Swissmedic Annual Report 2018

Market access | Medical devices
61
Placing on the market
Manufacturers of medical devices that entail an elevated
level of risk must have the conformity assessment of their
products carried out by an officially accredited notified
body. Certain medical devices are subject to mandatory notification.
Swissmedic receives the notifications for such
products, checks them at random to ensure the products
have been correctly classified, issues instructions to make
corrections where necessary, and records the notifications
in the European EUDAMED database.
651
262
Activities
• 651 notifications under Art. 6 para.1 MedDO were
received. The notifications concerned classic Class 1
medical devices, custom-made classic or active implantable
medical devices, systems and treatment units. Class
1 products include devices such as reusable surgical
instruments, adhesive plasters and rolling walkers.
• A total of 262 notifications under Art. 6 para. 2 and
para. 2bis MedDO were submitted for in vitro diagnostic
(IVD) devices.
• Eight notifications in accordance with Art. 6 para. 3
MedDO were received for classic and active implantable
medical devices made using or containing devitalised
human tissue. In addition, 22 change notifications
concerning devitalised human tissue were processed.
• In 33 cases, Swissmedic rejected companies’ notifications
of medical products because the products had
been incorrectly categorised or classified, or because
they did not fall within its area of responsibility.
• In 2018, Swissmedic took part in 14 EU enquiries on
delimitation questions regarding the classification of
devices.
• Swissmedic can issue special permits to import
non-compliant medical devices if such devices could
resolve a life-threatening situation faced by a patient.
24 applications were reviewed.
2018
414
128
2017
33 14 24
27 15 30
Class I notifications
IVD notifications (Switzerland)
Notifications rejected
EU enquiries
Applications for special permits
373
88
2016
49
14 34