Swissmedic Annual Report 2018

60 Market access | Medical devices
Medical devices
Market surveillance of medical devices
Medical devices encompass an extremely large range of
products, including implants such as hip prostheses and
heart pacemakers, in vitro diagnostics such as HIV or pregnancy
tests, or products for the general public such as contact
lenses. Before these products can be placed on the
market, manufacturers have to carry out and assume responsibility
for their own conformity assessment procedure.
In the case of higher-risk products, an officially accredited
European notified body – a “conformity assessment body”
(CAB) – must also examine the product. Products that meet
the requirements of the assessment procedure are given CE
marking. Swissmedic is responsible both for the surveillance
of medical devices that are already on the market and of
notified bodies in Switzerland. Swissmedic also monitors
and approves clinical trials of medical devices that are not
yet authorised for the market.
Integration within the European system
Swissmedic is integrated into the European system for medical
devices. Switzerland has concluded agreements on the
mutual recognition of conformity assessments for medical
devices with EU Member States, EFTA states and Turkey.
Under this
European system, the authorities of the contracting states
have access to a shared database (EUDAMED) which acts as
a market surveillance information system. CE-marked medical
devices are considered to be compliant and may be
distributed in all contracting states.
Swissmedic is actively involved in the Competent Authorities
for Medical Devices (CAMD) project, the umbrella
group for EU Member States, and its working groups. The
Agency also sits on the CAMD Executive Group (CEG), and
is an observer within the European Commission’s Medical
Device Coordination Group (MDCG) and its working
groups.