Overview

This webinar delves into the regulatory landscape of Active Implantable Medical Devices (AIMDs) under the European Union Medical Device Regulation (EU MDR). It provides an in-depth analysis of the classification, conformity assessment procedures, and the essential requirements for AIMDs, emphasizing the importance of compliance for manufacturers aiming to market their products within the EU.

The session covers critical aspects, including technical documentation, clinical evaluation, and the role of Notified Bodies in the certification process. Aimed at professionals in the medical device industry, this webinar offers valuable insights into navigating the complexities of EU MDR for AIMDs. Whether you're involved in design, quality assurance, or regulatory affairs, this session equips you with the knowledge to effectively manage the compliance challenges associated with AIMDs under the EU MDR.

Key takeaways and learning objectives

• Active Implantable Medical Devices at BSI.

• Technical documentation requirements under the EU Medical Device Regulation.

• Obstacles for BSI as a Notified Body.

• Evidence to support active implantable medical devices when submitting documents for application.

Speaker

Thomas Doerge, Global Head Active Implantable Medical Devices