Approval of software as medical device in Europe: Overview of the requirements and insights from practice (Online)

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Online Participation: VDE Members only 630,00 € Online Participation (Non-Member) 700,00 € Free Booking by Organizer

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Description

Manufacturers of software with a medical intended purpose are subject to many laws and other regulations in Europe. These are primarily the Medical Device Regulation (MDR) and the In-vitro Diagnostic Medical Devices Regulation (IVDR). Manufacturers must also comply with the relevant guidelines and technical standards. In addition, there are requirements from horizontal EU legislation such as the Artificial Intelligence Act (AIA) or the existing General Data Protection Regulation (GDPR) as well as from national legislation such as the Medical Devices Implementation Act (MPDG) in Germany.

In this event, you will receive an overview of the requirements to be complied with from relevant laws, standards and directives. The theoretical basics will be supplemented by practical examples from the professional activities of the expert Dr Thorsten Prinz (VDE). The event format offers sufficient time for your questions and discussions.

The presentations will be given in German. You will receive all presentation files as PDF (in English). As a special bonus, all participants of this event will receive a list of the requirements for medical devices as high-risk AI systems in accordance with the provisions of the Artificial Intelligence Act in PDF format.

We are looking forward to your participation!

Agenda

08:55	Registration
09:00	Welcome and introduction Thorsten Prinz, VDE
09:15	Regulatory requirements for software as a medical device in Europe (Part 1) European legal framework (incl. AI Act) Medical device software Risk classification Manufacturer obligations Important standards Quality management system Risk management system (incl. safety and cybersecurity)
10:45	Coffee break
11:00	Regulatory requirements for software as a medical device in Europe (Part 2) Clinical evaluation and investigation Product requirements (incl. for AI-based medical devices) Software life-cycle processes (including AI-specific aspects) Usability Technical documentation Information supplied by manufacturer (incl. AI-specific aspects) Person responsible for regulatory compliance (PRRC)
12:15	Lunch break
13:15	Regulatory requirements for software as a medical device in Europe (Part 3) Conformity assessment Declaration of conformity CE marking Registration of product and manufacturer European Database on Medical Devices (EUDAMED) Post-market surveillance (PMS), Post-market clinical follow-up (PMCF), and vigilance
14:45	Discussion
15:15	End of event

Preliminary program. Subject to changes / adjustments

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The event is organized for at least 4 participants. If the minimum number of participants is not reached one week before the start of the event, we reserve the right to cancel it. For organizational reasons, registration for our events usually closes 3 days before the event date. Thank you for your understanding.

Cancellations can only be made in text form and are possible up to 8 days before the event date. In this case, a cancellation fee of 25% of the ticket price will be charged and retained when the amount paid is refunded.

This means that 100% of the ticket price will be due in the event of a short-notice cancellation of 7 days or less.

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