MedTech Summit 2022

MedTech Summit 2022
June 29, 2022

MedTech Summit 2022

ARTICLE BY: Marjeta Tušek Jelenc
CATEGORY: Regulatory Compliance

The MedTech Summit is one of the biggest and most important regulatory events of the year in the medical device industry. It brings together hundreds of Competent Authority, Notified Body and industry experts to discuss the evolving regulatory landscape. This year it took place as a hybrid event (in person in Dublin, Ireland, and also virtually) between 20 and 24 June 2022. MedTech Summit 2022 features 9 prominent tracks covering everything needed to help regulatory professionals navigate, accelerate and maintain regulatory compliance:  EU MDR. IVD Regulation and Strategy. Software and AI. Law and Compliance. Post Market Surveillance & Vigilance. Clinical Evaluations & Investigations. Global Market Regulations. Biocompatibility. Drug Device Combination and Borderline Products. The event has more than 140 speakers.  

The SBAS team attended a virtual two-day event. Since we are a manufacturer of medical devices using advanced machine learning algorithms to provide different AI models for predicting the most probable diagnoses, we were especially interested in the Software, AI and Clinical Evaluations & Investigations topics. We are happy we gained more information on the EU regulatory framework on AI in healthcare, how to tackle duplication of legislation and risks of grey areas, to see Regulators Perspective on Clinical Evaluations and Investigations and how to create a successful clinical evaluation strategy. We also participated in fruitful discussions such as How the MDR and IVDR are Impacting European Market Access and Insights into the European Health Data Space. 

The field of artificial intelligence is developing extremely fast, so it is essential that as manufacturers, we follow all new requirements, appropriately prepare and update the technical documentation and procedures, and finally protect all health data. And an event like the MedTech Summit can provide great support.

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