1 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 criti- cal 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 21. 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 excel- lent occasion for exchange between representatives of the EU Institutions, companies and trade asso- ciations 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 demo- graphic, societal and scientific challenges. The Chair of the European Parliament’s Committee on the Environment, Public Health and Food Safe- ty, Giovanni LA VIA, echoed the statement and also recognised the important role of citizen empo- werment in the healthcare sector. Conference report Substance-based medical devices: An important part of self-care Brussels, 14-15 October 2015 Conference
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1
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 criti-
cal 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
21.
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 excel-
lent occasion for exchange between representatives of the EU Institutions, companies and trade asso-
ciations 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 demo-
graphic, societal and scientific challenges.
The Chair of the European Parliament’s Committee on the Environment, Public Health and Food Safe-
ty, Giovanni LA VIA, echoed the statement and also recognised the important role of citizen empo-
werment in the healthcare sector.
Co
nferen
ce repo
rt
Substance-based medical devices:
An important part of self-care
Brussels, 14-15 October 2015
Conference
In his welcome to the event, AESGP President, Roger SCARLETT-SMITH, explained the rationale for the con-
ference: 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 pro-
portionality 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
Aurélien 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 Commission’s
Medical Devices Unit, Mr Perez
helped setting the scene as to the
genesis of Rule 21 and the specific
requirements pertaining to subs-
tance-based medical devices. He
notably revealed that a specific
rule for “devices ingested, inhaled
and administered rectally and va-
ginally” was mentioned for the
first time at a specific meeting on
borderline issues which took place
in March 2011 between repre-
sentatives from medical devices
and medicinal products compe-
tent authorities. A number of pro-
ducts such as simethicone pro-
ducts historically classified as me-
dicinal products were discussed at
that meeting, as well as the pecu-
liar case of an anti-lice product
classified in four different catego-
ries in EU Member States.
“Legal certainty
and clarity around
the classification of
substance-based
medical devices is
needed for both
competent
authorities and
manufacturers.”
Aurélien Perez
“The final
responsibility on
the safety of a
medical device
lies on the CEO”
Maikel Hendriks
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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 medi-
cal 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.
“There is a strong difference bet-
ween the intended use of a pro-
duct and the mechanism of ac-
tion of a substance.”
Emiliano Giovagnoni
The Head of the Food and Health Department at the European Consumer Organisation (BEUC), Ilaria PAS-
SARANI, 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.
Emiliano GIOVAGNONI, Director of Regula-
tory Affairs at the Italian company Aboca,
presented the vision of Aboca in the self-
medication sector. It includes the concept of
using different extracts/parts of a plant in
different products: the part containing poly-
saccharides 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 non-
prescription 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 cor-
responds to 56 million units per year (equal
to a 16% market share). More than 500 com-
panies 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.
Meeting report
3
From left to right: Maikel HENDRIKS, Aurélien PEREZ, Ilaria PASSARANI, Roger SCARLETT-SMITH, Emiliano GIOVAGNONI
“Claims made on medical devices
should be substantiated by solid
scientific evidence, not only tested
on a few people.”
Ilaria Passarani
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 Commission’s Directo-
rate-General for Internal Market, Industry, Entrepreneurship and
SMEs (DG GROW) recognised the work done during the recent
Presidencies of the Council of the EU.
Mrs Passarani explained that from her perspec-
tive there is a need for a comprehensive data-
base which should be publicly accessible. For
BEUC, there are concerns that some manufac-
turers 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.
“The new Rule 21 will
need to be clear without
generating any risk of
different interpretation”
Carlo Pettinelli
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Mr Pettinelli gave an overview on the three main
reasons for the recast of the Medical Devices Direc-
tives:
□ 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 pre-
valence of chronic and often multiple di-
seases: one third of the EU population is ex-
pected to develop at least one chronic di-
sease, and
□ the need to provide a strong response to re-
cent scandals.
Scientific and technical progresses such as progress