Basic Information
Medical Device Information System
r
… Free movement for medical devices inside the European Market: European manufacturer may
bring their products to the market
throughout the EU. For market surveillance of medical devices in Germany, meanwhile nearly 16 Notified Bodies and about 90 Competent Authorities in Germany use the
Medical Device Information System
at DIMDI since 2003.
The information system for medical devices including online-registration-systems
and mailing systems enables the faster notification and work on notifications of me-
r Notification on the first placing of pro-
You find the Information System
dical devices and in-vitro diagnostics and
ducts on the market and on safety offi-
for Medical Devices online:
as well of clinical investigations/perfor-
cers (§§ 25, 30 MPG)
www.dimdi.de – Medical
Devices – MP-Infosystem .
mance evaluations. Today data of more
than 67.000 products of about 6.500 ma-
r Notices on the clinical investigation of nufacturers are registrated in the informa-
medical devices and the performance tion system at DIMDI.
evaluations of in vitro diagnostics
(§§ 20-24 MPG)
Since 2006 DIMDI informs also the European Competent Authorities about restric-
r Information relating to certificates from ting, intermitting or withdrawing of certi-
Notified Bodies (§ 18 MPG)
ficates by German Notified Bodies.
In 2010 the whole information system
r Reports on incidents (§ 29 MPG)
was adapted to the changes of the 4th
Medical Device Act (MPG) and also to the
r Notices on the classification of medical new user interface DIMDI SmartSearch.
devices and the demarcation to other products
The Information System
Public access (fee-based) is offered to
The type and contents of the special me-
some databases of the information system
dical device databases of DIMDI can be
(pursuant to § 25 MPG):
taken from the notifications made by the
manufacturers, the authorised represen-
r Adresses of medical devices and in-
tatives, the importers and the notified bo-
vitro diagnostics
dies pursuant to the Medical Device Act
r Notifications of medical devices
(MPG):
r Notifications of in-vitro diagnostics rr
Reporting Procedure online
Nomenclatures for
Medical Devices
The online-registration-systems enable a
direct input of data by the manufacturer
To support the legal tasks, it is essential
and the authorised representative via in-
to use a standard nomenclature for medi-
ternet and processing by the Competent
cal devices. DIMDI publishes a German-
Authorities electronically.
language version of the Universal Medical
Device Nomenclature System (UMDNS)
The processing of data exchange is en-
on behalf of the Ministry of Health (BMG).
crypted and ensures high data security.
The original English version was develo-
Extensive check routines support the ac-
ped by the scientific institute ECRI, USA.
curate input of data and guarantee a high
The English-language classification of the
You find all information about
European Diagnostic Manufacturer Asso-
the Information System for
The New Medical Devices Information Sy-
ciation (EDMA) is used so far to name in-
Medical Devices online:
stem consists of three areas:
vitro diagnostics. UMDNS and EDMA-clas-
www.dimdi.de – Medical
sification are integrated into the registra-
Devices
degree of data quality.
r Notification of the respective address
tion systems and can be downloaded free
data
of charge.
r Notifications of medical devices and
invitro diagnostics
UMDNS and EDMA-classification shall be
r Applications for clinical investigations/
replaced by the Global Medical Device
performance evaluations
Nomenclature (GMDN). It is included in
the European Database on Medical De-
DIMDI SmartSearch enables data entry
vices (EUDAMED).
using a form with sections arranged like a
register. The last section serves for verifica-
The original English Version of GMDN is
tion: All the entered data is presented and
now in translation into the languages of
can still be edited if necessary.
the EU Member States by the European
Commission in order to guarantee a stan-
When data has been forwarded, all spon-
dard nomenclature for medical devices.
sors and those subject to compulsory notification receive a confirmation email
Other Services at DIMDI
Helpdesk Medical Devices
ethics committee will also be informed of
r Legal wording: The Medical Device mpall@dimdi.de
new incoming notifications/applications.
Act (MPG) with all the regulations and
from DIMDI. The responsible authority or
Tel.: +49 221 4724-522
Vs 100804
bulletins.
Once the responsible authority has regi-
r Adresses of the Competent Autho-
German Institute of Medical
stered the incoming data, it will finally be
rities and the Notified Bodies inclu-
Documentation and Information
released in the database for the involved.
ding their scope of responsibility in The person reporting can search for the
Germany; links to the corresponding
Waisenhausgasse 36-38a
current status of the registered notifica-
addresses of the EEA member states.
50676 Köln
tions and the investigations and evalua-
r Links, e .g to the European Commissi
Germany
tions free of charge.
on, GMDN and Associations, to Euro-
Tel.: +49 221 4724-1
pean Directives and Guidelines, Euro-
Fax: +49 221 4724-444
The access authorisation is password pro-
pean harmonised standards and more.
www.dimdi.de
tected. Access codes for persons obliged
r Free access to the nomenclature sys-
posteingang@dimdi.de
to give notice (pursuant to §§ 20-24, 25
tems to download.
and 30 MPG) can be applied for online
r Additional databases, e.g. literature
via the website of DIMDI - as well as fur-
databases as MEDLINE, EMBASE or
ther details and directions on how to use
SciSearch. s
the different registrations systems.
Within the scope of the