Many healthcare products are sold as a combination of a medicine with a medical device. Examples include drug-eluting cardiac stents and pre-filled injector pens. Products like these offer safety and convenience benefits for the clinician and the patient, but they often involve additional regulatory hurdles for producers. Because medicines and medical devices are regulated separately under different laws and through separate bodies and procedures, it can be difficult for manufacturers to understand how to navigate the path to market efficiently.
EU law reforms on the regulation of medical devices are due to take effect in May 2020. Among the changes is a new requirement for Notified Body involvement where a combination products falls within the regulatory system for medicines. Applicants for marketing authorisation will have to include details of the conformity assessment carried out in relation to the device element when preparing a marketing authorisation dossier for the combination product. More information on this can be found in a Q&A document issued jointly by the EMA and CMDh, available here.
In order to help applicants understand the new system, the EMA is currently consulting on detailed guidance for producers of drug-device combinations. These are intended to assist those filing a marketing authorisation application once the new medical devices regime takes effect.
Products classed as “drug-device combinations” include:
- devices which are integral to the medicinal product (pre-filled syringes, pens and injectors, drug-releasing intrauterine devices and dry powder inhalers, etc).
- non-integral devices, where a specific device is co-packaged with the medicinal product or referred to in the product information (oral administration devices, injection needles, pumps, nebulisers, etc).
The draft guidelines envisage the inclusion within the marketing authorisation dossier for an integral DDC of evidence that the device element of the combination meets the relevant safety and performance requirements (GSPRs). Depending on the type of device, this may be the manufacturer’s declaration of conformity, or a certificate issued by a notified body. Where these are not available, the applicant will need to provide other evidence that the device element meets the GSPRs.
The guidance explains
“The core precept of this guideline 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 NB will assess the relevant GSPRs.”
Note that Advanced Therapy Medicinal Products involving genes, cells or tissues are not covered. A separate set of rules cover ATMPs and these include situations where a device forms part of the active substance or formulation of an ATMP.
The consultation remains open until 31 August 2019.
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