b. Rule 14 of the EU MDR This classification rule of the EU MDR applies to all devices incorporating, as an integral part, a substance which, if used separately, may be considered to be a medicinal product with the meaning of Directive 2001/83/EC, including medicinal product derived from human blood or human plasma. This special rule increases the classification of the relevant device to the highest risk of the EU MDR – Class III. Under the old Directives, not every inclusion of a medicinal product led to a Class III classification since the liability of the substance to act on the human body was considered during the classification decision process. For devices falling under this rule, the quality, safety and usefulness of the substance shall be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC. This process is unknown for a lot of affected manufacturers. Also, the adopted consultation process related to the activities of the notified body to seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA is unclear. AKRA TEAM can help you preparing the relevant regulatory strategy, selecting the right notified body, planning a pre-submission meeting with a designated competent authority, preparing compliant documentation and submitting your CTD File in accordance with the applicable requirements