Approvals

The current status of the approval process at the 12 SafeBoosC sites:

S: submitted A: approved n/a: not applicable


SiteEthicsMedicinesDevice
ATAn/aA
BEAn/a n/a
CHSn/aA
DEAn/an/a
DKAn/aA
ESAn/an/a
FRAn/aA
IEAn/an/a
ITAn/an/a
NLAn/an/a
SEn/a
UKAn/an/a

Details 
June 28th 2012
August 02nd 2012


No need for approval from ​​Drug Ag​ency

SafeBoosC involves the use of medicines (vasopressors, inotropes, and cyclooxygenase inhibitors). The Danish Health and Medicines Authority (previously Danish Medicines Agency) reviewed the protocol and considered it not to need approval. The concept may have been that SafeBoosC is a study using 'drug-as-a-tool'.


Approval from Device​ Agency in DK

SafeBoosC involves the use of medical devices (near-infrared spectroscopy-based cerebral oximetry, as well as routine clinical monitoring). The Danish Health and Medicines Authority (DHMA) considered that SafeBoosC needed approval since RH-NEO will use the INVOS device with the adult sensor and since this combination is not CE-marked for use in patients under 2.5 kg. The manufacturer of the INVOS device, however, provided us with a statement that this combination complies with all essential (safety) requirements, except for the aspects under study, i.e. the use of the values obtained, to help us getting approval of SafeBoosC. The approval​ has been granted. The NIRO200nx is CE marked for clinical use, without restrictions on type of patients, and would not require approval from DHMA.


Regulations in the UK

In the UK, The Medicines and Health care products Regulatory Agency (MHRA) has provided guidance for the use of non-CE marked devices in clinical trials that do not have the purpose of supporting an application for CE-marking. See under the heading 'Clinical investigations and healthcare establishments', para 3:


"Generally, a healthcare establishment will not be treated as a manufacturer of a device for the purposes of the Regulations because it uses that device for a purpose not intended by the manufacturer. This is because the Regulations do not cover the user. Similarly, where a healthcare establishment uses a device for a purpose other than that stated by the manufacturer on a trial basis on their own patients, the MHRA would not treat that as a clinical investigation unless the intention of the healthcare establishment was to seek commercialisation of the device for the new intended use".


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