CAAmendment object
Substantial amendments to clinical investigations according to MPG § 40 (2) and (3)
Substantial amendments to clinical investigations according to MPG § 40 (2)
Sponsor
Legal representative domiciled in the EU/EEA
Yes
F I200 Amendment Form MPG (en/de): Bilingual amendment form for amendments to clinical investigations and performance evaluations
The amendment application form + additional documentation should be submitted on a data carrier.
35
From date of receipt of valid application
Tacit approval (non- rejection procedure) for amendments to § 40 (2) MPG studies (explicit authorisation also possible)
Yes
L I99 Guidance Document for Clinical Investigations with Medical Devices (en)
L I192 Leitfaden für klinische Prüfung mit Medizinprodukten (de)
Yes
Notification only (without approval process) for § 40 (3) MPG studies: low-risk MDs and performance evaluations of in vitro diagnostic MDs
Approval/ authorization required for § 40 (2) MPG studies : High risk devices (AIMDs, class III medical devices, implantable and long-term invasive medical devices of class IIa or IIb)
Urgent amendments such as the temporary suspension of an investigation for reasons of participant safety or the introduction of additional monitoring measures can be implemented without prior notification to the BASG (§ 40a (5) MPG).
Non-substantial amendments should be documented and brought to the BASG’s attention with the next substantial amendment and do not have to be immediately notified to the BASG with two exceptions:
• Non-substantial changes that relate to the application form should be submitted to the BASG timely to ensure actuality of the database.
• Changes to the protocol required by the ethics committee that relate to the safety monitoring of the patients should be promptly submitted to the BASG.
If a separate notification is desired, the amendment notification form F_I200 should be used.
