Revisited guideline for making a clinical investigation application under the Medical Device Directive (Meddev 2.7/2, revision 2)

(September 2015)

This updated guideline Meddev 2.7/2 revision 2, includes nine new appendices to support the validation and assessment processes of clinical investigations. The updated guideline states that clinical investigations should generally be 'designed, conducted and reported' either in accordance with the EN ISO 14155 (Good Clinical Practice requirements for medical device clinical trials) or to comparable standards, and in compliance with the Declaration of Helsinki and other national regulations.

The updated guideline:

  • Contains several new terms for which clear definitions have been provided. Some of these definitions will be adjusted later on when the Commission finalizes changes to its existing guidance Meddev  2.7.1.
  • Outlines procedures/documents/information that are of primary, but not exclusive importance for validation and decision-making with regard to ethical considerations of a device trial.
  • Describes considerations on which validation process (i.e. the administrative review) should be based. During the validation process the guideline states that national competent authorities should assure, among other things, that the investigational product qualifies as a medical device, and that the sponsor provides a rationale for the given classification of the device. In addition, the outlining the basic information that manufacturers should submit in their validation application, the guideline also lists 'additional documentation/information that competent authorities usually required to comply with national regulations'.
  • Outlines the steps to be followed for the assessment of clinical investigation applications to ensure that the essential requirements applicable to the investigational medical device, apart from those which are to be examined in the clinical investigation, are correctly identified and fulfilled (i.e. use of relevant harmonized standards).
  • Explains the types decisions that a national competent authority might issue based on the outcome of the validation and/or assessment process. In cases where an objection letter is issued, the guideline states that it should contain specific information required of the manufacturer in a resubmission in order to address the grounds for objection.
  • Describes the types of actions that national competent authorities can take while a clinical investigation is ongoing and the types of action that sponsors shuld take when they terminate or temporary halt a trial.

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