Ancillary medicinal substances are defined as medicines that is incorporated within a medical device where the main mode of action is due to the device. We have already been taken in consideration the requirements related to combination devices according to EU MDR; in this article, we will deal more specifically with the requirements associated to ancillary medicinal substances.
Regulatory requirements for medical devices incorporating medicinal substances are challenging and the process to obtain certification for this type of products can be more demanding and time-consuming.
General MDR Requirements for Ancillary Medicinal Substances
The requirements related to this specific type of medical devices are defined mainly in Annex IX, section 5.2b; moreover, a specific MDCG guideline entitled “Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues June 2020“.
First of all, within Annex IX, section 5.2, the following requirements are stated:
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma and that has an action ancillary to that of the device, the quality, safety and usefulness of the substance shall be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.
This basically means that, in relation to the specific substance(s) contained in the device, quality and safety of this substances shall be evaluated by the related competent authority (such as EMA, for Europe) according to Directive 2001/83/EC (Annex I: Analytical, Pharmacotoxicological and Clinical Standards and Protocols in respect of the testing of Medicinal Products).
Consultation with EMA
Within the MDR, it is also mentioned the following requirement:
“Before issuing an EU technical documentation assessment certificate, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred to in this Section as ‘the medicinal products authority consulted’ depending on which has been consulted under this point, on the quality and safety of the substance including the benefit or risk of the incorporation of the substance into the device”.
From practical point of view, the MDR requires notified bodies to seek an opinion from a competent authority on quality and safety of a medicinal substances incorporated in a medical device. The notified is obliged to take in consideration the scientific opinion of the competent authority before taking a final decision on the certification of the device in question. In relation to the medical products, the competent authority in Europe is the European Medicines Agency (EMA).
The notified body that needs a consultation shall notify the EMA of the intention to submit an application for an initial consultation on an ancillary medicinal substance by sending “a letter of intent” at least 6 months before the expected date of submission. This basically means that the timing for the approval of medical devices with ancillary substances might be quite long.
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- Source: https://www.qualitymeddev.com/2022/08/23/ancillary-medicinal-substances/
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