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Following the success of the “Expert Course in Regulatory Affairs 2022-2023” regarding the new Regulations on medical devices (MP) and in vitro diagnostic (IVD) medical devices 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, the Basque Health Cluster is launching the second edition of the same. However, this second edition, “Expert Course in Regulatory 2.0”, is full of novelties!

Unlike the previous course, this is a practice-oriented course; it consists of 27 lessons, of which 20 are workshops with the aim of putting students to work. The remaining 7 are theoretical classes focused on providing basic theoretical knowledge to people who are not familiar with the regulatory framework applicable to MD and IVD products.

We have a panel of the best experts in the field, including the Spanish Agency for Medicines and Medical Devices (AEMPS) and the National Centre for the Certification of Medical Devices (CNCPS).

In addition, we have incorporated a specific module on the procedure for obtaining FDA certification and access to the US market, also offering a workshop with real company experiences.

Program

Context:

On 26 May 2021 the Medical Devices Directive 93/42/EEC (MD) ceased to be in force and was replaced by the new European Medical Devices Regulation 2017/745 (MDR). Likewise, on 26 May 2022 the Directive 98/79/EC on in vitro diagnostic (IVD) medical devices was also replaced by the new European In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).

These changes have meant an important qualitative leap that affects all intervening agents (manufacturers, subcontractors, authorised representatives, importers, distributors, Notified Bodies, specialised consultancies…), including changes in the classification rules and in the product dossier, greater demands in clinical evaluations, greater stringency in the processes of placing on the market, as well as in post-marketing surveillance. With the entry into force of the new regulations, the Notified Bodies require and verify that the technical manager of the manufacturing company has the required training to carry out their activities and must also monitor their training plans during audits.

Thus, both Regulations introduce more stringent requirements for the certification of MD and IVD products, and there is a strong need for access to Notified Bodies (NBs) to certify these products. However, we are currently in a worrying situation with regard to the shortage of NBs adequately trained to certify companies’ products as the implementation of the new Regulations has led many NBs to either withdraw their services or inhibit their activity in the market due to the complexity of the process and the increased legal risks that may be involved for any failure in their work.

The lack of access to specialised NBs in the field means that many companies are unable to comply with the certification requirements, resulting in a decrease in the supply of medical devices and limitations in the ability of companies to operate in the market.

Objective:

In this context the course aims to meet the criteria required for compliance with the new European MDR and IVDR regulations. In this way we aim to provide the necessary knowledge, skills and competences to deal with the regulatory framework throughout the life cycle of products in accordance with the new regulations.

Likewise, in this edition of the “Expert Course in Regulatory 2.0″ we want to offer basic knowledge on the marketing of medical devices in the USA through FDA, also offering a workshop with real experiences of companies”.

Methodology:

Classes are face-to-face. The format of the course will be a combination of theory and practice through lectures and group workshops. Theoretical classes are rather focused on providing students with the most basic and necessary concepts to approach the corresponding workshops, as these are aimed at people who are already familiar with or working in the regulatory framework of medical devices within their entities.