Involved in the Clinical

Evaluation of Innovative High-risk Medical Devices: A Qualitative

Study

Catherine Roussel

, Alexandrine Salis

and Sylvia Pelayo

INSERM CIC 1415, University Hospital, Tours, France

INSERM FCRIN UMS 015, University Hospital, Toulouse, France

Univ. Lille, INSERM, CHU Lille, CIC-IT 1403 - Centre d'Investigation Clinique, EA 2694, F-59000 Lille, France

Keywords: High-risk Medical Device, Risk, Evaluation, CE Marking.

Abstract Medical Devices are health products that combine complex technologies and new organizations. They are

under high constraints, both economic and regulatory, but also in terms of quality and safety requirements.

The new European regulation comes in addition and questions all of the actors of the maturation process from

the idea-to-market for medical devices (MDs). The objective of this qualitative study was to collect and

analyze feedback from various European stakeholders involved in the clinical evaluation of medical devices,

with a special focus on innovative high-risk medical devices. This paper presents the results of the first phase

which scope was limited to France with sixteen interviews. Results show the complexity of the clinical

evaluation of MD, particularly when dealing with an innovative, high-risk medical device. The need for

training and support of actors through specialized platforms was highlighted, as well as the need for

coordination between public and private actors, from the upstream phases of R&D. The collection of clinical

data must be part of an overall strategy considering the maturation cycle of the product and its different

dimensions. The collection of real-life data must be amplified and structured, with the contribution of new

digital technologies opening up new fields of research. This approach must be strengthened by (i) the

development of methods based on choices justification, and (ii) making it possible to capitalize on and cross-

reference data on the Medical Device throughout its life span. The brief overview provides convergent

conclusions, but the understanding of the required level for the evaluation of medical devices and of the way

to reach it was not uniform. This reflects a heterogeneous sector and it introduces the need of compromises

regarding development strategies and methodological approaches.

1 INTRODUCTION

What complexity when you are interested in medical

devices (MDs) and their evaluation! You find a large

and heterogeneous field of products with a

combination of advanced technologies. These are

essential tools in the delivery of innovative medical

care, in acute or chronic diseases as well as care of the

elderly. The transformational process from the idea to

the market requires many actors and experts to go

beyond high constraints as performance and safety of

the medical device, quality, regulatory, and economic

requirements. Scientists, industrialists and regulatory

bodies are lead to improve their skills and

organizations to be able to develop robust evaluation

of their MDs. Thus, they will ensure a better access

of European innovations in competitive international

markets. Approaches and methods for MDs

development are very specific, particularly with

regard to clinical evaluation. Stakeholders of the

domain are concerned about the impact of the new

European regulation (UE) 2017/745 which now

requires to carry out clinical investigations for high-

risk devices (current class III medical devices and

implantables), this based on a stringent and

continuous evaluation plan all along the product

lifetime. Regarding the dynamic of the industrial

sector mostly containing very small or small

companies, these changes have to be supported. In

this context, it is interesting to question the level of

convergence of the various stakeholders involved in

the evaluation of MDs, in terms of practices and

needs, especially for the development of innovative

high-risk devices.

Roussel, C., Salis, A. and Pelayo, S.

Practices and Requirements of Stakeholders Involved in the Clinical Evaluation of Innovative High-risk Medical Devices: A Qualitative Study.

DOI: 10.5220/0009372903290336

In Proceedings of the 13th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2020) - Volume 1: BIODEVICES, pages 329-336

ISBN: 978-989-758-398-8; ISSN: 2184-4305

329

The purpose of the project was to gather and

analyse feedback from European stakeholders

involved in the clinical evaluation of innovative,

high-risk medical devices: academic researchers,

clinicians, promoters, notified bodies, French health

authorities, the ANSM (French Agency for the Safety

of Health Products), the HAS (the French national

Health Authority), the CNEDIMTS (the National

Commission for the Evaluation of Medical Devices

and Health Technologies) and manufacturers. This

work was a first step focused on French stakeholders.

The objectives were:

 to elucidate how the clinical evaluation of medical

devices is performed;

 to grasp the key points and success factors in the

clinical evaluation of medical devices;

 to evaluate the main obstacles to the development

of medical devices;

 to identify the various expectations and

recommendations of all those involved.

