Recertification of drug-device combination products
Check the risk class!
To avoid unnecessary delays in recertification, it is urgently recommended that you check the classification of your drug-device combination product before you submit additional documents. If your product is already classified as a class III Medical Device under rule 13, please check whether a positive opinion of a designated European competent authority is already available. In case of doubt please contact Dr. Bassil Akra, Head of Clinical Affairs at TÜV SÜD Product Service GmbH, to clarify this question.
Opinion of a competent authority necessary
According to MEDDEV 2.1/3, rev. 3, for Medical Devices incorporating medicinal substances as integral parts, the Notified Body, having verified the usefulness of the medicinal substance as part of the Medical Device and taking into account its intended purpose, must seek a scientific opinion from one of the competent authorities designated by the EU Member States or the European Medicines Agency (EMA), acting particularly through its committee in accordance with regulation EC No. 726/2004 on the quality and safety of the substance, including the clinical benefits/risk profile of the combination product.