BASG / AGES
Institute Surveillance
Traisengasse 5, 1200 Vienna, Austria
Notification of a Clinical Investigation with a medical device
in accordance with § 40 of the Austrian Medical Devices Act (Medizinproduktegesetz, MPG),
Federal Gazette No. 657/1996 as amended
Please send to:
Bundesamt für Sicherheit im Gesundheitswesen
Institut Überwachung
Traisengasse 5
1200 Vienna, Austria
I.
General information
Clinical investigation identifier:
1. Title/short title and version (number and date) of the Clinical Investigation Plan:
2. Name/description of the medical device intended for clinical investigation (please enter any information necessary
to unequivocally identify the device):
3. Type/description of the medical device intended for clinical investigation:
4. GMDN-Code:
5. Classification of the medical device intended for clinical investigation:
Active implantable medical device (AIMD) = device according to Directive 90/385/EEC
Medical device by risk class = device according to Directive 93/42/EEC
Class I
in accordance with rule
(Annex IX, Directive 93/42/EEC)
Class IIa
in accordance with rule
(Annex IX, Directive 93/42/EEC)
invasive, intended for long-term use
Class IIb
in accordance with rule
(Annex IX, Directive 93/42/EEC)
invasive, intended for long-term use
Class III
in accordance with rule
(Annex IX, Directive 93/42/EEC)
Medical device is an implant
Medical device bears a CE marking
and will be used in accordance with the intended use by the manufacturer
but will not be used in accordance with the intended use by the manufacturer
Medical device is manufactured using tissue of animal origin (see Directive 2003/32/EC)
Medical device contains human blood or blood plasma component(s) (see Directive 2000/70/EC or Directive 2001/104/EC)
F_INS_VIE_CLTR_I203_05
Valid from: 27.05.2014
Page 1 of 6
BASG / AGES
Institute Surveillance
Traisengasse 5, 1200 Vienna, Austria
Notification of a Clinical Investigation with a medical device
in accordance with § 40 of the Austrian Medical Devices Act (Medizinproduktegesetz, MPG),
Federal Gazette No. 657/1996 as amended
Clinical investigation identifier:
6. Detailed information on the medical device intended for clinical investigation: intended use(s), main indication(s),
mode of application:
7. Sponsor:
Company:
Company:
Contact:
Contact:
Street:
Street:
ZIP code/place:
ZIP code/place:
Country:
Country:
Phone:
Phone:
Fax:
Fax:
Email:
Email:
9. Manufacturer:
10. Bill of fees to be sent to (if different from sponsor):
Company:
Company:
Contact:
Contact:
Street:
Street:
ZIP code/place:
ZIP code/place:
Country:
Country:
Phone:
Phone:
Fax:
Fax:
Email:
Email:
11. Planned starting date of the clinical investigation in
Austria:
Month/year (MM.YYYY):
1
8. Representative of the sponsor in Austria or in the EEA1:
12. Planned end date of the clinical investigation in
Austria:
Month/year (MM.YYYY):
The sponsor must be established in one of the contracting parties to the European Economic Area (EEA, see MPG § 3 (5)).
F_INS_VIE_CLTR_I203_05
Valid from: 27.05.2014
Page 2 of 6
BASG / AGES
Institute Surveillance
Traisengasse 5, 1200 Vienna, Austria
Notification of a Clinical Investigation with a medical device
in accordance with § 40 of the Austrian Medical Devices Act (Medizinproduktegesetz, MPG),
Federal Gazette No. 657/1996 as amended
Clinical investigation identifier:
II. Details on the clinical investigation
13. The clinical investigation will be performed in the following setting(s):
inpatient
outpatient
non-hospital–based office
14. Planned number of subjects to be enrolled in the clinical investigation:
in Austria:
in EEA (excl. Austria):
outside the EEA:
15. Will this be a monocentre or multicentre clinical investigation?
monocentre
multicentre
Planned number of investigational sites:
in Austria:
in EEA (excl. Austria):
outside the EEA:
16. List of investigational sites in Austria (for each investigational site, please complete the Supplementary Form for
Clinical Investigations—Investigational Sites2):





17. In which EEA countries (excl. Austria) will the clinical investigation be performed (incl. numbers of investigational
sites and subjects to be enrolled):

Country:
Place:
Number of sites:
Number of subjects:

Country:
Place:
Number of sites:
Number of subjects:

Country:
Place:
Number of sites:
Number of subjects:

Country:
Place:
Number of sites:
Number of subjects:

