In the dynamic world of pharmaceuticals, understanding the interplay between medicines and medical devices is crucial. Here's a breakdown of the essential types of products involving medicines and medical devices and their regulatory pathways.
- Combination Products Explained:
Drug-Device Combinations (DDCs) blend drug components with medical devices. They are regulated under either pharmaceutical or medical device frameworks, depending on their primary mode of action. Let's dive into the details:
a) Non-separable combinations
Integral Drug-Device Combinations (iDDC)
These are Medical Devices that form an integral product with a medicine. The medicinal product component is manufactured together with the medical device component as a combined unit intended exclusively for use in this specific combination. Medicinal product and device form a single integrated product, resulting in physical non-separability. There are two main types authorized under the medicine’s framework:
1. Medicinal product that includes a medical device
When these products are placed on the market or put into service, they incorporate, as an integral part, a substance that, if used separately, would be considered a medicinal product. This is provided that the action of the substance is principal and not ancillary to the action of the medical device (Article 1(8) MDR).
2. Single-Use Devices for Administering Medicinal Products
Devices intended to administer a medicinal product, where they form a single integral product intended exclusively for use in the given combination and which is not reusable (Article 1(9) MDR). Typically, these devices have measuring, metering or delivery functions.
The iDDC is governed under the medicinal products framework (Directive 2001/83/EC or Regulation (EC) No 726/2004) and the relevant general safety and performance requirements of the Annex I of the MDR apply to the device part of the iDDC (Article 1(8) of MDR).
Applications for a Marketing Authorisation of an iDDC submitted as of 26 May 2021 must comply with the requirements of Annex I to Directive 2001/83/EC, point 12 of section 3.2, as amended by Article 117 of Regulation (EU) 2017/745.
Article 117 of Regulation (EU) 2017/745 sets out that the DDC marketing authorisation dossier must include, where available, the results of the assessment of conformity for the device part (i.e. the declaration of conformity or the relevant EU certificate issued by a notified body). This requirement does not apply to Class I devices (non-sterile, non-measuring).
Examples of iDDCs: single-use pre-filled syringes, pre-filled inhalers, drug-releasing intra-uterine devices, patches for transdermal drug delivery.
Non-integral Drug-Device Combinations (Co-packaged)
They are combination products with use-specific non-separability. These combinations include separate items packed together, like a bottle of cough syrup and a measuring cup or a vial containing a medicinal product solution with an empty sterile syringe. The device is governed by the medical device framework and must be CE marked.
b) Separable combinations
Referenced (obtained separately)
These occur when the medicinal product information (SmPC and Package Leaflet) refers to a specific device to be used with the medicine, but the device is obtained separately. This happens when the medical device used may potentially impact the quality, safety and/or efficacy (and hence overall benefit/risk determination) of the medicinal product.
The device is governed by the Medical Device framework and should be CE marked.
2. Medical devices with an ancillary medicinal substance:
These medical devices contain an ancillary medicinal substance to support their proper functioning. The main mode of action is due to the device, not the medicinal substance. These products fall under the Medical Devices legislation and must be CE marked.
A scientific opinion on the quality and safety of the ancillary substance, including the benefit or risk of its incorporation in the device, must be provided from a national competent authorithy for medicinal products or from the EMA before a notified body can issue a EU certificate (Article 1(8) of MDR).
Examples: bone cement with antibiotics, heparin-coated catheters, condoms coated with spermicides.
3. Companion diagnostics (“in vitro diagnostics”):
A companion diagnostic is an in vitro diagnostic test essential for the safe and effective use of a specific medicinal product. It identifies patients who are suitable or unsuitable for treatment with a particular medicinal product.
Regulation (EU) 2017/746 mandates that companion diagnostics undergo conformity assessment by a notified body and a consultation with a medicinal products authority regarding the suitability of the device in relation to the medicinal product concerned. The Regulation applies from 26 May 2022, following a five-year transition period.
MDR: Regulation (EU) 2017/745 on medical devices.
Understanding these distinctions is crucial for compliance and safety in product development. If you need regulatory services for your medicine and Medical Device products, we're here to help!
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