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Additional Information

Accreditation process for research centres:
The Italian Ministry of Health issued a decree on the suitability of investigation sites conducting clinical studies on medical devices, aiming at strengthening the overall safety of patients in Italy. The Ministerial Decree 12 March 2013 upgrades and puts order in the list of Italian sites where clinical investigations involving medical devices not bearing the CE mark can be performed, introducing further types of settings, not previously contemplated under the law.

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