European Commission considers single submissions for multi-site investigations
March 31 2011
The details of how the commission is envisaging managing multi-site clinical investigation applications for medical devices under the recast medical device directives are set out in a so-called "non-paper" from the commission that Regulatory Affairs Medtech sister publication Clinica Medtech Intelligence has obtained.
At Present, companies wanting to carry out multi-centre clinical investigations for medical devices need to apply for approval with competent authorities and ethics committees in each and every member state where they plan to conduct these investigations.
The commission's new proposals entail:
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a single entry point - and single submission - for application from sponsors for multi-site clinical investigations;
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facilitation of the designation of the lead natinal competent authority;
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co-ordination of the technical assessment (according to commission MEDDEV guidance) by the individual competent authorities);
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establishing a platform for (voluntary) exchanges of views between ethics committees ; and
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setting up and managing a European data-processing network for reporting serious adverse events and co-ordinating their analysis as well as responses to them in the case os serious safety concerns.