Are you a small or medium-sized (SME) manufacturer of medical devices or in vitro diagnostic medical devices? Have you placed or are you in the process of placing a medical device or in vitro diagnostic medical device on the EU market? The following workshop is reserved for you!
The Workshop
The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) and the European Health and Digital Executive Agency (HaDEA) have commissioned EY (Ernst and Young) to carry out a study on regulatory governance and innovation in the field of medical devices. In the context of this study, EY is organising an online workshop for “SMEs under the MDR and IVDR regulatory frameworks”.
This workshop will take place on Thursday 27 June from 10h00 to 13h00 (Brussels time, CEST).
Reserve your spot by clicking here!
Who is invited?
If you represent a small or medium-sized (<250 employees) manufacturer of medical devices or in vitro diagnostic medical devices and have placed / are in the process of placing a medical device or in vitro diagnostic medical device on the EU market, we highly encourage you to register for this event.
The main takeaways
The aim of this workshop is to bring together SMEs operating within ‘the EU medical device and in vitro diagnostic medical device regulatory framework’ to assess the most concrete challenges that smaller enterprises face, as key stakeholders in the system. This collaborative effort will provide a platform for sharing experiences, identifying key issues, and discussing potential solutions to support the growth and compliance of SMEs in this sector. The workshop will provide participating SMEs with the opportunity to discuss and address specific challenges they encounter at various stages of the certification process of medical devices and in vitro diagnostic medical devices in the EU and will explore best-practices and potential solutions to improve the regulatory system.
To ensure active participation of SMEs from across the EU, break-out groups for the workshop will be conducted in various languages, which will be determined based on participants' preferences. To facilitate this, each participant will be asked to indicate their preferred language on the registration form. This approach aims to make the workshop more inclusive and engaging for all attendees.
If interested in joining this initiative, please register by filling out the form. Your participation is much appreciated!
Please note that, due to limited capacity, registration does not guarantee an invitation.
DISCLAIMER: This information is provided in the interest of knowledge sharing and should not be interpreted as the official view of the European Commission, or any other organisation.