Last places on the “Expert on Regulatory Affairs” course

Basque Health Cluster organizes an intensive course on the new Regulations for medical devices (MD) and in vitro diagnostic medical devices (IVD) under the new European Regulations (EU) 2017/745 and 2017/746 of the European Parliament and of the Council of 5 April 2017 on this type of products.

Context:

The entry into force of the new European Regulations 2017/745 (MDR) and 2017/746 (IVDR) and the compliance with the requirements for certification under them, entail many difficulties and changes that affect the different intervening agents of MD and IVD in Europe. On the one hand, the certification process requires very long standard deadlines and there is a shortage of Notified Bodies accredited under the MDR and IVDR; this leads to a serious situation of collapse in certification, making it impossible to market many products. On the other hand, there are changes regarding the classification rules and requirements in the elaboration of the product dossier, more stringent requirements in clinical evaluations, greater rigor in the processes of placing on the market, as well as in post-market surveillance and the requirement to assign a technical responsible with the required training to develop the activities in the regulatory framework.

So, the “Expert course on regulatory affairs” is created to meet the criteria required by the adaptation of the new European MDR and IVDR regulations, aiming to provide the knowledge, skills and competencies necessary to address the regulatory framework throughout the life cycle of mof the companies and in accordance with the new regulations.

Calendar and location:

The course begins on April 28 with the presentation of the course, and ends on February 10, 2023. It is divided into three parts, and a total of 8 different modules, plus the start and end of the course. The 8 modules are as follows; Quality Management; Regulatory Framework; Design, Development, and Production; Usability Evaluation; Clinical Evaluation; Clinical Trial Management; Commercialization; and Post-Marketing. It is possible to enroll in the modules independently, without taking the course as a whole.

The course follows the combined methodology of theory and practice through lectures and group workshops. Classes will be held on Fridays, from 09:30 to 13:30, at BIC Bizkaia: Camino Astondo, Edificio 612, 48160 Derio, Parque Científico y Tecnológico de Vizcaya.

Lecturers: