Swissmedic Annual Report 2018

64 Market access | Medical devices
Monitoring of conformity assessment
bodies (CABs) and inspections
Swissmedic monitors the Swiss CABs in collaboration with
the Swiss Accreditation Service (SAS), awards them notified
body designation, inspects them, collects their reports on
certificates issued, and records these in EUDAMED. Swissmedic
takes part in quality assurance measures carried out
by the European authorities that appoint notified bodies,
and carries out other inspections in connection with medical
devices.
Activities
• 17 Swiss companies were inspected on an ad hoc basis
as part of market control activities.
• Swissmedic inspected reprocessing, maintenance and
reporting systems in a total of 20 hospitals.
• The Agency coordinates inspections carried out in
Switzerland by foreign authorities and, if needed,
accompanies the inspectors on site.
2018 2017 2016
CAB inspections (excluding ISO 13485) 3 6 3
Number of CABs in Switzerland 2 2 2
Joint assessments 3 2 2
On-site inspections of clinical investigations 1 2 6
Hospital inspections (reprocessing, maintenance and reporting system) 20 26 12
Foreign inspections 45 50 74
Inspections of market controls 17 14 10
Inspections on behalf of the Swiss Accreditation Service (SAS)
as specialist inspector
5* n/a n/a
Export certificates
Swiss companies can order export and manufacturing certificates
for medical devices from Swissmedic. The certificates
issued by Swissmedic confirm that the products in
question are lawfully marketed in Switzerland. Foreign authorities
may require export certificates as a precondition
for importing devices into their country.
Activities
• A total of 2,622 export certificates were issued.
• A new practice for issuing export certificates for medical
devices was introduced in autumn 2018. Associated
with this was the changeover to electronic submission
of order documents via the Swissmedic Portal.
2622 3039 2677
Appeals procedure regarding the market
surveillance of medical devices
Appeals against official decisions taken by Swissmedic may
be lodged with the Federal Administrative Court within 30
days. That Court’s judgement may in turn be contested before
the Federal Supreme Court.
Activities
• Appeals were lodged with the Federal Administrative
Court against four official decisions by the Agency in
connection with the market surveillance of medical
devices. One appeal was not admitted and another was
dismissed, while the remaining two are still pending.
• Of the appeals already pending before the Federal
Administrative Court at the beginning of 2018, one was
rejected. One appeal was dismissed.
2018 2017 2016