I do not personally have experience with getting combination devices approved in the EU, but I did some research on this topic and I found an interesting article explaining that the EMA is considering developing a new guideline on quality requirements for combination products. In the EU, CE marked medical devices are provided separately but may be co-packaged with the medicinal product, and the assessment performed by the notified body may not fully take into account the characteristics of the specific medicinal product that the device is to be used with. The proposed guidelines would show that the combination has been appropriately designed and controlled and can be used correctly in the intended clinical situations.

https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/2/ema-weighs-new-guideline-on-quality-requirements-for-combination-products