Professional Documents
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Conference
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
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 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.
The final
responsibility on
the safety of a
medical device
lies on the CEO
Maikel Hendriks
Legal certainty
and clarity around
the classification of
substance-based
medical devices is
needed for both
competent
authorities and
manufacturers.
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.
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.
From left to right: Maikel HENDRIKS, Aurlien PEREZ, Ilaria PASSARANI, Roger SCARLETT-SMITH, Emiliano GIOVAGNONI
Meeting report
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
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 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.
Michle RIVASI
Andrew WILSON
Meeting report
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;
Risk
+
Classe III
Classe IIb
Applied on skin
Classe IIa
Rule 21
Tools to treat borderline cases
Advertising of medical devices in Italy
Miranda MOUSSA
Meeting report
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 devices 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
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
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