Unit MEDICAL DEVICES
- Course
- Industrial pharmacy
- Study-unit Code
- A003606
- Curriculum
- In all curricula
- Teacher
- Matteo Puccetti
- Teachers
-
- Matteo Puccetti
- Hours
- 32 ore - Matteo Puccetti
- CFU
- 4
- Course Regulation
- Coorte 2024
- Offered
- 2025/26
- Learning activities
- Affine/integrativa
- Area
- Attività formative affini o integrative
- Academic discipline
- CHIM/09
- Type of study-unit
- Opzionale (Optional)
- Type of learning activities
- Attività formativa monodisciplinare
- Language of instruction
- English
- Contents
- 1. Legislation and classification of medical devices; 2. Regulatory bodies and the role of notified bodies; 3. Nomenclature, traceability and spending limit of the National Health Service for MDs; 4. Clinical Trials of MD and Surveillance Devices; 5. Substance-based DM and Borderline DM, safety and compliance; 6. Biocompatibility materials and sterilization; 7. Materials used in medical devices. 8. Devices for specialist surgery, clinical medicine and diagnostics. 9. Consultation of official sources; 10. Career opportunities in the medical devices sector.
- Reference texts
- Official legislation: EU Regulation 2017/745 https://eur-lex.europa.eu/legal-content/IT/ALL/?uri=celex:32017R0745 Ministerial documents (https://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=1346&area=dispositivi-medici) EUDAMED https://europa.eu/eudamed; IMDRF (International Medical Device Regulators Forum) http://www.imdrf.org In Italian: -MEDICAL DEVICES AND APPLICATION IN HOSPITAL PHARMACIES: VADEMECUM” SiFO. (https://www.sifoweb.it/images/pdf/pubblicazioni/altre-edizioni/SIFO_VADEMECUM_versione_definitiva.pdf, Free PDF); -Medical Devices - Regulatory and operational aspects - Ministry of Health (https://www.salute.gov.it/imgs/C_17_pubblicazioni_1238_allegato.pdf, free PDF) In lingua inglese: "Medical Device Guidelines and Regulations Handbook" Springer (2022) DOI: 10.1007/978-3-030-91855-2
- Educational objectives
- The course aims to provide in-depth and transversal knowledge on medical devices (MD), with particular attention to regulatory, technological, clinical and industrial aspects. The student will learn: -Importance of DM and IVR for Human Health; - The regulatory classification of medical devices according to MDR 2017/745. - The technological and material principles used in the design of devices. - The bases of clinical evaluation, HTA and hospital purchasing process. - The operational skills to understand official sources and the labor market in the DM sector
- Teaching methods
- The course is organized as follows: Face-to-face lectures on all the topics of the course
- Learning verification modality
- The evaluation test is unique and has the objective of ascertaining the effective acquisition by the student of the knowledge concerning the frontal lessons and takes place with an oral exam. The oral test consists of a discussion lasting about 30-45 minutes aimed at ascertaining the level of knowledge and understanding achieved by the student on the theoretical contents indicated in the program. The oral test will also allow to verify the student's communication skills with property (adequacy) of language and autonomous organization of the exposition on the same theoretical topics. The oral test also allows to ascertain the student's ability to connect the topics to each other when it is relevant. For information on support services for students with disabilities and/or DSA, visit the page http://www.unipg.it/disabilita-e-dsa
- Extended program
- 1 Legislation and Classification of Medical Devices Overview of the European MDR 2017/745 regulation. Definition of a medical device. Risk-based classification (I, IIa, IIb, III). Distinction between devices, drugs,cosmetics. Introduction to implantable and diagnostic devices. 2 Regulatory bodies and the role of notified bodies Role of the Ministry of Health as the Competent Authority. Functions of Notified Bodies. CE marking certification process. Accreditation, surveillance, and document verification. 3 Nomenclature, Traceability, and Spending Cap for Medical Devices Use of CND, GMDN, and UDI codes for classification and traceability. Introduction to the EUDAMED database. Definition of the NHS spending cap and implications for suppliers. 4 Clinical Trials of MD and Surveillance Devices Requirements for conducting clinical investigations under ISO 14155. Key documents (CIP, IB, CRF). Role of Ethics Committees. Post-market surveillance system, incident reporting, and corrective actions. 5 Substance-based DM and Borderline DM, safety and compliance Definition of substance-based devices. Management of borderline products. REACH, CLP, and RoHS requirements. Labeling and chemical safety obligations. 6 Biocompatibility, materials and sterilization Biocompatibility assessment according to ISO 10993. Main biological tests. Sterilization techniques: EtO, gamma, steam. Process validation and residue control. 7 Materials Used in Medical Devices Metallic, polymeric, ceramic, and bioabsorbable materials. Material selection based on clinical use. Impact on sterilization and device durability. 8 Devices for Specialized Surgery, Clinical Medicine, and Diagnostics Examples of devices used in orthopedic, cardiovascular, neurosurgical, intensive care, and diagnostic procedures. IVD classification and regulatory requirements. 9 Consultation of Official Sources Guide to researching official regulations, guidelines, and databases (Ministry of Health, EUDAMED, FDA, EMA), with practical examples of use. 10 Career Opportunities in the Medical Device Sector Overview of key professional roles: R&D, regulatory affairs, quality, production, marketing. Required skills and post-graduate paths.
- Obiettivi Agenda 2030 per lo sviluppo sostenibile
- Health, wellness and wellbeing