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EMA has opened a three-month consultation on its draft guidelines on the quality of requirements for drug-device combination products.
The European Medicines Agency (EMA) has opened a three-month consultation on its draft guidelines on the quality of requirements for drug-device combination products, it was announced in a June 4, 2019 press statement.
Covering devices that are necessary for the administration, dosing, or use of medicine, the guidelines address new obligations that fall under the European Union regulation 2017/745, particularly requirements listed under Article 117. The article indicates that there should be a Conformité Européenne (CE) certificate, or some other declaration of conformity of the device, or an opinion from a notified body (NB) on the conformity, included within the marketing authorization application.
The guidelines specify the device information that is required to be submitted as a part of the initial marketing authorization application, as well as the information required during the product lifecycle. Additionally, there is a proposed template included in the guidelines for the NB opinion on the device conformity to EU regulations.
It is anticipated that these guidelines will improve transparency and consistency of information provided in regulatory submissions, which will ultimately reduce the workload for all stakeholders and improve patient safety. All stakeholders will have an opportunity to send comments on the proposed guidelines until Aug. 31, 2019 to QWP@ema.europa.eu using the template provided by EMA, which is provided as a downloadable form in the draft guidelines.
Once all comments have been received and taken into account, EMA expects to finalize the guideline prior to the full application of the EU regulation on May 26, 2019.