Draft EMA Guideline + MDCG Guidance to be endorsed

EMA (European Medicines Agency) has opened public consultations on the draft Guideline for drug-device combination products that will close on the 31st of August 2019.

Scope of the Guideline: medical devices and/or device components that are integral to the medicinal product or non-integral, i.e. co-packaged with the medicinal product or referenced in the medicinal product information and obtained separately [ Article 1(9) + Article 1(8) of the MDR as applicable].

The document provides guidance on the documentation expected for Drug-Device Combinations (DDCs) in the quality part of the dossier for a marketing authorisation application or a variation application. It is divided in two big sections and covers Integral DDCs and Non-Integral DDCs, but also touches on the topic of emerging technologies. Each section is subdivided in various models:

  • Module 1, Product Information
  • Module 3.2.P, Drug Product  [with several subsections]
  • Module 3.2.A.2, Adventitious Safety Evaluation
  • Module 3.2.R, Regional Information, Medical Device

On the approval process of DDCs: The core and general rule is that the Competent Authority for the regulation of medicines (CA) will evaluate the device specific aspects of safety and performance relevant to the quality, safety and efficacy of the medicinal product, and that, as applicable, the Notified Body will assess the relevant GSPRs (General Safety and Performance Requirements).

The next meeting of the MDCG is planned for 20 June 2019! The endorsement of the below Guidance under the new Regulation is expected:

  • Vigilance: Manufacturer Periodic Safety Report (MPSR) form
  • Implant card guidance
  • Guidance on Summary of safety and clinical performance
  • Person responsible for regulatory compliance, guidance on article 15 MDR / IVDR

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