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Revised EMA Q&A on Implementation of MDR & IVDR to Combination Products

Date
June 21, 2024
Category

EU Regulations

Description

In May 2024 the EMA published revision 4 of its Q&A on the implementation of the Medical Devices Regulation (MDR) and the In-vitro Diagnostic Devices (IVDR). This is an extensive revision that provided answers to questions about combination products that consist of both a medicine and a medical device.

The additions start by reiterating that in the EU the applicable regulatory framework for combination products is determined by the principal mode of action of the product.

  • If the principal action of the product is physical and the medicine is ancillary then the product is regulated as a medical device. However, the medicine component does require a scientific opinion as to its quality and safety from either the EMA or a national competent authority.
  • If the action of the medicine is principal, the integral drug device combination (iDDC) product is regulated as a medicine. In this case, the relevant general safety and performance requirements of the Annex I of the MDR apply to the device part of the iDDC.
  • If a medical device is co-packaged or referenced in the product information of a medicine the device must meet the requirements of the MDR and will need to be CE marked.

A new Q&A provides clarification as what constitutes an integral drug device combination (iDDC), with examples, and the applicable regulatory requirements.

The applicability and meaning of MDR Article 117, which amended Annex 1 of the human medicines Directive 2001/83/EC, is explained in detail. One important question that is answered relates to making changes to iDDCs and whether new or updated device conformity assessments are required, which depends on the type of change being made:

  • Addition or full replacement of the device part:

A new conformity assessment must be provided.

  • Change to the device or a device part:

It is the responsibility of the MAH to determine when a new or updated Notified Body opinion is needed in support of a change to the device or its intended use. Detailed guidance is provided in the Q&A.

  • Changes to the medicinal product may also require a new or updated conformity assessment of the device component and, again, detailed guidance is given.

Further guidance is provided on how to submit minor changes, such as changes to the:

  • device supplier,
  • device dimensions,
  • device composition,
  • sterilisation method for a device

There are also new or revised sections covering:

  • Medicinal products that include a medical device in the secondary packaging of the marketed medicinal product (co-packaged).
  • Medicinal products that include a medical device in the secondary packaging of the marketed medicinal product (co-packaged)
  • Consultation procedure for companion diagnostics

The revised Q&A can be found at https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf.