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

Registration

You need an unlock code for this registration:

Send

Participant

Title

First NameRequired

Family NameRequired

Company or InstitutionRequired

Department

Street and house numberRequired

Post CodeRequired

CityRequired

CountryRequired

other country

E-MailRequired

Second E-Mail (optional)

PhoneRequired

Further Information

Yes, I would like to receive invites to similar events or relevant news about the topic via email or mail from the VDE group.

By selecting "yes" you agree that your personal data may be processed by VDE e.V. and its affiliated companies (hereafter referred to as the "VDE Group") for invitations to events and information within the framework of statutory purposes (e.g. seminars, conferences, excursions, lectures, campaigns, newsletter).

Choose Ticket

TicketRequired

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

If you have chosen an option for VDE members only, please insert your membership number, which is a 7-digit number. It starts with a 3 or a 6. In the case of invalid membership numbers, we reserve the right to cancel your booking at a charge.

VDE - Membership Number

Privacy Regulations

Notes:

Information on how VDE handles your personal data, the purposes for which your data is processed, the legal basis for the processing and what rights you have can be found at https://www.vde.com/en/privacy-statement.

Registration for events is carried out by the service provider "eveeno" as a processor. You can find the privacy policy of eveeno here.

Terms of Participation

The event takes place as an online event. The price includes the participation fees.

Other fees for the use of an Internet connection may be charged to you by your telecommunications provider.

Please note the terms and conditions for events

Terms and conditions for eventsRequired

I have read and understood and agree to the terms and conditions for events.

Cancellation deadlines and fees

Cancellations can only be made in text form and are possible up to 8 days before the date of the event. 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.

The event was brought to my attention by...

E-Mailing from VDE Note from colleagues Search on the Internet

Other

Do you have a promotion code?

Enter promotion code, if available

Send No, I do not have a promotion code

Your selection

Invoice address

Specify billing address

Company or institution

Title

First name

Last name

Street and house number

Zip code

City

Country

VAT ID

Your reference (e.g. order number)

Payment method

SEPA wire transfer
Get an email with the bill, then make a SEPA bank transfer and get the confirmation later, as soon as the money arrives. The bill has to be paid immediately.

SEPA wire transfer
Get an email with the bill and the confirmation, then make a SEPA transfer for the event fee. The bill has to be paid immediately.

Online payment
Pay with PayPal, Sofort or credit card.

« Go back and modify registration

Info

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.

The event will take place as an online event via Microsoft Teams.

The event will take place with a minimum of 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 working days before the event date. Thank you for your understanding.

This online event will not be recorded and therefore cannot be made available at a later date.

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.

Payment will be processed by eveeno on our behalf:

eveeno
Andreas Bothe
Ellenbogen 8
D-91056 Erlangen
Phone: +49 157 57 00 00 59
E-Mail: info@eveeno.de
Sales tax ID: DE262038183

Registration »