Medical Devices

Recommended Prerequisites

- Related areas: Pharmaceutical Technology, Pharmacology; Physiopathology, Pharmacotherapy;

- Generic skills: analysis and synthesis; information management; critical thinking; self-driven learning; theoretical knowledge application into practical problem solving; group research ability.

- Specific skills: to know intruments, devices, implants, in vitro reagents and similar materials, used to diagnose, prevent, treart diseases or other conditions;

- Linguistic skills: to dominate both portuguese and english languages with the purpose of fullfilling the course unit's objectives.

Teaching Methods

- Theorical lessons: lectures, supported by electronic means;

- Group assays: elaboration of a synthesis assay;

- Induction for student participation in scientific activities.

Learning Outcomes

- To understand the importance of the products that support in the prevention, diagnosis and control of diseases, lesions or deficiencies;

- To know the legal context in which medical devices are inserted;

- To acquire knowledge that will allow to act on any of the stages of these product's life cycle;

- To know how to adequately classify medical devices;

- To understand what are the necessary conditions to guarantee these products' quality.

Work Placement(s)

No

Syllabus

- Introduction to medical devices: what they are, what they do, and what context are they inserted in;

- Appliable definitions, including legislated ones;

- Legal context and applicability, national and european wise;

- Medical device classification: classes and categories, with multiple practical examples;

- Medical devices vigilance system: what it is, how it works and its relevance for health efficacy and safety;

- Pharmaceutical couseling and intervention on medical devices: general considerations and common practical examples in a community and hospital pharmacy context.

Head Lecturer(s)

Patrícia Sofia Cabral Pires

Assessment Methods

Assessment
Synthesis work: 100.0%

Bibliography

- Decreto-Lei nº 145/2009, de 17 de Junho;

- Guidelines on a Medical Devices Vigilance System, MEDDEV 2.12/1 Rev. 5 April 2007;

- Guideline for the classification of medical devices, MEDDEV 2.4/1, Rev 8, July 2001;

- Guidelines related to the application of: the Council Directive 90/385/EEC on Active Implantable Medical Devices, the Council Directive 93/42/EEC on Medical Devices – Medical devices with a measure function, MEDDEV 2.1/5 June 1998;

- Guideline for definitions of “medical devices”, “accessory” and “manufacturer”: Guidelines related to the application of: the Council Directive 90/385/EEC on Active Implantable Medical Devices, the Council Directive 93/42/EEC on Medical Devices, MEDDEV 2.1/1 April 1994;

- Outra bibliografia (fornecida).