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Conference report


Substance-based medical devices:

An important part of self-care
Brussels, 14-15 October 2015

From left to right: Hubertus CRANZ, Vytenis ANDRIUKAITIS, Giovanni LA VIA, Roger SCARLETT-SMITH

On 14 and 15 October 2015, the Association of the European Self-Medication (AESGP) held its first
conference specifically dedicated to self-care medical devices in Brussels. The background for the
conference was the debate on the new legislation for medical devices which has now entered its critical phase. AESGP is particularly interested in the future legislative framework for substance-based
medical devices which are covered by a specific rule in the legislative texts under consideration: Rule
The event started with a reception within the premises of the European Parliament, just a few days
after the 50 years celebration of the creation of the pharmaceutical legislation. It provided an excellent occasion for exchange between representatives of the EU Institutions, companies and trade associations in the healthcare and particularly the self-care sector.
In his speech, the European Commissioner for Health and Food Safety, Vytenis ANDRIUKAITIS,
highlighted the importance of self-care, including self-care products, in order to meet future demographic, societal and scientific challenges.
The Chair of the European Parliaments Committee on the Environment, Public Health and Food Safety, Giovanni LA VIA, echoed the statement and also recognised the important role of citizen empowerment in the healthcare sector.

In his welcome to the event, AESGP President, Roger SCARLETT-SMITH, explained the rationale for the conference: a significant increase in products and market share but major challenges for the category through
the new legislation for all medical devices. In such a situation, it is important to follow the principles of proportionality and make sure that new rules do not eliminate products from the market which have not caused
any concerns with regard to public health and are widely regarded as safe. It should also be kept in mind
that important innovations are done in this area which might no longer be possible if the new legislation is
not well drafted.

Session 1: Self-care medical devices: an important part of self-care

Aurlien PEREZ, policy officer
with the Directorate-General for
Health and Food Safety (DG
SANTE), informed the participants
on a number of ongoing self-care
pilot projects on the promotion of
self-care systems in the EU.
In light of his previous position
within the European Commissions
Medical Devices Unit, Mr Perez
helped setting the scene as to the
genesis of Rule 21 and the specific
requirements pertaining to substance-based medical devices. He
notably revealed that a specific

The final
responsibility on
the safety of a
medical device
lies on the CEO
Maikel Hendriks

rule for devices ingested, inhaled

and administered rectally and vaginally was mentioned for the
first time at a specific meeting on
borderline issues which took place
in March 2011 between representatives from medical devices
and medicinal products competent authorities. A number of products such as simethicone products historically classified as medicinal products were discussed at
that meeting, as well as the peculiar case of an anti-lice product
classified in four different categories in EU Member States.

Legal certainty
and clarity around
the classification of
medical devices is
needed for both
authorities and
Aurlien Perez

Meeting report

Two members of the AESGP Medical Devices Committee explained the business activities in this area and
the perspectives for the products under consideration.
Maikel HENDRIKS, CEO of Medical Brands, provided data as to the market size of substance-based medical devices in the Netherlands, which doubled in the past few years. His case study related to urinary tract
infections (UTIs) occurring when Escherichia coli enters the urinary tract through the urethra and multiply
in the bladder drew particular attention. Mr Hendriks believes that innovation in the sector will come from
the development of new self-diagnostic tests which e.g. will help women self-diagnose whether Escherichia
coli is present in their urines and modernise the way UTIs are currently addressed.

Emiliano GIOVAGNONI, Director of Regulatory Affairs at the Italian company Aboca,

presented the vision of Aboca in the selfmedication sector. It includes the concept of
using different extracts/parts of a plant in
different products: the part containing polysaccharides can have a barrier action and may
therefore be used for the development of a
medical device, while the alkaloid fraction has
a pharmacological mode of action resulting in
their classification as a medicinal product. The
flavonoid component may be used in food
supplements and the oil fraction in cosmetics.
Looking at the market development of nonprescription medicinal products and medical
devices in Italy (excluding cosmetics, food
supplements and other product categories),
substance-based medical devices now have a
total turnover of EUR 675 million (which
means 22% market share) in value. This corresponds to 56 million units per year (equal
to a 16% market share). More than 500 companies operate in this market. Ingested
medical devices play a particularly important
role with over 8 million units sold per year
(15% of the total amount) and with a 37%
growth rate, according to Mr Giovagnoni.

