Drug Device Combinations: Consultation on draft guideline on quality requirements

draft guideline ema

Drug Device Combinations: Consultation on draft guideline on quality requirements

On 03.06.2019 the European Medicines Agency (EMA) released a draft guideline on the quality requirements for medical devices (MD) in human medicines that include a MD (known as drug device combinations or DDC) for a 3-month public consultation, as part of a series related to the European’s medical devices regulation (MDR). The draft guideline covers devices that are necessary for the administration, dosing or use of the medicine. They can be devices that are integral to the medicinal product (integral DDC), or co-packaged with the medicinal product or referenced in the medicinal product information but obtained separately (non-integral DDC). It specifies which information about the device needs to be submitted as part of the initial marketing authorisation application (MAA) and subsequently during the product lifecycle.

A new template for the notified body (NB) opinion on the conformity of a device to the relevant general safety and performance requirements (GSPRs) laid down in MDR is proposed in the draft guideline.

The regulators will consider comments received during the public consultation (until 31 August 2019) with the goal to finalising the guideline before the regulation fully applies on 26 May 2020.

Please feel free to contact us if you need some help: [email protected].

Our Medical Devices’ team can support you!

Are you ready to enter the transformed landscape in Pharmacovigilance?
#SaveTheDate: 10th of October

Este sitio web utiliza cookies para que usted tenga la mejor experiencia de usuario. Si continúa navegando está dando su consentimiento para la aceptación de las mencionadas cookies y la aceptación de nuestra política de cookies, pinche el enlace para mayor información.

Aviso de cookies