14-15

Brussels

October
2015

Substance-based medical devices:

An important part of self-care

ASSOCIATION OF THE EUROPEAN

SELF-MEDICATION INDUSTRY

PROGRAMME
Objectives
Three years after the publication of the European Commissions proposal for a regulation on medical
devices in September 2012, the discussion on the new legal provisions has made considerable progress.
The European Parliament and the EU Member States have taken their positions. These include considerations for the new requirements specific to self-care medical devices, and particularly devices composed of
substances or combination of substances (substance-based medical devices).
In autumn 2015, the medical devices legislation will be negotiated between the co-legislators: the European Parliament and the EU Member States. It will be essential to adapt the new rules to the needs and
expectations of patients and consumers, and to ensure an adequate availability of all types of medical
devices, including self-care medical devices. It is also important to remember that an objective of the new
legislation is to allow industry to bring safe, effective and innovative products to the market as quickly
and efficiently as possible.
Understanding the particularities of self-care medical devices is a prerequisite to discussing the new legal
framework and to avoiding unnecessary regulatory delays while making sure that the most suitable regulatory framework is applied.
In line with these principles, the aims of the conference will be to provide information on the self-care
medical devices sector, and allow a frank exchange of views on the current and future legislative and
regulatory environment of self-care medical devices between representatives of the European Parliament,
the EU Member States, the European Commission, consumer organisations, industry and other important
stakeholders including notified bodies.
The sessions of the conference will cover the general framework as well as relevant details of the future
legislation of substance-based medical devices. Participants will get a good understanding of the future
market conditions which will facilitate an adequate planning of their activities.

Wednesday, 14 October 2015

18.30 - 21.30

RECEPTION & BUFFET DINNER IN THE EUROPEAN PARLIAMENTS

SALON DES MEMBRES
60 rue Wiertz, Brussels

19.00

Welcome by
Giovanni La Via, Chair, Committee on the Environment,
Public Health and Food Safety, European Parliament
Vytenis Andriukaitis, European Commissioner for Health
Roger Scarlett-Smith, President AESGP

Thursday, 15 October 2015

09.00

MEDICAL DEVICES: AN IMPORTANT PART OF SELF-CARE

Panel discussion with the participation of:

Matthias Groote, Member of the European Parliament

Maria Iglesia-Gomez, Head of Unit, DG SANTE, European Commission

Maikel Hendriks, CEO, Medical Brands

Emiliano Giovagnoni, Regulatory Affairs Director, Aboca

Ilaria Passarani, Head of the Food and Health Department, European

Consumer Organisation (BEUC)

10.30
11.00

Coffee / Tea break

THE OVERALL STATUS OF THE REVIEW OF THE MEDICAL DEVICE LEGISLATION
Panel discussion with the participation of:

Gesine Meissner, Member of the European Parliament

Carlo Pettinelli, Director, DG GROWTH, European Commission

Jean-Pierre Labe, Permanent Representation of Luxembourg to the EU

Catherine Choma, Ministry of Social Affairs, Health and Womens Right,

France

John Wilkinson, Director of Medical Devices, Medicines and Healthcare

products Regulatory Agency (MHRA), United Kingdom

12.30
14.00

Lunch
SUBSTANCE-BASED MEDICAL DEVICES: HOW TO ESTABLISH LONG-TERM SUSTAINABILITY?
Panel discussion with the participation of:

Michle Rivasi, Member of the European Parliament

Judith Neves, Director, Health Products Directorate, Infarmed, Portugal

Maria Grazia Leone, Ministry of Health, Italy

Matthias Neumann, Ministry of Health, Germany

Andrew Wilson, Member of the AESGP Committee on Medical Devices

16.00
16.30

Coffee / Tea break

MAKING THE NEW SYSTEM WORK IN REALITY
Panel discussion with the participation of:

Mairead McGuinness, Vice-President of the European Parliament

Gert Bos, President, The European Association for Medical devices of Notified
Bodies (TEAM-NB)

17.30

Hubertus Cranz, Director General, AESGP

Farewell drink

Hotel information
The Renaissance Hotel
19, rue du Parnasse, Brussels
Phone:
+32 2 505 2500
Fax:
+32 2 505 2473
Email:
brussels.reservations@marriott.com
Room reservations can be made through aesgp.eu/bru15
under Practical Information.
The room rate is per night and includes breakfast. The city tax of
7,58 per night is excluded.
The rates are valid for reservations made until 29 August 2015;
after this date rates are no longer guaranteed and rooms are attributed upon availability.

Registration fee: 500

The fee covers the reception and dinner on 14 October and the
conference, lunch and farewell drink on 15 October 2015. Please
note that AESGP does not accept credit card payments.
Registration can be made online or using a form that can be
downloaded on the conference website. We recommend registration before 25 September 2015.
Cancellations
For cancellations received after 5 October 2015, the whole fee is
withheld.
Updated information on the conference programme will be provided at aesgp.eu/bru15

Room rates
Deluxe single room:
199.00
Deluxe double room:
219.00

The conference will start on

Wednesday, 14 October 2015
with a reception and buffet
dinner in the European Parliament. For those without a
permanent access pass to the
European Parliament and
wishing to attend the reception, please make sure to
complete the corresponding
fields in the registration form
AND to bring your identity
document
(ID
card
or
passport) on the day of the
reception. It will be requested
at the Parliaments entrance.
The Renaissance Hotel, where
the meeting on 15 October
will take place, is in a short
walking distance from the
European Parliament.

Conference secretariat
AESGP
7 avenue de Tervuren
B-1040 Brussels, Belgium
Tel: +32 2 735 51 30
Fax: +32 2 735 52 22
E-mail: info@aesgp.eu

Self care: The first choice in healthcare