Clinical data requirements for EC certificate extension Med

Med-Info
International expert information
for the Medical Device industry
Clinical data for EC certificate extension
shall include:
1. A
recent update of the “state of the art” review:
1.1 A
documented, systematic literature review (not
older than 6 months at time of submission to ensure
it covers the most recent available data) according
to the requirements as outlined in MEDDEV 2.7.1,
including a protocol for identification, selection,
collation, and review of relevant publications
comprising search terms, data bases, criteria
for inclusion/exclusion of particular references
1.1.1 to enable a thorough review of the current “state
of the art” as described below. It is recommended
to chose a two-stage approach with regard to
the conduct of the literature search, i.e. start
with a general literature search, which covers all
indications to be treated with the device under
assessment, followed by a concentrated search
focusing on the device under assessment and
competitor/comparable devices.
1.2 Review of the current “state of the art” is to
be understood as a detailed discussion about
limitations and benefits of:
TÜV SÜD Product Service GmbH
Clinical data
requirements for
EC certificate extension
ll current therapeutic alternatives (including
1.2.1 A
surgical/non-surgical/conventional/medicinal
options) for the same specific indications/
medical conditions which shall be treated/
diagnosed through the assessed device
1.2.2 C
ompetitor/comparable products used for the
treatment the assessed device is indicated for
1.3 A
justification whether, and if yes, why the assessed
device can in future be regarded to be in compliance
with the “state of the art“.
2. A thorough and critical evaluation of the available
postmarket experience:
2.1 Marketing period
2.2 Number of devices sold
2.3 Number and type of complaints
2.4 Number and type of incidents
2.5 Corrective actions (if yes, which?)
2.6 P
ostmarket clinical follow-up studies (in case data
from a PMCF-Study are available the Study Plan and
[Interim-] Study Report shall be provided as well as
other applicable study documentation such as the
vote of the Ethics Committee and approval letters
issued by respective authorities)
2.7 Registries
2.8 L ong-term follow-up of pre-market clinical studies
2.9 A pure description of the postmarket experience
might not be adequate. A critical evaluation of
the data/information is needed with regard to
acceptability for certain complications/complaints,
and complication/complaint rates from a clinical
point of view is needed. This is applicable not only for
device-related complications/complaints but also for
procedure-related complications/complaints.
4. A
current version of the risk analysis, taking into
account any issues related to clinical safety and
side effects detected after market release.
Your contact partner at TÜV SÜD Product Service
can provide further information.
Dr. Bassil Akra
Phone: +49 89 5008-4421
Email: [email protected]
If any item is not applicable, this shall be stated.
TÜV SÜD Product Service GmbH, Medical and Health Services, Ridlerstr. 65, 80339 Munich
www.tuev-sued.com/medinfo
Med-Info October 2014/01 EU
3. A
current version of the instructions for use, including
indications/contraindications, risks/side effects and an
update if required. The content of the instructions for
use shall be in consistence with the complete technical
documentation.
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