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  • Feature ArticlesFeature Articles

    IVDR, notified bodies, and technical documentation: The devil is in the detail

    This article discusses notified body expectations for the technical file and provides some practical tips for preparing submissions.   Introduction The “devil is in the detail” is a phrase I’m using a lot these days, and it is a feature of the In Vitro Diagnostic Device Regulation (EU IVDR) 2017/746 1 that is tripping up IVD manufacturers as they make their first submissions.   The IVDR states in Annex II that:   The technical documentation and, if applicable...
  • Feature ArticlesFeature Articles

    The Essential IVDR and the Challenges it Presents

    This article discusses key elements of the In Vitro Diagnostic Regulation (IVDR) and the challenges it presents to manufacturers. The author covers device classification changes, oversight, clinical evidence and performance evaluation, and postmarket vigilance. She cautions about the effects of notified body reductions and the consequences. She concludes by warning that significant changes may impede market launch for some products.   Introduction   It is essential...