There is a strong difference between the intended use of a product and the mechanism of action of a substance.
Emiliano Giovagnoni

The Head of the Food and Health Department at the European Consumer Organisation (BEUC), Ilaria PASSARANI, regretted the long implementation period of the medical devices legislation and the fact that, as a
consequence, a new regulation will not be applicable before 2020. BEUC welcomes the improvement when
it comes to qualification and training of personnel within notified bodies, the more stringent monitoring of
notified bodies by competent authorities and the joint assessment of notified bodies performed by Member
States and Commission Experts.

Mrs Passarani explained that from her perspective there is a need for a comprehensive database which should be publicly accessible. For
BEUC, there are concerns that some manufacturers bypass the food supplements legislation
and classify a product as a medical device. Mrs
Passarani also requested more information for
consumers of substance-based medical devices.

Claims made on medical devices

should be substantiated by solid
scientific evidence, not only tested
on a few people.
Ilaria Passarani

From left to right: Maikel HENDRIKS, Aurlien PEREZ, Ilaria PASSARANI, Roger SCARLETT-SMITH, Emiliano GIOVAGNONI

Session 2: The overall status of the review of the medical

devices legislation
Gesine MEISSNER, Member of the European Parliament and
shadow rapporteur of her political group for the new legislation
on medical devices, chaired the session on the overall status of
the review of the medical devices legislation. She drew attention
to the good timing of the conference just two days after the first
trilogue discussion which took place on 13 October 2015,
Carlo PETTINELLI, Director for Consumer, Environmental and
Health technologies within the European Commissions Directorate-General for Internal Market, Industry, Entrepreneurship and
SMEs (DG GROW) recognised the work done during the recent
Presidencies of the Council of the EU.

The new Rule 21 will

need to be clear without
generating any risk of
different interpretation
Carlo Pettinelli

Meeting report

Mr Pettinelli gave an overview on the three main

reasons for the recast of the Medical Devices Directives:

the need to create a strong and harmonised

EU regulatory framework for medical devices,
and consequently the need for a sustainable
legal framework,
the need to have a legal framework fit for the
new societal changes and the increased prevalence of chronic and often multiple diseases: one third of the EU population is expected to develop at least one chronic disease, and
the need to provide a strong response to recent scandals.

Scientific and technical progresses such as progress

in drug/device combination products, tissue engi-

neering, information and communication technologies (ICT), nanotechnologies/nanoscience, personalised medicines, and genetics are providing new
opportunities for improving healthcare and how
healthcare services are delivered. These developments should be taken into consideration when
looking at a new legal framework for medical devices.
Substance-based medical devices are an ideal case
study: in order to enhance public health, we need
to make sure that these products do not constitute
a risk to patients in terms of possible interactions
with medicinal products and toxicity taking into
account the situation of vulnerable populations
such as the elderly population. Proportionality, and
by that a risk-based approach, should apply to the
classification of substance-based medical devices,
said Mr Pettinelli.

From left to right: Carlo PETTINELLI, Gesine MEISSNER, Vincent HOUDRY, John WILKINSON

The important question is whether a substance-based medical device is

systemically absorbed or not regardless of whether the absorption occurs
for the intended purpose.
Vincent Houdry

Vincent HOUDRY, Health advisor at the Permanent Representation of France to the EU, underlined the
importance of this very technical regulation on medical devices for France. The French Government regrets that we may miss some flexibility once the regulation is adopted. France is committed to finding
an agreement with the European Parliament, whose views are very close to those of France. Regarding
Rule 21, France does not see the necessity to differentiate the risk depending on whether a systemic absorption occurs for the intended purpose of the device or not. But an exception mechanism, e.g. in the
form of a list, would be supported in order to exclude some products, which are low-risk but may still be
absorbed, from a classification in class III.

