Updated Clinical Evaluation Guidance on Comparability

In an effort to bring its guidance documents on clinical evaluation up to date, the International Medical Device Regulators Forum (IMDRF) has asked for feedback on proposed revisions to three documents, including how to demonstrate equivalence to comparable devices. 

The proposed revisions for public consultation are indicated in each of the relevant guidance documents – the documents are freely available (please let us know, should you require a copy):

  1. Clinical Evaluation (previously GHTF/SG5/N2R8:2007)
  2. Clinical Evidence-key definitions and concepts (previously GHTF/SG5/N1R8:2007)
  3. Clinical investigations (previously GHTF/SG5/N3:2010)

A crucial factor when developing a new medical device is whether a clinical trial is obligatory or if clinical evidence may be (partially) based on data from equivalent devices. The forum explains that a set of globally harmonized standards might cut out the necessity of having to carry out additional regional clinical trials and encourage the introduction of devices in multiple jurisdictions.

The IMDRF believes that the existing SG5/N2R8 guidance on clinical evaluation is inadequate in helping manufacturers who are trying to demonstrate equivalence of their new device to a comparable device. Additionally, since this was issued in 2007, several jurisdictions have updated and put into effect their obligations on equivalence demonstration, such as the acceptance level of differences etc.

Readers are generally encouraged to review the proposed documents – they may give further clarity about expectations under Regulation (EU) 2017/745 on medical devices (MDR) because they are enhancements of the former GHTF documents on which MEDDEV 2.7/1, rev. 4 was based.

Sources: Medtech Insight (an Informa product), bsi

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