Formations et événements

The presentation will identify the changes brought by the MDR, focusing on the independent obligations of distributors but also how they relate to other economic operators for MDR compliance. It will address the requirements imposed by the MDR both in the pre-marketing and the post-marketing phases and is primarily intended for all economic operators distributing medical devices in the European Union.

It is intended for software manufacturers – of all sizes – who would like to know more about their products status, how they qualify under the new MDR rules (is it a medical device or not?) and how they can be classified (in which class does it fall). The training will also provide an overview of the main MDR changes and address a set of basic requirements regarding Medical Device Software beyond qualification and classification.

This is the first part of the training course on health economic evaluations which is specifically oriented to the MedTech sector. The second part will be held on 29/10/2020 from 13:00-16:00. You have to register for both sessions. You will find more information in the brochure.

This is the second part of the training course on health economic evaluations which is specifically oriented to the MedTech sector

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