Article 15Commission’s confirmation of the dossier for a joint clinical assessment#
Within 15 working days from the date on which the health technology developer submitted the dossier, and as appropriate in consultation with the assessor and co-assessor, the Commission shall confirm whether, based on the information available at the time, the dossier for a joint clinical assessment of the medical device meets the requirements laid down in Article 9(2), (3) and (4) of Regulation (EU) 2021/2282.
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