L I103 ENG Überprüfung der Anwendbarkeit von 40 5

advertisement
BASG / AGES
Institute Surveillance
Traisengasse 5, 1200 Vienna, Austria
Clinical investigations/performance evaluations in accordance with § 40 (5) of the Austrian
Medical Devices Act (Medizinproduktegesetz, MPG), Federal Gazette No. 657/1996 as amended
by Federal Gazette I No. 143/2009
Definitions in accordance with MPG § 3
(2) “Clinical investigation” is any systematic study of a medical device other than an in vitro
diagnostic medical device which is performed in study participants for the purpose of
1. obtaining performance data pertaining to the medical device or verifying whether the
performances of the medical device when used as intended are in agreement with the
performance data specified by the manufacturer or other sponsor,
2. assessing whether any undesirable side effects that may occur during normal conditions of use
constitute, in terms of their type, severity, and frequency, an acceptable risk when weighed
against the performances intended, or
3. determining mechanisms of action and suitable clinical indications of the medical device,
to assess the safety and effectiveness of the medical device.
(2a) “Performance evaluation” is any systematic study of an in vitro diagnostic medical device in
medical laboratories or other suitable institutions which is performed on samples obtained from
study participants, including blood and tissue samples, for the purpose of
1. obtaining performance data pertaining to the in vitro diagnostic medical device or verifying
whether the performances of the in vitro diagnostic medical device when used as intended are in
agreement with the performance data specified by the manufacturer or other sponsor,
2. assessing whether any risks that may occur during normal conditions of use constitute, in terms
of their type, severity, and frequency, an acceptable risk when weighed against the performances
intended or
3. determining assessment options and suitable medical indications of the in vitro diagnostic medical
device, to assess the safety and effectiveness of the in vitro diagnostic medical device.
Medical Devices Act (MPG) § 40 (5)
Clinical investigations with medical devices in accordance with Directive 93/42/EEC that are authorized to
bear the CE mark in accordance with § 15 may commence after the competent ethics committee has
issued a favourable opinion, provided that the clinical investigation does not use the device for a purpose
other than that referred to in the relevant conformity assessment procedure and that the clinical
investigation does not require any additional diagnostic or therapeutic measures to be taken.
Performance evaluations with in vitro diagnostics in accordance with Directive 98/79/EC that are
authorized to bear the CE mark in accordance with § 15 may commence after the competent ethics
committee has issued a favourable opinion, provided that the performance evaluation does not use the
device for a purpose other than that referred to in the relevant conformity assessment procedure. § 47
shall not apply.
MPG § 40 (5) applies to:


Clinical investigations with medical devices in accordance with Directive 93/42/EEC and
Performance evaluations with in vitro diagnostics in accordance with Directive 98/79/EC
MPG § 40 (5) does NOT apply to clinical studies with active implantable medical devices (AIMDs) in
accordance with Directive 90/385/EEC.
MPG § 40 (5) applies under the following conditions:
MD/IVD carries the CE mark
MD/IVD is used for the intended purpose as specified in the conformity assessment
Clinical investigation of the MD does not require any additional diagnostic or therapeutic
measures
o Favourable opinion (‘positive vote‘) by the ethics committee available
Relevant changes to the intended purposes of a given medical device as specified in the conformity
assessment include other or additional indications, patient populations, and disease severities or stages;
o
o
o
L_INS_VIE_CLTR_I103_02
Valid from: 30.05.2014
Page 1 of 2
BASG / AGES
Institute Surveillance
Traisengasse 5, 1200 Vienna, Austria
Clinical investigations/performance evaluations in accordance with § 40 (5) of the Austrian
Medical Devices Act (Medizinproduktegesetz, MPG), Federal Gazette No. 657/1996 as amended
by Federal Gazette I No. 143/2009
combinations with other medical devices; use of the device in the context of other or modified medical
procedures; other users (e.g., lay persons); other environmental conditions; or other changes with regard
to the intended purpose of the device.
In the case of full conformity with the CE mark, the notification requirements to BASG and the specific
insurance requirements in accordance with § 47 do not apply; all other provisions regarding clinical
investigations or performance evaluations, including any procedural provisions, remain applicable.
Advantages of MPG § 40 (5) applicability:
o
o
No patient injury insurance (§ 47 MPG) required
No notification to BASG required
Determining the applicability of MPG § 40 (5):
Sponsors may request an official written statement from the BASG confirming that § 40 (5) is applicable
in a particular situation. The documents submitted for the purpose of obtaining a statement regarding the
applicability of § 40 (5) will be assessed based on time available. In cases where § 40 (5) is found to
apply, no fees will be charged.
Please send your written requests for a statement on the applicability of § 40 (5) to
Bundesamt für Sicherheit im Gesundheitswesen (BASG)
Institut Überwachung
Traisengasse 5
1200 Vienna, Austria
or to the official email address of the Institute Surveillance: [email protected]
Documents to be submitted:
Notification forms F_I202 and F_I204 or the complete ethics committee application
 Clinical investigation/evaluation plan or detailed study synopsis, including complete information
on study objectives, study measures, and study examinations
 Instructions for use of the medical device in German
 Conformity statement of the manufacturer, certificates from notified bodies, details on the
intended use(s) of the medical device or in vitro diagnostic medical device as specified in the
conformity assessment
Serious adverse events from studies in accordance with MPG § 40 (5):
The requirements on the notification of serious adverse events in clinical investigations with medical
devices as specified in Directive 2007/47/EC, Annex X—2.3.5, were transposed into § 42 (8) of the
Austrian Medical Devices Act (MPG) as of 21 March 2010. The changes implemented into Austrian law
include a more detailed presentation of the notification requirements for sponsors. No legal exceptions to
the notification requirements as specified in MPG § 42 (8) were defined for investigations which, in
accordance with MPG § 40 (5), do not have to be notified to the BASG. The notification requirements
specified in MPG § 70 (medical devices vigilance) remain unaffected (see also MPG § 61).
For the assessment of serious adverse event reports from non-notifiable investigations (no study
declaration), the BASG has established appropriate risk-based processes.
For more information and forms, please go to:
http://www.basg.gv.at/en/medical-devices/clinical-trials/sae-reporting/
L_INS_VIE_CLTR_I103_02
Valid from: 30.05.2014
Page 2 of 2
Download