2024
Medical Devices
Name: Medical Devices
Code: CMS13756I
3 ECTS
Duration: 15 weeks/78 hours
Scientific Area:
Ciências Farmacêuticas
Teaching languages: Portuguese
Languages of tutoring support: Portuguese
Presentation
This UC presents the definition, classification and the different stages and processes of its life cycle, post- commercialization security and aspects related to commercialization, marketing and advertising, and the legislative framework and the requirements inherent to harmonization and brand.
Sustainable Development Goals
Learning Goals
The student must:
1. To know the concept and classification of medical devices (MDs);
2. To know the legislative framework at national and community level;
3. To recognize the role of agents involved in the MD's life cycle;
4. To know and understand the technical documentation;
5. To identify and understand the stages of the clinical investigation process;
6. To know and understand the aspects of manufacturing, distribution, marketing, coding and post-market surveillance;
7. To understand and apply commercial, marketing and advertising concepts to MDs;
8. To know and carry out the economic evaluation;
9. To know the digital aspect of MDs and MD-drug combinations.
1. To know the concept and classification of medical devices (MDs);
2. To know the legislative framework at national and community level;
3. To recognize the role of agents involved in the MD's life cycle;
4. To know and understand the technical documentation;
5. To identify and understand the stages of the clinical investigation process;
6. To know and understand the aspects of manufacturing, distribution, marketing, coding and post-market surveillance;
7. To understand and apply commercial, marketing and advertising concepts to MDs;
8. To know and carry out the economic evaluation;
9. To know the digital aspect of MDs and MD-drug combinations.
Contents
- Applicable european and national legislation;
- Definition and classification of MDs, border demarcation;
- Essential requirements and harmonized standards;
- CE marking;
- Role of the Competent Authority and the Notified Body; sector associations;
- Support documentation for a MD;
- CE Declaration of Conformity, CE Certificate of Conformity and Labeling of MDs;
- Risk management;
- Clinical investigation: principles of clinical evaluation, stages of the clinical evaluation process and documentation requirements; post-market clinical monitoring requirements (PMCF) and requirements for a clinical evaluation report (CER);
- Manufacture of MDs;
- Good MD Distribution Practices;
- MD marketing requirements;
- National and hospital coding of MD;
- Post-market surveillance;
- Commercial Compliance: advertising and promotion of MDs; scientific events;
- Concepts of economic evaluation applicable to MD;
- Health apps and software like MD;
- Drug / Device and Device / Drug combinations.
- Definition and classification of MDs, border demarcation;
- Essential requirements and harmonized standards;
- CE marking;
- Role of the Competent Authority and the Notified Body; sector associations;
- Support documentation for a MD;
- CE Declaration of Conformity, CE Certificate of Conformity and Labeling of MDs;
- Risk management;
- Clinical investigation: principles of clinical evaluation, stages of the clinical evaluation process and documentation requirements; post-market clinical monitoring requirements (PMCF) and requirements for a clinical evaluation report (CER);
- Manufacture of MDs;
- Good MD Distribution Practices;
- MD marketing requirements;
- National and hospital coding of MD;
- Post-market surveillance;
- Commercial Compliance: advertising and promotion of MDs; scientific events;
- Concepts of economic evaluation applicable to MD;
- Health apps and software like MD;
- Drug / Device and Device / Drug combinations.
Teaching Methods
Theoretical teaching will be essentially expository. Indirect (constructivist) teaching will also be developed, both in theoretical classes and in theoretical-practical classes.
The evaluation will be divided into two stages:
1. Continuous assessment:
- Theoretical (60%), theoretical test at the end of the semester;
- Theoretical-practical (40%), group work.
For approval, the student must obtain a weighted average of 9.5 or more.
2. Evaluation by final exam (100%).
For approval, the student must obtain a rating equal to or greater than 9.5 values.
The evaluation will be divided into two stages:
1. Continuous assessment:
- Theoretical (60%), theoretical test at the end of the semester;
- Theoretical-practical (40%), group work.
For approval, the student must obtain a weighted average of 9.5 or more.
2. Evaluation by final exam (100%).
For approval, the student must obtain a rating equal to or greater than 9.5 values.
Certificações