2 METHOD

An exploratory research method was used to

investigate the question, not clearly defined and

formalized at the time being, to have a better

understanding and overview. The method of survey

was chosen to gather information from a predefined

group of respondents. A group representing most of

the relevant stakeholders in the domain was defined

to reach as far as possible data saturation. Semi-

structured interviews were performed with the

various players in the MD sector over a period of one

and a half months, from the end of March to mid-May

2019.

Stakeholders who took part in the study were all

involved in the clinical evaluation of innovative

medical devices. The sample was chosen to be

representative of all those involved in the cycle of

innovation, both from the public and private sectors :

academic promotors (head of platform,

methodologist and project coordinator in a living lab),

university hospital pharmacovigilance manager and

the head of the medical device committee

(Commission for medicinal products and sterile

Medical devices- COMEDIMs), University Hospital

surgeons (orthopaedic surgery network) and private

clinic surgeons, representatives from the medical

device industry (CEO, regulatory officer, distributor),

SNITEM professional organisation, French

authorities in charge of evaluating the ANSM files,

HAS files.

All stakeholders were asked to talk about their

practices, needs, difficulties and potential suggestions

to facilitate the process. The contents of the

interviews were processed in a transversal way to

pinpoint recurring themes and keywords from the

verbatim reports, with two readings performed by 2

independent operators.

Sixteen interviews were performed lasting ~1

hour. Eleven interviews were held over phone and

five of them were face-to-face. All the verbatims were

transcribed. A content analysis was performed to

identify the most recurrent themes. The most

significant verbatims were kept to illustrate the

purpose and to respect the integrity of the statements

without any bias.

3 RESULTS

Feedback from the experiences of the participants

particularly emphasized the heterogeneity of the

sector and the diversity of existing MDs. Nine topics

of interest presented hereafter, transpired from the

study: first, the particular aspects to MDs were

naturally highlighted. The eight other topics merge in

two parts: on the one hand the key points related to

the evaluation of MDs, including the risk assessment,

and on the other hand the needed strategy for

developing MDs. These results are close to already

known data, in particular some of which were

presented in the General Economic Council reports

(Picard, 2017, 2019).

3.1 Particular Aspects of MDs

What came out of this work is that the demonstration

of conformance to essential requirements requires to

take into consideration many specific aspects to MDs

and their evaluation. Indeed, while some aspects are

common to the development of a drug or a health

product in general (regulatory aspect, extension of the

indication, collaborative mode, risk, market…), some

others are typical of the evaluation of MDs (e.g.

evolutivity, usability, engineering, performance,

psycho-social aspect, context of use).

High-risk MDs are all the more concerned by

issues such as instrumental, biocompatibility,

reprocessing procedures, product lifespan and real-

life monitoring aspects.

With this in mind, one of the new requirement

imposed by the new European regulation could help:

the unique reference number of legacy devices (IUD)

which will be used for the registration on a european

database named EUDAMED. This new interoperable

ClinMed 2020 - Special Session on Designing Future Health Innovations as Needed

330

EUDAMED will be multipurpose: a registration

system, a collaborative system, a notification system,

a dissemination system (open to the public). Thus,

IUDs could help monitor the device timelife and

influence both the evaluation approach and the

overall strategy plan.

One of the Success Factors in the Development

of a MD is the Consideration of All These

Specificities and in All the Various Aspects of the

Evaluation, Right from the Early Stages and

Throughout the Product Lifetime.

3.2 Evaluation Approach for MDs

3.2.1 Issues with the Instruction of Study

Design Files by the Different

Competent Authorities

The European regulation (UE) 2017/745 introduced a

reinforcement of responsibilities and scope of

regulatory authorities. In France, this has

significantly modified the studies concerned, the

involved actors and the CE marking files evaluation

process, which has led to difficulties with regards to

the files instruction:

 Within the Institutional Review Board (IRB):

blockages, longer waiting times, disparity of

evaluations, lack of expertise of members of the

boards, increase in the volume of studies.

