Medical devices that incorporate ancillary medicinal substances are subject to rigorous regulatory compliance. Before issuing a CE certificate, the notified body shall seek a scientific opinion from one of the EU national competent authorities or from the EMA on the quality and safety of the substance including the benefit or risk of the incorporation of the substance into the device. A crucial aspect is the thoroughness of the documentation submitted during this process.
It was anticipated that comprehensive requirements will be provided in the MDCG 2022-5 that was published as guidance on borderline devices under the MDR and was intended to essentially replace the borderline guidance MEDDEV 2.1/3 Rev3, originally written for the MDD. However, focusing on differences between the MDD and MDR, MDCG 2022-5 doesn’t address the raised questions, just referring to the upcoming MDCG guidance that is not currently under development. Until then, MEDDEV 2.1/3 Rev 3 remains a reliable resource for manufacturers on the preparation to this consultancy procedure.
For devices that have already undergone consultation under the MDD, EMA/37991/2019 Q&A (Rev.2) and MDCG 2020-12 become also applicable specifying the list of documents that should be submitted additionally.
In conclusion, the regulatory landscape for medical devices with ancillary medicinal substances is intricate, requiring meticulous documentation and adherence to specific guidelines. Manufacturers must navigate this process diligently to ensure the successful results of consultation procedure. Please reach out to find out how we can help.