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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

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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

in drug/device combination products, tissue engi-

neering, information and communication technolo-

gies (ICT), nanotechnologies/nanoscience, persona-

lised medicines, and genetics are providing new

opportunities for improving healthcare and how

healthcare services are delivered. These develop-

ments should be taken into consideration when

looking at a new legal framework for medical de-

vices.

“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

Meeting report

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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 re-

grets 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 ab-

sorption 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 Michèle RIVASI, Member of the European

Parliament and shadow-rapporteur on medical devices for the Greens, who explained her top issues as re-

gards 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.

Michèle RIVASI Andrew WILSON

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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

“systemic”

□ 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 Tech-

nical Specifications (CTS)

□ clarity and proportionality concerning Rule 19 on nanomate-

rials

□ the need to look more precisely at the transitional arrange-

ment (Article 94)

□ no automatic exclusion from the scope of biological subs-

tances 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

opinion.”

Andrew Wilson

Judite NEVES, Director at the Health Pro-

ducts Directorate of the Portuguese Com-

petent Authority (Infarmed) explained that

from her perspective, there should be a

better understanding as to the concept of

pharmacological, immunological and me-

tabolic means across the medical devices

and medicinal products sectors.

“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

Judite NEVES

• If are systemically absorbed in order to achieve theintended purpose;

• If are intended to be introduced into the gastrointestinaltract and are systemically absorbed;

• Other cases, except if intended to be applied on skin;

• Applied on skin

New classification Rule (21)Risk

Classe IIb

Classe IIa

Classe III

-

+

Council Compromise

Meeting report

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Maria Grazia LEONE

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 in-

vasive devices with respect to body orifices”, so it

is difficult to classify substance-based medical

devices based on this Rule. Therefore Italy sup-

ports the establishment of a new rule 21. When

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 conside-

ration from the scope, which would mean that none of them could be classified as medical device any lon-

ger.

“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 per-

formed 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 du-

ring 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 deci-

sions not reflecting the full knowledge of pro-

ducts under consideration. Representatives

from National Authorities agreed that the cur-

rent procedure is not functioning in a perfect

manner and that it is necessary that the contri-

butions of concerned manufacturers and noti-

fied bodies be better integrated in the deci-

sion making.

Matthias NEUMANN, Ministry of Health, Ger-

many, explained how long-term sustainability

may be established for substance-based medi-

cal devices.

Mr Neumann underlined that “no vigilance

cases do not necessarily mean that the pro-

duct is safe”. In case a person is treated with

an ineffective product, it means that this per-

son misses the opportunity of being treated by

another product. Therefore, this can be consi-

dered as an unsafe use.

Miranda MOUSSA

Matthias NEUMANN

Miranda MOUSSA

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“Long-term

sustainability

in business

means being

open to

necessary

changes: this

is what

industry

should do“

Matthias

Neumann

“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 de-

vices intended to be used in the gastrointestinal tract as class III is probably going a bit too far.

“While not being the most complex issue in the medical devices regulation,

Rule 21 is a challenging point.”

Mairead McGuinness

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 sha-

dow-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.

Meeting report

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

Gert BOS, President of The

European Association for Medi-

cal devices of Notified Bodies

(TEAM-NB), explained that, from

his perspective, all inputs from

manufacturers, including techni-

cal (clinical investigations, medi-

cal literature review, and im-

plants registries), sales/

marketing (customer surveys,

post-market study,) as well as

quality control, should be inte-

grated in the post-market sur-

veillance plan.

The proposal of the European

Parliament to have Special Noti-

fied Bodies designated by the

European Medicines Agency

(EMA) bears the risk that manu-

facturers 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

stability.

During unannounced audits,

non-conformities were hardly

found, which confirms that the

system is working well.

Hubertus 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 pers-

pective, current rules do not put

in question the safety of subs-

tance-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 conti-

nuing to provide information on

this category to the EU institu-

tions so that a balanced and

proportionate regulation can be

established.

“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

“No industry can build

a business on a

category of products

that is unsafe.”

Hubertus Cranz

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