 Reinforcing the Skills of Notified Bodies (NB)

is Also Identified as a Necessity: the European

regulation has a strong impact on the NBs work:

difficulties in obtaining or renewing CE marking,

blockages, lack and search for competence; the

NB’s expectations are reinforced with

anticipation (right from before 2020); evaluations

depending on evaluators; the lack of clarity in

regulatory requirements giving way to

interpretations, and leading to differing opinions

within the teams of evaluators; heterogeneity of

expectations for the validation of special

processes (sterilisation, cleaning) between Class

IIa and III MDs.

 Better Linkage between Expectations and the

Responses of the Various Regulatory

Authorities Has Become Essential: A lack of

clarity in recommendations transpired as well as a

lack of coherence or linearity in the evaluations

« a superposition of evaluations » and the absence

of a direct link between evaluations, causing

misunderstandings. CE marking evaluation and

evaluations for reimbursement purposes

correspond to different requirements. The

manufacturers need to really know the

requirements of each desk as well as their criteria,

in order to coordinate their studies and capitalize

the data collected. This requires good

coordination in the recommendations in a context

of regulatory change.

A strong Expectation for Official Guidelines

(Regarding European Regulation) Was Brought

to Light, as Well as the Necessary Corresponding

Training for All Those Involved to Avoid

Evaluator-Dependent Evaluations.

On the other side, authorities have reminded the

importance to improve the quality of submitted files

with a robust, rigorous and scientific procedure.

One of the Recommendations Was to Carefully

Line up the File-building for the CE Marking with

the Expectations of the Regulatory Bodies; a

Strong Argumentation for the Technical and

Methodological Choices May Help the Evaluators

When Examining the Files.

3.2.2 Importance of a Multidisciplinary

Evaluation Approach

Several points were emphasized by the different

stakeholders:

 The importance of integrating a global highly

expert multidisciplinary approach in the

evaluation of a medical device was especially

emphasized by health authorities;

 All of the participants agreed with the need to

facilitate connections and interfaces, with

accompaniment from platforms or structures,

“specific and reactive places for evaluation”, to

stimulate the clinical investigations and reinforce

the cooperation between industrials and academic

centers (e.g. https://www.cic-it.fr/ ;

https://www.forumllsa.org/).

Formalising the industrial’s expectations right

from the first contacts by using specific tools as a

« Project form» is advised by the platforms

managers;

 The difficulty of billing this accompaniment (e.g.

in the file-building stages of application to Calls

for Projects),

 A reminder that the members of regulatory

authorities don’t have an advisory role;

 The lack of visibility on existing academic

support structures and the lack of gateways.

The Importance of Developing a

Multidisciplinary Approach to Get through All

the Stages of the MDs Life Cycle Was Elucidated

Along with the Contribution by Dedicated

Platforms/Structures and Academic Skills.

Practices and Requirements of Stakeholders Involved in the Clinical Evaluation of Innovative High-risk Medical Devices: A Qualitative

Study

331

3.2.3 Recommendations from Competent

Health Authorities for Clinical

Investigation

Stakeholders from the different health authorities’

structures stressed several specific points related to

clinical investigation:

 To search for a cutting-edge infrastructure where

studies can be conducted, to be able to comply

with both logistics and reactivity needs;

 The idea of « right choice » is highlighted for

several aspects, i.e. not just regarding the “right”

investigators, but also the “right” location of

investigations and the “right” methods;

 To justify the procedure, the made choices with a

logical approach: « What question do I have to

answer? What would be the appropriate

methodology? Why can’t the ideal model be

applied? How can I break down the model and

how can I justify the final methodology I’ve

chosen? »

 The advisable sources can be found on the HAS

website (HAS, 2017, 2019). The methodological

guides of the United Kingdom (NICE Guidelines

– National Institute for health and Care

Excellence) are also quoted as a reference.

The Justification of Choice in Terms of

Methodological Approach is Strongly

Recommended by People in Charge of Evaluating

Regulatory Files. The Choice of the Best

Methodology Depending on the Specificities of a

MD is Presented as a Key Factor. Thus,

Establishing Original Models is One of the Major

Challenges for the Domain. With This in Mind,

Public/Private Collaborations Appeared to be

Essential. The Importance of Being able to

Identify the Right Investigators was Emphasized,

as Well as Being Able to Find the Supporting

Structures. Those Are Essential for the Smooth

Running of Studies.