The industry should remain

careful as to substance-based
medical devices, especially those
ingested considering that they
may interact with other products
such as medicines.
John Wilkinson

As Director of medical devices at the Medicines and

Healthcare products Regulatory Agency (MHRA),
John WILKINSON manages the issues related to the
regulatory framework of medical devices on a daily
basis. Mr Wilkinson thus emphasised the necessity to
ensure that the regulation works not only on paper
and that there are unambiguous rules in place with
specific decision trees. Tremendous work will need to
be done in terms of transitional arrangements and it
remains to be seen if manufacturers wish to see their
products evaluated under the new rules. Eudamed
and UDI have to be established in a way to support
the market surveillance.

The MHRA is currently working with notified bodies to build their capacities in this respect.
Finally, Mr Wilkinson highlighted the need to better work with colleagues from the Medicinal Products
Departments and pointed to the necessity of having a formal forum so as to make adequate co-decisions
across the system.

Session 3: Substance-based medical devices: how to establish

long-term sustainability?
The third session started with an introductory statement from Michle RIVASI, Member of the European
Parliament and shadow-rapporteur on medical devices for the Greens, who explained her top issues as regards the medical devices file: the need for a full liability of manufacturers when patients are harmed by a
faulty medical device, and the strengthening of notified bodies so as to avoid some manufacturers
shopping around for a less rigorous notified body.



Meeting report

The industry position was voiced during the session by a Member

of the AESGP Committee on Medical Devices, Andrew WILSON,
who explained the key AESGP points, namely:

the extension of the Rule 21 scope in the Council text

issues with the definition of the term absorption and
the need for a case-by-case assessment performed through
a transparent and sound scientific process
the need to delete the cross-reference between two different
sets of legislation
greater consistency of application from the outset through
harmonised standards or even through new Common Technical Specifications (CTS)
clarity and proportionality concerning Rule 19 on nanomaterials
the need to look more precisely at the transitional arrangement (Article 94)
no automatic exclusion from the scope of biological substances such as lactobacilli

AESGP supports the

position of the European
Parliament as to a
deletion of Rule 21. The
proposed Rule is difficult
to interpret, no doubt
leading to differences
across Member States
and differences in
Andrew Wilson

Judite NEVES, Director at the Health Products Directorate of the Portuguese Competent Authority (Infarmed) explained that
from her perspective, there should be a
better understanding as to the concept of
pharmacological, immunological and metabolic means across the medical devices
and medicinal products sectors.

Judite NEVES

Council Compromise
New classification Rule (21)
If are systemically absorbed in order to achieve the
intended purpose;


Classe III

If are intended to be introduced into the gastrointestinal

tract and are systemically absorbed;
Other cases, except if intended to be applied on skin;

Classe IIb

Applied on skin

Classe IIa

Portugal considers that Rule

21 can be improved in some
aspects. For us and other
delegations, substances
applied in the nasal cavity
and oral cavity as far as the
pharynx could be classified in
class II a.
Judite Neves

Maria Grazia LEONE, Ministry of Health, Italy

addressed three main points:

Rule 21
Tools to treat borderline cases
Advertising of medical devices in Italy

According to Mrs Leone, Rule 5 of the Medical

Device Directive 93/42/EC is intended for all invasive devices with respect to body orifices, so it
is difficult to classify substance-based medical
devices based on this Rule. Therefore Italy supports the establishment of a new rule 21. When
Maria Grazia LEONE
looking at the current proposal of the Council for
Rule 21, it should be kept in mind that some countries were willing to exclude the products under consideration from the scope, which would mean that none of them could be classified as medical device any longer.
Is safety really a major issue for substance-based medical devices? Probably not said Mrs Leone, and all
issues could be addressed through the enhanced clinical and post-market requirements and audits performed by notified bodies. Most of the safety studies conducted under the ISO harmonised standards 10993
are similar to those under Module 4 of Annex I of the Medicinal Products Directive.
Mrs Leone also explained that the functioning of the so-called Helsinki Procedure was created in 2002 during a meeting of Competent Authorities for Medical Devices in Helsinki to allow exchange of information
and opinions between National Competent Authorities from the then 15 EU Member States, EFTA countries
and Turkey on the classification of a product as a medical device or not.
In this context, Miranda MOUSSA, Manager
for Medical Devices at AESGP, drew attention
on the lack of involvement of manufacturers in
the Helsinki Procedure, which has led to decisions not reflecting the full knowledge of products under consideration. Representatives
from National Authorities agreed that the current procedure is not functioning in a perfect
manner and that it is necessary that the contributions of concerned manufacturers and notified bodies be better integrated in the decision making.
Miranda MOUSSA

