04 Aug EMA consults on medical devices in combination products_Deadline 31.Aug.2019
The European Medicines Agency (EMA) has released a draft guideline on the medical device quality requirements for drug–device combinations (medicines that include a medical device). The guideline (dated 29 May 2019) addresses the new obligations in Regulation (EU) 2017/745 on medical devices, in particular that a marketing authorisation application should include a CE certificate, a declaration of conformity for the device or, in certain cases, an opinion from a notified body on the conformity of the device. The guideline covers devices that are necessary for the administration, dosing or use of medicines that are:
- integral drug–device combinations, eg. dry powder inhalers and implants containing medicinal products whose primary purpose is to release the medicinal product
- non-integral drug–device combinations, eg. injection needles and refillable pens.
The guideline specifies which information about the device must be submitted in the initial marketing authorisation application and then throughout the product lifecycle.
The 3-month consultation ends on 31 August 2019, with a final guideline due before the regulation takes full effect on 26 May 2020.
Link to the guideline:
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