3.2.4 Importance of Users and Usability

Studies

The points underlined about usability studies were as

follows:

 The importance of taking into account feedback

from users in the development of a MD;

 Usability studies which may take place early in

the process and all along the development cycle;

 Usability formative evaluations positioned

upstream may lead to early feedback;

 In final phases, the absence of new risks may be

validated through usability summative evaluation

before CE marking: the figures are well defined,

with a clear purpose, the method is clearly

identified, i.e. user testing. The medical device’s

risk level does not seem to have any impact;

 In the design phase, the degree of fidelity of the

simulation may be greater or lesser depending on

the type of MD, with a high level simulation for

high risk medical devices (simulation

laboratories, phantom);

 During post-market evaluation, interviews may

serve to understand the actual use and feedback on

incidents; a decision tree may be formalized to

evaluate the interest of going back to a usability

evaluation. The risks related to the use of the MD

must be re-assessed as the MD evolves. For these

real-life studies, the methods are the same but

study designs must be provided for depending on

the context: town/hospital, public/private sector,

etc.

 The interest of developing protocols combining a

clinical study with the use of the MD is stressed.

However, these methods have not yet been

completely successful: « It’s complicated to add

an extra secondary objective to a protocol which

already holds many questions. The investigation

time may still be leveraged to lead to ancillary

observations ».

Usage Studies (User-based Studies) Now Have

All Their Importance in the Evaluation of

Technological Innovations and May Be Used and

Adapted throughout the Lifecycle of MDs. In a

Context Dictated by Organizational, Time and

Budgetary Restrictions, it Has Become Interesting

to Develop Methodological Approaches

Combining Both Clinical and Usage Aspects.

3.2.5 Role of the MDs Risk Level

Finally, one of the purposes of this work was to

identify the role of the risk level of the MD in the

strategy and the evaluation methods:

 The notion of risk appeared as a rather relative

datum: « Rather talk about MDs subjected to

mandatory clinical investigation; not forgetting

everything that’s non-implantable (quality

defects, raw materials); there is no “small” DM

».

 The evaluation methods were not presented

differently by the participants according to the

MD Class. The essential requirements are similar

whatever the Class, just the level of requirements

is higher with a mandatory clinical investigation

for implantable and Class III MDs (except in cases

ClinMed 2020 - Special Session on Designing Future Health Innovations as Needed

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wherein resorting to existing clinical data may be

rightly justified).

 The HAS report on the elaboration of guidelines

on the methodological specificities of clinical

evaluation for MDs indicates that « the methods

for evaluating connected medical devices are

identical to those of other devices… the

complexity of evaluating a connected medical

device has been emphasized due to its

organisational impact and its impact on the

patients ». The CNEDiMTS files evaluated in this

report concern many implantable connected

medical devices.

 The ANSM’s « Degree of originality » form

relative to medical devices proposes several

degrees of originality (from minor to major

innovation), depending on the level of

technological breakthrough and clinical impact.

Perhaps this type of segmentation could act as a

better guide for new methodological

recommendations than categories of risk?

It Was Revealed That a MD Should Be

Analysed as a Whole, beyond Merely Identifying

the Risk Category. « The clinical investigation is

mandatory for implantable and Class III medical

devices, and its absence remains the exception ».

3.3 Overall Strategy for MDs

Development

3.3.1 Critical Points for the Small

Companies and Start-ups of the MDs

Domain

Several points were highlighted as critical for small

companies or start-up:

 The importance of having a strategic vision right

from the design stage and defining the position of

the MD in the therapeutic arsenal early on.

 The importance of involving experts in the field

(health professionals, key opinion leaders) right

from the early stages to match the requirements of

industrials with the expectations of clinicians and

establish the development plan. The

manufacturer’s participants emphasized the

difficulties in identifying and approaching clinical

experts. Most of the participants agreed on the fact

that public platforms/structures could facilitate

this contact.

