Consultation on draft guideline on quality requirements for medical devices in combination products

June 3, 2019 – EMA has released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month public consultation. The guideline addresses the new obligations in Regulation (EU) 2017/745 on medical devices, in particular the requirements under Article 117. This article foresees that the marketing authorisation application should include a CE (Conformité Européenne … (leggi tutto)