./.WORLD TRADE
ORGANIZATIONG/TBT/Notif.99.322
9 July 1999
(99-2841)
Committee on Technical Barriers to Trade
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:  BELGIUM
If applicable, name of local government involved (Articles 3.2 and 7.2):  Belgium
2. Agency responsible:
Ministry of Public Health and the Environment
Health Protection Administration
Inspectorate of Pharmaceutical Products
Cité Administrative de l'EtatQuartier Vésale
Boulevard Pachéco 19/5
B-1010 Brussels
Tel.: +32 2 210 63 58
Fax: +32 2 210 48 80
Agency or authority designated to handle comments regarding the notification shall be
indicated if different from above:           
3. Notified under Article 2.9.2 [ X ], 2.10.1 [    ], 5.6.2 [    ], 5.7.1 [   ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Single-use medical
devices and reusable medical devices
5. Title, number of pages and language(s) of the notified document:  Royal Order on the
Single Use and Re-Use of Medical Devices and Active Implantable Medical Devices
6. Description of content:
The draft calls for:
-         The description "single use" or "non-reusable" on the labelling and in the instructions
to be justified and validated by the manufacturer and subsequently verified by anotified body;
-         the information provided by the ma nufacturer of class 1 devices intended for re-use,
in the context of the essential requirements of Annex I, para 13.6 (h) of the RO of
18/3/99, to be validated by the manufacturer and the contents to be verified by a
notified body.
Key words:  medical device, single use, reusable, active implantable, essential requirements,
notified body, manufacturer.G/TBT/Notif.99.322
Page 2
7. Objective and rationale, including the na ture of urgent problems where applicable:
The question of the re-use of single-use devices in hospital environments needs to be
addressed urgently in order to make possible the unambiguous application of the provisions
of the RO on the transposition of Dire ctives 90/385/EEC and 93/42/EEC and the
safeguarding of public health.
The draft is justified by the concern to guarantee and preserve public health and to
ensure an equivalent level of protection for all patients by making the concept of single use
totally reliable. Likewise, the instructions accompanying reusable class 1 devices must
contain validated and verified information concerning re-use and, more especially, cleaning,
disinfecting and sterilization, as well as continued effectiveness. Whatever the class of
device, these operations expose patients to risk if the instructions are incomplete or
inappropriate.
8. Relevant documents:   -
9. Proposed date of adoption:
Proposed date of entry into force: }60 days
10. Final date for comments:
11. Texts available from:  National enquiry point [ X ] or address, e-mail and telefax
number of the other body:  CIBELNOR