Substance-Based Devices Welcome to your Substance-Based Devices First and Last Name Email Organisation 1. Why it was necessary to introduce new requirements in MDR for substance-based medical devices? To ensure that substance-based devices undergo rigorous testing and evaluation to confirm their safety. The strengthened the rules under MDD applied to invasive devices that do not sufficiently take account of the level of invasiveness and potential toxicity of certain devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body To increase the risk classification in class III of the device composed of substances or of combinations of substances None 2. What is the regulatory importance of substances-based devices? The highest risk classification under MDR Clear demarcation to distinguish between substance-based medical devices and medicinal products/cosmetics, ensuring they are regulated by the appropriate framework The involvement of NB in the conformity assessment for all substances-based product None 3. For which substances-based device absorption, distribution, metabolism and excretion (ADME) are to be investigated? Vaginal ovules for the treatment and prevention of alterations of the vaginal mucosa Topical cream for acne treatment All the above None 4. Which is an example of substance-based device that fall under the MDR rule 21? Syrups Syringes prefilled with medicinal product Polyurethane film containing polyhexamethylene biguanide (PHMB) None 5. Which is an example of substance-based device that fall under the MDR rule 4? Viscoelastic dermal fillers Topical cream indicated for the treatment and care of damaged skin such as second-degree burns, ulcers, radiodermatitis. Gel indicated to treat the symptoms of teething in infants, especially to decrease the pain sensation None 6. Which are the main aspects NB has to assessed according to MDR requirement for substance-based devices? Detailed information on the chemical and biological composition of the substances used Toxicological and chemical characterization Qualification and dynamic aspects, classification, quality and safety, biocompatibility including kinetic aspects. None 7. Is it possible to cumulatively apply the provisions of the Medicinal Products Directive (MPD) and Medical Device Regulation (MDR)? yes No None 8. Can a medical device have a key-lock mechanism of action? Yes No None 9. Are the disinfectants, used on non-intact skin or on the patient prior to surgery, medical devices? Yes No None 10. Are the dental filling materials, medical devices? Yes No None 11. If it is demonstrated by the manufacturer that a substance with plant origin achieves its principal intended action by means other than pharmacological, immunological or metabolic, it is possible qualified te respective product as a medical device? Yes No None 12. What is the concept of “Intentionality”? The intention of the manufacturer that medical device is safe. The intention of the manufacturer regarding the action of the substance on the device or on the body is irrelevant for the decision on whether the substance would be considered a medicinal product. The intention of the manufacturer that an herbal medical device is natural. None 13. A consultation with an EU Medicines Agency is required for which type of Rule 21 device All Rule 21 Devices All Class III, Rule 21 Devices Class III, Rule 21 Devices, if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose. None 14. Manufacturers of Rule 21 devices need to consider what particular aspects for compliance with GSPR 12.2 Potential for adverse reactions Interactions with other devices, medicinal products or other substances Local tolerance and toxicity All of the above None 15. GSPR 23.3 (r) required that he Information on the label contains Quantitative Information on all ingredients in the device Qualitative information on the constituent (s) responsible for achieving the principal intended action The overall qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action None 16. GSPR 23.4 (t) requires that the IFU contains The overall qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action Information on the local toxicity Information on the risk of re-use Contraindications, undesirable side-effects and risks relating to overdose None 17. If MDR Rule 21 applies to a device, then Rule 14 cannot be applicable True False None 18. What types of data are appropriate to demonstrate ADME aspects for Rule 21 devices Biocompatibility data, generated in accordance with ISO 10993 Extensive Pharmacokinetic (PK) AND Pharmacodynamic (PD) Studies Published literature / information on the main constituent or constituents responsible for achieving the principal intended action A combination of a and c None Time's up pascaleperspectives2025-04-17T10:45:07+02:00
