Dossier specifications for medical devices and in vitro diagnostic medical devices
ANNEX IISupplementary provisions
ANNEX II Dossier specifications for medical devices and in vitro diagnostic medical devices 1. The dossier referred to in Article 9(2) of this Regulation shall for medical devices include: (a) the clinical evaluation assessment report; (b) the manufacturer’s clinical evaluation documentation submitted to the notified body pursuant to Section 6.1, points (c) and (d), of Annex II to Regulation (EU) 2017/745; (c) the scientific opinion provided by the relevant expert panels in the framework of the clinical evaluation consultation procedure; (d) all up-to-date published and unpublished information, data, analyses and other evidence as well as study reports and clinical study protocols and analysis plans from clinical studies with the medical device for which the health technology developer was a sponsor and all available information on ongoing or discontinued clinical studies with the medical device for which the health technology developer is a sponsor or otherwise financially involved, and corresponding information about clinical studies by third parties if available, relevant to the assessment scope as set out in accordance with Article 8(6), including the clinical study reports and clinical study protocols if available to the health technology developer; (e) HTA reports on the health technology subject to a joint clinical assessment, where appropriate; (f) data from registries concerning the medical device and information on studies based on registries; (g) if a health technology has been subject to a joint scientific consultation, an explanation from the health technology developer on any deviation from the recommended evidence; (h) the characterisation of the medical condition to be treated, including the target patient population; (i) the characterisation of the medical device under assessment, including its instructions for use; (j) the research question elaborated in the submission dossier, reflecting the assessment scope as set out pursuant to Article 8(6); (k) the description of methods used by the health technology developer in the development of the content of the dossier; (l) the results of information retrieval; (m) the characteristics of included studies. 2. The dossier referred to in Article 9(2) and (3) of this Regulation shall for in vitro diagnostic medical devices include: (a) the performance evaluation report of the manufacturer; (b) the manufacturer’s performance evaluation documentation, referred to in Section 6.2 of Annex II to Regulation (EU) 2017/746; (c) the scientific opinion provided by the relevant expert panels in the framework of the performance evaluation consultation procedure; (d) the report of the Union reference laboratory.