 The importance of working out the business plan

very early on (target: French, European or other

market) in order to anticipate the procedures and

studies to be carried out; plan the economic model

from the outset depending on the claims, potential

sources of funding, and envisage public/private

collaborations to benefit from national or

European public funding. The HAS (French

national Health Authority) innovation grant

provides co-funding for clinical studies on highly

innovative medical devices by the public

authorities. “The sense of anticipation is a key-

factor for DMs development”.

 Work is currently being carried out to establish

centralised procedures on a European level:

EUnetHTA network (European Network for

Health Technology Assessment), and INAHTA

(International Network of Agencies for Health

Technology Assessment), and early meetings are

being set up.

To Manufacturers, We Give the Following

Advices: Anticipate Their Overall Strategy,

Validate Their Clinical Claims with Experts from

the Field and Anticipate Their Economic Model.

3.3.2 Access to the Market and

Marketing

It is recommended that manufacturers anticipate the

reimbursement request process: in France, the

National Commission for the Evaluation of Medical

Devices and Health Technologies (CNEDiMTS)

gives notice based on criteria defined in the

regulations. The interviews did not highlight any

evidence of criteria specific to high risk MDs. The

requirement level appears to be appropriate to the

clinical context; hence there are more requirements

for high-risk and implantable medical devices.

The Functioning of the Public Sector Was

Pointed Out: hospital procurement procedures are

subject to government rules; the purchasing process

at the hospital is highly complex and lacks visibility

for industrialists.

The indexing of innovative devices in public

health facilities appeared to be structured:

 In short, knowledge about the requirements for

this evaluation may help to guide the right choices

regarding criteria to be evaluated upstream, and

what methods should be used to achieve it.

 Constituting a multidisciplinary indexing

committee proved to be pertinent for evaluating

and validating the purchase of a medical devices:

evaluation of the interest of the medical device

relative to the existing therapeutic arsenal,

evaluation of practices, requirements,

contribution to safety and the level of safety,

intended use, cost (link with the Estimated

Revenues and Expenditures). Clinical studies as

well as publications are involved in the decision-

Practices and Requirements of Stakeholders Involved in the Clinical Evaluation of Innovative High-risk Medical Devices: A Qualitative

Study

333

making. A lack of comparative studies versus the

gold-standard device and links between studies

was revealed; knowledge of the medical device as

a whole remains a real difficulty for end-

users (product lifespan, conditions of re-use,

means of sterilization, evolution of the medical

device...).

 Analyse of various pertinent criteria for

evaluating the quality of the product (the medical

device itself and its packaging) relative to the

medical device retained as a reference, with a

weighting system; the medical advice must

overtake the economical interest only. An official

regulatory decision tree is also interesting for

material vigilance decisions.

A Comparison with Operations in the

Private Sector Appeared to Be Interesting:

 Absence of a tender process or an indexing system

is a difficulty for practitioners; the choice of

medical device seems to be made depending on

available stock, and the sales force.

 Superiority studies and available post-market data

are also insufficient with respect to the ever-

changing nature of surgical equipment.

Material Vigilance Monitoring and Post-

market Studies Were Another Point for Attention:

 For Class III and implantable medical devices the

monitoring plan (PMS = Performance Monitoring

System) is updated at least once a year.

 The particular example of implantable prostheses

was studied: the basic specifications must be

developed, specifying « how many prostheses, at

how many years, with what follow-up, what grid

should we use to evaluate the product The

guidance of the National Institute for Health and

Care Excellence (NICE) are still precise ; in

France, it depends on the experts ».

 Favouring studies in which the University

Hospital is the promotor of the study would allow

the manufacturer to guarantee independence of

data, and favour the publication of negative

results.

 The extent of post-market follow-up (type of

study, duration of follow-up) is confronted with

the principle of reality. It comes down to finding

the right compromise in order to remain within a

reasonable price-range.

The Conclusions Retained are That

Manufacturers Must Present a Clear Process

Regarding Their Claims, to Construct an

Appropriate Clinical Development Plan, so That it

is Possible to Obtain Data on the Clinical Benefits

and Position of the Medical Device in the

Therapeutic Strategy.

