A guidance recently published by the Medical Device Coordination Group (MDCG) explains the process for transitioning CE certificates for devices containing an ancillary substance under the Medical Device Regulation (MDR).
Any medical device which incorporates an ancillary substance that can be considered a medicinal product must be subject to consultation with the relevant medicinal product authority, for example, the European Medicines Agency (EMA). The consultation would assess the clinical benefit-risk profile, quality and safety of the ancillary substance in the medical device. A supplementary consultation may also be required to review changes to the substance or its manufacturing process to ensure that the benefit-risk profile of the device is not impacted negatively.
The guidance explains the differences in requirements from previous legislation such as the Medical Device Directive (MDD). The process is similar under MDR, however changes include a 210-day timeframe for competent authorities to provide an opinion for initial consultations, and 60 days for supplementary consultations.
Under MDR, notified bodies must complete a full conformity assessment for the device, including the consultation of the medicinal products authority. While the guidance acknowledges there may have been no changes to the device or the ancillary substance since its last consultation, there may be changes in the documentation of the device due to the new requirements of the MDR, such as the clinical evaluation, or new information about the substance from the medicinal products authority. This may advertently affect the quality, safety or usefulness of the ancillary substance and influence a change in opinion. If the opinion is negative, the notified body must not issue a certificate under MDR.
The guidance notes that the medicinal products authority sought after by the notified body does not have to be the same as the one consulted under the previous legislation. For an initial consultation under the MDR, notified bodies must submit the full documentation package to the medicinal products authority. The documentation package should include the previous opinion for the ancillary substance and a consolidated list of changes. Notified bodies may also include a declaration stating whether there were changes made pertaining to the ancillary substance, the notified body’s assessment of the product or whether only administrative changes were made.
The guidance also explains differences in requirements and consultations for devices with ancillary substances manufactured using animal tissues under MDR.
Click here to access the guidance.