While at the EU level the discussion on the proposed regulations governing medical devices and IVD (both including provisions pertaining to clinical investigations involving devices) is ongoing and becomes more vibrant,1 on 12 March 2013 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.
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The Ministerial Decree of 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. Moreover, with this Decree the Italian Ministry of Health sets forth the requirements which such settings will have to meet in order to conduct the above mentioned studies, in accordance with Article 14 of Italian Legislative Decree n. 46/1997 (implementing EU Directive n. 93/42) subsequently amended by means of Italian Legislative Decree n. 37/2010 (implementing EU Directive n. 2007/47).
More precisely, the Ministerial Decree provides that the settings allowed to perform clinical investigations on non CE marked low risk medical devices (i.e. devices falling within class I, IIa and IIb excluding implantable and long-term invasive devices) shall be exclusively those utilizing in their ordinary clinical practice medical devices of the same category and class as the devices to be investigated. Furthermore, according to the Ministerial Decree, in these settings the clinical studies on medical devices shall be carried out only by qualified personnel with solid and documented experience in clinical trials activity. The necessary experience may be proved by scientific publications, patents or other equivalent means.
The above mentioned requirements shall be met also by settings performing clinical investigations on not CE marked high risks medical devices (i.e. devices falling within class III and implantable and long-term invasive medical devices falling within class II a or II b). In addition, the sites mentioned by the Ministerial Decree under Article 2, paragraph 1, letters g, h, i, l, m (e.g. publicly acknowledged institutions, research centers), shall also prove to have an operating unit staffed with personnel highly specialized in the medical area in which the investigational study is to be conducted (as required by Ministerial Decree 29 January 1992 or, alternatively, by Ministerial Decree 31 January 1995).
Last but not least, compliance with all the requirements established by the Ministerial Decree shall be proved by the manufacturers or their representatives within the EU by means of appropriate documentation to be submitted simultaneously with the notification of the clinical investigation at the Ministry of Health, pursuant to Article 14 of Legislative Decree n. 46/1997.
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The Ministerial Decree of 12 March 2013 appears to be fairly consistent with the objective of strengthening patients and customers’ safety, pursued by the EU legislator. At the same time, even in the event the proposed EU regulations mentioned above shall come into force (particularly in cases of multi-site, multinational centralized procedure), the Ministerial Decree would remain valid and positively regulate an important domestic aspect of the new procedure.
1 The ENVI Committee, which should vote on both regulations and their amendments on 10 July 2013, has just rescheduled its vote on 18 September 2013. That means that the plenary vote on the regulations, originally to take place in September, will move to November 2013.