Ancillary medicinal substances are medicinal products that are incorporated within a medical device, with the device being the primary driver of its mode of action. While we have previously discussed the requirements concerning combination devices in line with the EU MDR, this article will focus on the specific requirements associated with ancillary medicinal substances.
Complying with regulatory requirements for medical devices that incorporate medicinal substances can be quite challenging. The certification process for these types of products is often more demanding and time-consuming. It entails meeting rigorous standards to ensure the safety, efficacy, and quality of both the medical device and the incorporated medicinal substance.
One of the key aspects in obtaining certification for medical devices incorporating ancillary medicinal substances is demonstrating the compatibility and proper integration of the medicinal substance with the device. This involves thorough testing, documentation, and validation to establish the device’s intended mode of action and its effectiveness in combination with the medicinal substance.
Additionally, manufacturers must comply with stringent regulations related to the development, manufacturing, labeling, and marketing of such products. This includes adhering to Good Manufacturing Practices (GMP) for the production of medicinal substances and ensuring proper labeling and instructions for use.
Furthermore, post-market surveillance and vigilance requirements are heightened for medical devices incorporating medicinal substances. Close monitoring of adverse events, side effects, and product performance is necessary to ensure patient safety and to promptly address any issues that may arise.
It is important for manufacturers to engage in comprehensive risk assessment and management processes when developing and commercializing medical devices with ancillary medicinal substances. This involves identifying potential risks associated with the medicinal substance, evaluating its interactions with the device, and implementing appropriate mitigation strategies to minimize any adverse effects.
By navigating these regulatory challenges and fulfilling the necessary requirements, manufacturers can bring to market safe and effective medical devices that incorporate ancillary medicinal substances. This ensures that patients receive the intended therapeutic benefits while maintaining the highest standards of quality and safety.
General MDR Requirements for Ancillary Medicinal Substances
The requirements pertaining to medical devices that incorporate ancillary medicinal substances are primarily outlined in Annex IX, section 5.2b of the relevant regulations. Additionally, there is a specific MDCG (Medical Device Coordination Group) guideline titled “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 (Transmissible Spongiform Encephalopathies) susceptible animal tissues,” dated June 2020.
Let’s delve into the requirements stated within Annex IX, section 5.2. According to this section, if a medical device incorporates a substance that, if used separately, could be categorized as a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, including medicinal products derived from human blood or plasma, and if this substance has an action ancillary to that of the device, then the quality, safety, and effectiveness of the substance must be assessed using methods analogous to those specified in Annex I to Directive 2001/83/EC.
Essentially, this implies that the competent authority responsible for evaluating the substance’s quality and safety (such as the European Medicines Agency, EMA, within Europe) should assess it in accordance with the guidelines and standards outlined in Directive 2001/83/EC. This directive covers a range of requirements, including analytical, pharmacotoxicological, and clinical standards and protocols for testing medicinal products (as described in Annex I of the directive).
It is crucial for manufacturers of medical devices incorporating ancillary medicinal substances to comply with these requirements. They must ensure that the incorporated substances meet the necessary quality, safety, and usefulness standards as determined by the competent authorities. This typically involves providing comprehensive documentation, test results, and evidence of conformity with the applicable regulations.
Furthermore, manufacturers should consider the guidance provided in the MDCG guideline mentioned earlier. This document offers transitional provisions and recommendations for consulting with authorities on devices incorporating ancillary medicinal substances and devices manufactured using TSE susceptible animal tissues. Adhering to this guidance can help ensure compliance with the relevant regulations and facilitate a smooth regulatory approval process.
By understanding and fulfilling these requirements, manufacturers can navigate the regulatory landscape effectively, ensuring that their medical devices incorporating ancillary medicinal substances meet the necessary quality and safety standards, and ultimately provide valuable and safe healthcare solutions to patients.
Consultation with EMA
Within the Medical Device Regulation (MDR), there is an important requirement that addresses the assessment of EU technical documentation before issuing a certificate. This requirement states that the notified body, after verifying the usefulness of the substance as part of the device and considering the device’s intended purpose, must seek a scientific opinion from a competent authority designated by the Member States according to Directive 2001/83/EC or from the European Medicines Agency (EMA). This competent authority, referred to as the “medicinal products authority consulted,” provides an opinion on the quality, safety, and benefit or risk associated with the incorporation of the substance into the device.
From a practical standpoint, the MDR mandates that notified bodies consult a competent authority regarding the quality and safety of medicinal substances incorporated in medical devices. The notified body is required to consider the scientific opinion provided by the competent authority before making a final decision on certifying the device. In Europe, the competent authority for medical products is the European Medicines Agency (EMA).
When a notified body needs to seek consultation, it must notify the EMA of its intention to submit an application for initial consultation on an ancillary medicinal substance. This notification is done through a “letter of intent” sent at least six months before the expected submission date. This means that the approval process for medical devices incorporating ancillary substances can be lengthy due to the necessary consultation and evaluation procedures.
It is important for manufacturers and notified bodies to be aware of these requirements and timelines to ensure compliance with the MDR. The involvement of competent authorities and the EMA in assessing the quality and safety of medicinal substances integrated into medical devices adds an additional layer of scrutiny and ensures patient safety. By following the prescribed procedures and allowing for sufficient time for consultation, manufacturers can navigate the certification process smoothly and bring their medical devices incorporating ancillary substances to the market with confidence.
Subscribe to 4EasyReg Newsletter
4EasyReg is an online platform dedicated to Quality & Regulatory matters within the medical device industry. Have a look to all the services that we provide: we are very transparent in the pricing associated to these consulting services.
Within our WebShop, a wide range of procedures, templates, checklists are available, all of them focused on regulatory topics for medical device compliance to applicable regulations. Within the webshop, a dedicated section related to cybersecurity and compliance to ISO 27001 for medical device organizations is also present.
As one of the leading online platforms in the medical device sector, 4EasyReg offers extensive support for regulatory compliance. Our services cover a wide range of topics, from EU MDR & IVDR to ISO 13485, encompassing risk management, biocompatibility, usability, software verification and validation, and assistance in preparing technical documentation for MDR compliance.
Do not hesitate to subscribe to our Newsletter!
