Consultation procedure for medical devices

Medical devices may contain a substance that is an integral part of the medical device, but which would be a medicinal product when used separately. The organisations that assess medical devices, the so-called 'notified bodies', must - when assessing such medical devices - seek advice about the substance from a competent authority via a consultation procedure. The MEB can act as a competent authority.

The notified body takes the final decision about whether or not to approve (certify) the medical device and therefore has executive responsibility. The MEB issues scientific advice about the quality and safety of the substance, including the benefits/risks of the incorporation of the substance in the device.

The MEB's opinion on the substance in the medical device is binding under the Medical Device Regulation (MDR, EU 2017/745). In the event of a negative opinion, the notified body is not allowed to issue a certificate. Regulation EU 2020/561 entered into force on 24 April 2020. The implementation of the MDR has been postponed by one year as a consequence of COVID-19. The MDR will therefore come into effect on 26 May 2021 instead of on 26 May 2020.

The MEB has been consulted regularly by various notified bodies since 1995. The substances in question are assessed by employees who also assess the medicinal product dossiers in the pharmacotherapeutic groups.

As in the case of medicinal product assessment procedures, scientific or regulatory advice can be requested, or a pre-submission meeting convened, prior to a consultation procedure. The consultation procedure is subject to dossier requirements and assessment deadlines. The consultation procedure is concluded with an opinion.

After receipt of a positive opinion (and certification) for a medical device, a variation can be submitted, adverse reactions or calamities can be reported, or a reconsultation with a view to recertification under the MDR can be applied for at a later stage of the life cycle (if the medical device was initially certified under the MDD (Medical Device Directive).

In principle, the original medicines agency must be consulted for variations. However, for the sake of continuity it is preferable - including for reconsultations - to consult the original medicines agency.