Matthias NEUMANN, Ministry of Health, Germany, explained how long-term sustainability

may be established for substance-based medical devices.

Miranda MOUSSA

Mr Neumann underlined that no vigilance

cases do not necessarily mean that the product is safe. In case a person is treated with
an ineffective product, it means that this person misses the opportunity of being treated by
another product. Therefore, this can be considered as an unsafe use.
Matthias NEUMANN

Meeting report

in business
means being
open to
changes: this
is what
should do

The difficulty to draw a line between medicinal products and medical devices does not justify the blunt
classification in class III of all substance-based medical devices, and this is considered as an overregulation
by the German Ministry of Health. said Mr Neumann.
Proper attention should also be brought to Rule 13 proposed by the European Commission [All devices
incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal
product, as defined in Article 1 of Directive 2001/83/EC, including a medicinal product derived from human
blood or human plasma, with action ancillary to that of the devices, are in class III].
Mr Neumann noted that the second indent of Rule 21 as proposed by the Council and classifying all devices intended to be used in the gastrointestinal tract as class III is probably going a bit too far.

SESSION 4: Making the new system work in reality

In the last session of the day, Mairead MCGUINNESS, Vice-President of the European Parliament and shadow-rapporteur for the EPP group on the proposal for a regulation on medical devices, revealed further
information on the first trilogue discussions which took place two days before the conference. Different
positions were exposed concerning Rule 21 and a compromise wording has to be reached at the next
round of discussions. The European Parliament is well aware of and familiar with the concerns highlighted
by AESGP with regard to the Council position. Mrs McGuinness underlined the need to have clarity around
this issue. Guiding principles for the final decision should be patient safety and innovation.

While not being the most complex issue in the medical devices regulation,
Rule 21 is a challenging point.
Mairead McGuinness

From left to right:: Hubertus CRANZ, Mairead MCGUINNESS, Gert BOS

Quite a few notified bodies have more than one pharmacist in-house, which
may well be the requirements for a notified body to be able to assess
substance-based medical devices against Annex I of Directive 2001/83/EC.
Some notified bodies have personnel who used to work within Drug Agencies.
Gert Bos

Gert BOS, President of The

European Association for Medical devices of Notified Bodies
(TEAM-NB), explained that, from
his perspective, all inputs from
manufacturers, including technical (clinical investigations, medical literature review, and implants
marketing (customer surveys,
post-market study,) as well as
quality control, should be integrated in the post-market surveillance plan.
The proposal of the European
Parliament to have Special Notified Bodies designated by the
European Medicines Agency
(EMA) bears the risk that manufacturers may bluntly go to
these bodies and not to the
other ones. It should also be
clearly stated in advance what
the roles of different notified


bodies will be. Joint audits are

currently ongoing (60 man-days
audits, which means 12 auditors
during 5 days). These audits are
appreciated by notified bodies
as they give them assurance and
During unannounced audits,
non-conformities were hardly
found, which confirms that the
system is working well.
CRANZ, Director
General of the Association of
the European Self-Medication
Industry, drew attention to the
need for adequate transitional
arrangements and appreciated
that some specific proposals
have now been integrated in the
Council position. Concerning
Rule 21, it was recognised that
there are strong views in the
Council in favour of such a

provision. From an AESGP perspective, current rules do not put

in question the safety of substance-based medical devices
and do not necessarily have to
be changed. The final decision
concerning this rule will be a
political one.
AESGP is committed to continuing to provide information on
this category to the EU institutions so that a balanced and
proportionate regulation can be

No industry can build

a business on a
category of products
that is unsafe.
Hubertus Cranz