EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2014

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26 | Spring 2014 European Medical Device Technology emdt.co.uk regulations and standards Clinical Investigation Study Design Chapter II of Annex XIV, Documenta- tion regarding the application for clinical investigation, contains a comprehen- sive list of information that needs to be included in a clinical investigation appli- cation. For example, subparagraph 1.11 states that a summary of the Clinical Investigation Plan (CIP) must be included that describes, among other elements, the design of the investigation, such as a controlled and/or randomised study. EP amendment 340 adds the follow- ing to the Commission proposal text: "As randomised controlled investigations usu- ally generate a higher level of evidence for clinical efficacy and safety, the use of any other design or study has to be justified. Also, the choice of the control interven- tion shall be justified. Both justifications shall be provided by independent experts with the necessary qualifications and expertise." The EP appears not to have considered that, in many cases, a randomised con- trolled study design may not be feasible or ethical when studying a medical device. Such a study design should be considered an option with clear potential advantages. But a requirement limiting medical device clinical investigations to this design further underscores the apparent lack of medical device expertise within the EP. Postmarket Clinical Follow-Up (PMCF) The proposed regulations also clarify and strengthen requirements for PMCF. For example, paragraph 6 of Article 8, General obligations of the manufacturer, specifies that manufacturers must develop a post- market surveillance plan, which must set out the process for collecting, recording and investigating complaints and reports from healthcare professionals, patients or users on suspected incidents related to a device, in addition to meeting other requirements. The Article further stipulates that the postmarket surveillance plan must include a plan for PMCF in accordance with Part B of Annex XIII. EP amendment 330 would require manufacturers to make all clinical data collected as part of a PMCF accessible to health professionals. Amendment 331 would require PMCF studies to be regis- tered in the electronic system on vigilance referred to in Article 62 of the proposed regulation. EP amendment 332 would require that the PMCF evaluation report, as discussed in paragraph 3 of Part B of Annex XIII, is sent periodically to the concerned Member States. In addition, it would require that, for all Class III devices, a third party or exter- nal expert review the same report under the principles of highest scientific competence and impartiality. This proposed amend- ment will need to be carefully evaluated to determine whether its benefits justify the additional associated time and costs. ES430750_EMDT1405_026.pgs 04.29.2014 03:27 UBM black yellow magenta cyan

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