Country:
Place:
Number of sites:
Number of subjects:
18. Objective or purpose of the clinical investigation:
19. Study design (randomised, cross-over, parallel, single-blind, double-blind, controlled, etc.):
20. Will control groups be included in the clinical investigation?
No
Yes
21. If control groups are included in the clinical investigation, what are they? (Please specify.)
Other medical device:
Medicinal product:
Other comparative standards (e.g., placebo, no treatment):
2
The Supplementary Form for Clinical Investigations—Investigational Sites is available for download from www.basg.at/Medizinprodukte/Formulare.
F_INS_VIE_CLTR_I203_05
Valid from: 27.05.2014
Page 3 of 6
BASG / AGES
Institute Surveillance
Traisengasse 5, 1200 Vienna, Austria
Notification of a Clinical Investigation with a medical device
in accordance with § 40 of the Austrian Medical Devices Act (Medizinproduktegesetz, MPG),
Federal Gazette No. 657/1996 as amended
Clinical investigation identifier:
22. Combined Studies AMG/MPG:
No
Yes; EUDRA-CT number:
23. Are conclusive results from prior clinical investigations with the medical device available?
No
Yes (Please add a bibliography or references.)
24. Please specify any relevant accessories to be used together with the medical device intended for clinical
investigation:
25. Please specify any software applications required for the proper application of the medical device:
26. Does the medical device contain medicinal product components with a supportive function?
No
Yes, which?
27. Is the medical device designed to enable the administration of a medicinal product?
No
Yes, which?
28. Which concomitant treatments/therapeutic measures (procedures, administered medications, etc.) or diagnostic
tests/examinations will be performed exclusively as part of the clinical investigation?
F_INS_VIE_CLTR_I203_05
Valid from: 27.05.2014
Page 4 of 6
BASG / AGES
Institute Surveillance
Traisengasse 5, 1200 Vienna, Austria
Notification of a Clinical Investigation with a medical device
in accordance with § 40 of the Austrian Medical Devices Act (Medizinproduktegesetz, MPG),
Federal Gazette No. 657/1996 as amended
Clinical investigation identifier:
III. The following documents are attached to this notification:
Clinical Investigation Plan
Investigator’s Brochure
German-language instructions for use for medical devices bearing the CE mark
Favourable opinion(s) of the competent ethics committee(s) (“positive vote”)
German-language Patient Information and Informed Consent Form for potential subjects
Confirmation of insurance coverage for the subjects enrolled in the clinical investigation
Written confirmation that the medical device complies with the essential requirements of the applicable Directive
and that all safety precautions for both the subjects enrolled in the investigation and the users have been taken3
Declaration of conformity of the manufacturer
Certificate(s) of notified bodies
Proof of qualification of the clinical investigator(s)
Agreements between the sponsor, monitor, and clinical investigator establishing each party’s responsibilities
Case Report Form (CRF)
Documentation on the construction and manufacture of the device (manufacturing method, sterilisation, etc.)
Results of assessments and technical tests (e.g., biocompatibility4, electrical safety5, etc.)
Results of the risk analysis
List of standards applied in full or in part
Documentation on the safety of components of animal6 or human7 origin
Other documents (please specify):
Clinical investigation identifier:
3
4
5
6
7
Essential requirements: see Directive 90/385/EEC, Annex I, and Directive 93/42/EEC, Annex I
See EN ISO 10993
See standards of EN 60601 series
See Directive 2003/32/EC, MEDDEV Guidelines of the European Commission
See Directive 2000/70/EC or Directive 2001/104/EC
F_INS_VIE_CLTR_I203_05
Valid from: 27.05.2014
Page 5 of 6
BASG / AGES
Institute Surveillance
Traisengasse 5, 1200 Vienna, Austria
Notification of a Clinical Investigation with a medical device
in accordance with § 40 of the Austrian Medical Devices Act (Medizinproduktegesetz, MPG),
Federal Gazette No. 657/1996 as amended
As of May 2011, all clinical investigations with medical devices have to be entered into the European Database of
Medical Devices EUDAMED by a national authority within the European Economic Area (EEA); in Austria, the authority
responsible for doing so is the Austrian Federal Office for Safety in Health Care, BASG. The clinical investigation must
be entered into the database by the very national authority that is first notified of the clinical investigation.
Which national authority within the EEA will be/was the first to be notified of the clinical investigation?
Austria
other authority within the EEA; if applicable declaration of EUDAMED Number
I hereby declare that the information provided above is correct and complete, and I accept the fees payable as set out
in the Fees Regulation of the Federal Office for Safety in Health Care pursuant to the Austrian Health and Food
Safety Act (Verordnung des Bundesamtes für Sicherheit im Gesundheitswesen über den Gebührentarif gemäß
Gesundheits- und Ernährungssicherheitsgesetz (GESG), see www.basg.at/ueber-uns/tarife/).
NEW! The notification of a clinical investigation should be submitted to the competent authority (BASG) as one
paper hardcopy and electronically (CD-ROM or email).
Electronic submission: When submitting your notification per email, please use the official email address of the
Institute Surveillance: inspektionen@ages.at
Stamp of the sponsor
Date, signature and name in capital letters
The study design and documentation are considered to be in agreement with ISO standard EN ISO 14155. The
essential requirements for medical devices are laid down in Annex I of EU Directives 93/42/EEC and 90/385/EEC.
Compliance with these requirements is presumed when the medical device is in conformity with applicable European
harmonised standards.
NOTE:
The clinical investigation notification must be submitted to the Austrian Federal Office for Safety in Health Care
(Bundesamt für Sicherheit im Gesundheitswesen, BASG) before the start of the clinical investigation (see
MPG § 40 as amended).
F_INS_VIE_CLTR_I203_05
Valid from: 27.05.2014
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