3.3.3 Need of Accompaniment and Training

of Stakeholders

 Scientific approaches and methods used to

demonstrate the efficacy of a MD in the current

files have their limits;

 There is a real need for learning, teaching and

accompanying in the construction of a

development plan and at each stage of

development;

 The lack of a global vision and knowledge about

the various stages in the progress of MDs, the lack

of information and referencing of the players to

solicit is presented as difficulty.

 The official guides, supports, summary

documents are difficult to identify.

Awareness of the New Regulation, Training

and Accompaniment of Those Involved Has

Become a Challenge for the Development of

Medical Devices.

4 DISCUSSION

The analysis of all the feedbacks from experiences

showed the complexity of the clinical evaluation of

MDs, particularly when dealing with an innovative,

high-risk MD, “manufacturers have to develop

cutting-edge expertise or deep analysis in very

diverse fields”. Regarding this, emphasis should be

placed on: make the industrials aware of the problem,

strengthen training and developing accompaniment

via specialised platforms, as well as favour

interactions between all those people involved in the

evaluation. “The innovative start-ups succeed if

gathering a set of technical regulatory and clinical

skills”. However, “there is a lack of skills, gateways,

advices and organizations”.

The gathering of clinical data must be reinforced

and anticipated in accordance with the overall

strategy, with the establishment of new adaptive

methodologies responding to the specific

requirements of a medical device evaluation. This

should open a wide range of opportunities to adapt

existing models or create new ones. Real-life data

collection must be amplified and structured with the

contribution of new digital technologies (big data),

opening new fields of research.

The overall strategy of manufacturer must be

anticipated and this should draw on a methodological

procedure based on justifying choices according to

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clinical and therapeutic benefits and the interest of the

various available options and economic models for

public health. Lastly, as part of the reinforcement of

regulatory requirements, regulatory bodies must gain

coherence and homogeneity. It is important to issue

official recommendations. Linkage and structuration

of the players in the sector must be continued, taking

into account all needs in terms of resources (human

resources and expertise) to find the right balance and

continue to innovate.

Within the group of MDs, high-risk devices may

pose a greater risk to patients. Several European

organisms stress the importance to shape, within the

limits of the European legal framework, a coherent set

of rules, procedures, referentials for a guided,

responsible and reasoned maturation process of this

specific kind of MDs (Neyt et al., 2017). This work is

a first step with the gathering of feedbacks from most

of the French stakeholders involved in the process.

The work will be continued by a collection of data at

a more European level as part of a European project

to support and guide stakeholders considering

bottlenecks and strenghts of all the European

countries.

Some biases of the study have been identified.

The biases related to the sample are:

 The profiles of certain protagonists who had more

experience of Class I MDs rather than high-risk

MDs;

 The absence of inclusion of some important

perspectives in the interview panel such as the

end-users (e.g. patients, healthcare professionals),

specialized scientific societies, Notified bodies

and the Commission for the evaluation

(CNEDiMTS).

The biases related to the method are:

 The possible lack of thorough questions about the

methods in the cases of high-risk MDs;

 The study was performed over a short period and

in a highly evolving context. The issues identified

must be regularly put into perspective;

 These results will have to be completed by a

« quantitative » investigation via a new

questionnaire focused on innovative high-risk

MDs;

 Three themes deserve to be addressed to complete

the study: first, the ethical vision (questions about

the risk-benefits ratio, acceptance of the

technology or dependence on it, the choice and

appropriation by the patient or the medical

profession); second, the difficult question of

conflicts of interest among experts; and third, the

unavoidable aspects of intellectual property which

must be mastered right from the beginning.

5 CONCLUSION

This qualitative survey provides a current field

overview of some actors at French national level

regarding the clinical evaluation of MDs. There is a

growing awareness of the need to harmonize actions

around the evaluation of DMs.

Through the different points of view and the

topics addressed, the comments converged to express

the interest of a global evaluation strategy of the MD

and a methodological approach taking into account

the entire maturation cycle and the specific

dimensions of each DM, in particular for high risk

MDs. However, this approach must be strengthened

by the development of methods to capitalize and

combine DM data throughout its life cycle. A better

coordination between public and private actors,

starting from the upstream phases of R&D, will help

researchers, developers, academics, industrials,

pharmacists, hospitals professionals, to conduct first

a prototype to a CE marked product and then a CE

marked product to a reimbursed product.

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