Formations et événements

This training session is aimed at those in charge of legal affairs within medical devices companies. It will provide an overview of manufacturers and distributors’ obligations and the main MDR provisions that may impact the day-to-day job of Legal professionals, including in relation to claims / promotion and contracts of different natures.

Réservé membres beMedTech

This session will give a high level summary of the upcoming IVD Regulation 2017/746. It will give sufficient information for importers and distributors to understand the issues that manufacturers are facing. Nevertheless, the focus of the session is on the specific impact of the IVD Regulation on importers and distributors. It will address the obligations that the IVD Regulation is directly imposing on importers and distributors : registration requirements, handling and reporting of complaints and incidents, the impact on distribution agreements and on internal procedures, etc... It will also pay attention to business risks, resulting from the IVD Regulation.

All medical devices companies process personal data. Since the adoption of the General Data Protection Regulation (GDPR) in May 2018, businesses are facing many challenges and must adapt their data protection practice in order to avoid significant fines imposed by authorities in case of non-compliance or data breaches. This presentation – focused on the Life Sciences sector – will provide an update on the most recent trends, guidelines and recommendations since the adoption of the GDPR. It will also cover the relevant provisions under the Belgian Act of 30 July 2018 implementing the GDPR. The presentation will finally address some data privacy challenges when using new technologies, such as blockchain