The European Medicines Agency (EMA) has published a guidance document dedicated to the quality documentation for medicinal products when used with a medical device. The present document constitutes a final version which will enter into force on January 1, 2022.
The guidance outlines the scope of information to be provided for a medicine that is intended to be used with a medical device. In particular, the document addresses the core points related to the safety and performance of such products. In particular, the document covers products in which:
- The primary action is caused by a medicine, while the medical device could not be reused;
- Medicine is supplied together with a medical device (co-packaged products), provided they are placed on the market by the Marketing Authorization Holder (MAH);
- Medical devices to be used together with the product should be obtained separately, while the information accompanying the medicine contains references to the particular medical device to be used.
There are numerous medical products intended to be used with medical devices. Such products are different in terms of intended purpose and complexity and thus require a specific regulatory approach to be applied. The agency states that quite often, the information provided with medical products in terms of medical devices they should be used with is incomplete and lacks important details. The present guidance is intended to provide the responsible parties applying for marketing approval with regard to such devices and other parties involved with additional recommendations to be considered when preparing the information to be submitted. In particular, the document outlines the scope of information to be provided to a Competent Authority (CA) in each of the three aforementioned cases. The agency also mentions that the regulatory approach described herein complies with the provisions of the Medical Devices Regulation 2017/745 (MDR), which establishes a general regulatory framework for medical devices.
The agency emphasizes that the scope of information a responsible party shall submit to a CA in each particular case will actually depend on the design and construction of the product in question, as well as the risks associated thereto.
First, the guidance provides the definitions of the main terms and describes in detail the underlying concepts. For instance, according to the document, the term “device (part)” refers to a medical device, or parts of a medical device, that are used in an integral or co-packaged configuration. The guidance further describes each of the three aforementioned types of products, namely:
- Integral, which applies for products in which the medicinal product is principal. Such products should comply with the General Safety and Performance Requirements with regard to the device part. The scope of this term covers various products including the following:
- 1.Single-use pre-filled syringes that are not intended to be reused or refilled;
- 1.Drug-releasing intra-uterine devices and pre-assembled, non-reusable applicators for vaginal tablets;
- 2.Dry powder inhalers and pressurised metered dose inhalers that are preassembled with the medicinal product and ready for use;
- 3.Implants containing medicinal products whose primary purpose is to release the medicinal product.
2. Co-packaged, which refers to cases when medicine and a medical device are supplied together in a single pack;
3. Referenced, where the information accompanying medicine contains references to the particular medical device, while such device is not supplied together with medicine and thus should be obtained separately. The scope of information to be provided to the authority should depend on the risks associated with the use of such products, while a medical device itself should comply with any and all regulatory requirements set forth under the medical device framework.
According to the guidance, medical devices covered by points 2 and 3 include the following ones:
- Oral administration devices;
- Injection needles;
- Refillable/reusable pens and injectors;
- Refillable/reusable dry powder inhalers and metered dose inhalers, spacers for inhalation sprays;
- Nebulisers and vaporisers;
- Single use or reusable pumps for medicinal product delivery.
The scope of the present EMA guidance covers the regulatory matters related to the information an interested party shall submit to the regulating authority in the context of a marketing authorization application (MAA) or post-authorization applications. It applies to medical products in which the primary action is performed by a medicinal product contained therein. The EMA mentions that the approach described in the document could be applied for chemical, biological and radiopharmaceutical products. At the same time, the agency additionally emphasizes that recommendations provided herein should not be considered as exhaustive, and the applicable recommendations described in other relevant guidance documents should remain applicable. The scope of the guidance also covers the products intended to be used with low-risk (Class I) medical devices.
It is important to mention that the scope of the present document does not cover the following types of products:
- Veterinary products;
- In vitro diagnostic devices, including companion diagnostics;
- System and procedure packs regulated under Article 22 of the MDR;
- General groups of devices where reference is directly made, or inferred, in the product information, (e.g. “using a syringe” or “an infusion line”, etc…);
- Products falling under the first sub-paragraph of MDR Article 1(8).
Advanced Therapy Medicinal Products (ATMPs)
The agency states that in the case of medical devices included in advanced therapy medicinal products, an applicant should consider the recommendations and clarifications provided in the appropriate ATMP-specific guidelines. However, if such documents do not specify the particular way the information about these medical devices should be included in the submission, an applicant should refer to the general principles and recommendations provided herein.
For instance, recommendations provided in the present EMA guidance should be considered for:
- Medical devices that are co-packaged with ATMPs;
- Separately obtained devices which are referenced in the medicinal product’s product information because of their potential impact on the quality, safety and/or efficacy of the ATMP.
In the case of such products, any deviations from the general requirements for the content of the marketing authorization applications set forth by the applicable regulations should be duly justified by the responsible party. Moreover, a risk-based approach should also be applied.
In summary, the present EMA guidance highlights the most important aspects related to the information about medical devices intended to be used with medicinal products in terms of marketing authorization applications. The document describes the three main types of such products and outlines the scope of information to be provided to the authority in each particular case depending on the way the medical device is supplied (e.g., co-packaged or should be obtained separately) and on the risks associated thereto.
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