Curricular Unit:			Code:
Medical Devices			1069DMED
Year:	Level:	Course:	Credits:
1	Postgraduate	Regulatory Affairs of Medication and Health Products	1 ects
Learning Period:		Language of Instruction:	Total Hours:
		Portuguese/English	13
Learning Outcomes of the Curricular Unit:
In module 3 - Medical Devices - of the Postgraduate Degree in Regulatory Affairs of Medicines and Health Products, the skills to be acquired include: knowing the medical devices circuit; knowing and being able to interpret the documentation supporting the introduction of medical devices into the market and knowing the circuit and the methodology for evaluating medical devices.
Syllabus:
1 - Concept of Medical Device (MD) and its regulatory definition; Classification of MD and borders with other legislations; The Notified Body and the Competent Authority; Post-marketing Surveillance System. 2 - Impact of essential requirements and various harmonized standards on Quality Systems Harmonized Standards applied to the manufacture and marketing of MD. Transition to the New Medical Devices Regulation (MDR). CER (Clinical Evaluation Report). 3 - Quality Management System. Risk Management System. Good Manufacturing Practice. Good Distribution Practices.
Demonstration of the Syllabus Coherence with the Curricular Unit's Objectives:
The postgraduate course in Regulatory Affairs in Medicines and Health Products aims to prepare highly qualified professionals in regulatory affairs related to the field of medicine, medical devices, cosmetic and personal hygiene products and food supplements, to work in the different areas of regulatory affairs. The programmatic contents of Module 3 aim at the acquisition of skills regarding the regulatory aspects of the circuit and support document for the marketing of a medical device with CE registration.
Teaching Methodologies (Including Evaluation):
The teaching regime of the Postgraduate Course in Regulatory Affairs of Medicines and Health Products is distance learning (online), through the CANVAS platform. The course will be assessed through attendance and participation during each session of the course and the presentation of a final paper/report on one of the topics taught during the course. The topic of the work will be selected by the student himself according to student`s professional interests.
Demonstration of the Coherence between the Teaching Methodologies and the Learning Outcomes:
The evaluation in each module of the course will be carried out by the presence and interest/participation during each session. The final evaluation of the course through a final work/report will validate the scientific competencies and the systematisation of the knowledge acquired by the students. Additionally, the completion of this work / final report allows to deepen the knowledge in a more specific area of the course according to professional interests.
Reading:
MEDDEV 2.7.1 rev 4 and Clinical Evaluation Reports (CER) for Medical Devices (2016) INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I. P. webpage - https://www.infarmed.pt/