Regulatory affairs for medical devices

The objective of the course is to introduce students to the regulatory framework relating to medical devices.

The objective of the course is to introduce students to the regulatory framework relating to medical devices. The course will present the European regulations for medical devices as well as the requirements of ISO 13485 for quality management. The course will present the content of the technical documentation for a medical device to meet the requirements of the CE marking according to European regulation 2017/745.

Proposed content :

• Stakeholders in the medical devices sector: competent authorities, notified bodies, manufacturers, distributors, etc., roles and relationships, market surveillance
• The medical device market: global, European, Belgian markets, leading companies
• Medical device classification: classification rules according to European regulations (+ FDA)
• CE marking: route for marking, access to the market
• European Regulation 2017/745: analysis of the text and annexes
• Technical documentation: the various components of this technical documentation (risk management file, responses to performance and safety requirements, list of applicable standards, etc.)
• Requirements of the ISO 13485 standard

By the end of the course, students will be able to :

• Identify correct references (regulations, standards, CE, FDA, …) for a given clinical issue or technical need set out by a health professional
• Apply the CE classification rules of a medical device
• Describe the roles of the different stakeholders in the medical device industry and the impact the regulatory framework has on the development of medical devices
• Draft the technical documentation for a medical device based on a proposed outline
• Communicate effectively, in writing, project results based on a proposed proforma of a technical report

The course will be divided into two teaching activities.

Activity #1 - 48h : Theory and case studies

24 theoretical/practical sessions (2h by session) on the content described above.

Activity #2 - 12h : Project

Students, alone or in group, are asked to take up a challenge, perform a task and/or produce an achievement. The students will be accompanied through all the process by the teachers taking the role of tutors.

Références, bibliographie et lectures recommandées

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices, 2008, Tobin & Walsh.

Medical device design: innovation from concept to market, Ogrodnik, Elsevier Academic Press.

Biodesign : the process of innovating medical technologies, Zenios, Makower & Yock, Cambridge University Press.

Contacts

Contacts

Kyun THIBAUT (kthibaut@covartim.com)

Campus

Autre campus

Méthode(s) d'évaluation

• Projet
• Examen oral

Projet

Examen oral

Evaluation weight :

• Oral exam : 60%
• Project : 40%

Langue(s) d'évaluation

• anglais