2026-02-27 2026-02-27 , online online, 1,290 € zzgl. MwSt. Jürgen Mehring https://forum-institut.de/seminar/26072301-eu-requirements-for-labelling-udi-product-information/referenten/26/26_07/26072301-eu-requirements-for-labelling,-udi-product-information_mehring-juergen.jpg EU Requirements for Labelling, UDI & Product Information

Compact overview of EU requirements for labelling, UDI and product information under the MDR. Learn how legal obligations translate into practical workflows, including UDI allocation and EUDAMED device registration. Ideal for RA, QA and labelling professionals.

Topics
  • EU labelling and product information requirements
  • Mandatory MDR elements, symbols and language rules
  • Practical workflows for labels, IFUs and artwork
  • UDI allocation and data governance
  • EUDAMED UDI module essentials
  • Common pitfalls and best-practice implementation


Who should attend
This seminar is designed for professionals involved in labelling, product information, UDI management and regulatory compliance for medical devices in the EU. It is ideal for those who translate regulatory requirements into operational processes or oversee MDR-compliant documentation and data.

  • Regulatory Affairs Manager
  • Quality Manager / QA Specialist
  • Labelling / Artwork Specialist
  • UDI / Master Data Manager
  • Compliance or Documentation Specialist
Aims and objectives
The aim of this seminar is to provide participants with a concise overview of the EU requirements for labelling, UDI and product information, and to translate these into practical implementation strategies.

You will gain both legal guidance and hands-on recommendations to ensure MDR-compliant processes, UDI data and EUDAMED submissions.
Your benefit

Participants gain a clear understanding of the EU regulatory framework for labelling, UDI and product information, along with practical tools for effective implementation. The seminar provides actionable insights to strengthen compliance, improve internal processes and prepare for audits and EUDAMED submissions.

26072301 EU Requirements for Labelling, UDI & Product Information

EU Requirements for Labelling, UDI & Product Information

From regulatory obligations to operational best practices for medical device compliance

Benefits
  • incl. EUDAMED UDI module essentials
  • EU labelling requirements
  • Practical UDI implementation
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 26072301

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Alles auf einen Blick

Termin

08/07/2026

08/07/2026

Zeitraum

9:00 am - 4:30 pm CET/CEST
You may dial in 30 min in advance

9:00 am - 4:30 pm CET/CEST
You may dial in 30 min in advance
Veranstaltungsort

online

online

Gebühr
Your contact

Dr. Myriam Friedel
Conference Manager

+49 6221 500-563
m.friedel@forum-institut.de

Details

Compact overview of EU requirements for labelling, UDI and product information under the MDR. Learn how legal obligations translate into practical workflows, including UDI allocation and EUDAMED device registration. Ideal for RA, QA and labelling professionals.

Topics

  • EU labelling and product information requirements
  • Mandatory MDR elements, symbols and language rules
  • Practical workflows for labels, IFUs and artwork
  • UDI allocation and data governance
  • EUDAMED UDI module essentials
  • Common pitfalls and best-practice implementation


Who should attend
This seminar is designed for professionals involved in labelling, product information, UDI management and regulatory compliance for medical devices in the EU. It is ideal for those who translate regulatory requirements into operational processes or oversee MDR-compliant documentation and data.

  • Regulatory Affairs Manager
  • Quality Manager / QA Specialist
  • Labelling / Artwork Specialist
  • UDI / Master Data Manager
  • Compliance or Documentation Specialist

Aims and objectives

The aim of this seminar is to provide participants with a concise overview of the EU requirements for labelling, UDI and product information, and to translate these into practical implementation strategies.

You will gain both legal guidance and hands-on recommendations to ensure MDR-compliant processes, UDI data and EUDAMED submissions.

Your benefit

Participants gain a clear understanding of the EU regulatory framework for labelling, UDI and product information, along with practical tools for effective implementation. The seminar provides actionable insights to strengthen compliance, improve internal processes and prepare for audits and EUDAMED submissions.

Detailed programme

9:00 am - 4:30 pm CET/CEST
You may dial in 30 min in advance

09:00 Welcome


09:15

Dr. Marc Oeben, LL.M.

Legal requirements for EU Labelling & Product Information
  • Mandatory label elements under the MDR
  • Legal definition and scope of Product Information (PI)
  • Regulatory requirements for symbols, language and readability
  • Responsibilities of manufacturers and economic operators

10:30 Coffee Break


10:45

Jürgen Mehring

Practical implementation of Labelling & Product Information
  • Practical application of symbols and PI elements in company processes
  • Ensuring readability and consistency in real-life labelling workflows
  • Structuring label and IFU content across packaging levels
  • Managing translations, artwork development and approvals
  • Typical implementation challenges and practical solutions

12:15 Lunch Break


13:15

Jürgen Mehring

Practical implementation of UDI & EUDAMED device registration
  • Responsibilities of manufacturers and economic operators
  • Relationship between UDI and product documentation
  • Internal workflows for allocating Basic UDI-DI and UDI-DI
  • Data governance and consistency across PLM/ERP systems
  • Walk-through of a Basic UDI-DI example
  • Mapping real product data to EUDAMED data fields
  • Preparing complete UDI and device datasets
  • Avoiding common industry pitfalls
  • Ensuring alignment between artwork, datasets, UDI and EUDAMED submissions
  • Typical findings from audits

15:00 Coffee Break


15:15

Dr. Marc Oeben, LL.M.

Legal Risk Management for UDI & Labelling: Enforcement, Liability and Contract Controls
  • Liability landscape for UDI & labelling failures
  • Liability implications of incomplete, misleading or non compliant labelling/PI
  • Use of AI-tools for labelling designs
  • Distance sales & marketing claims
  • Liability exposure & risk mitigation

16:30 End of Seminar


Workshops

In-house training on "Labelling / UDI"
Mittwoch, 08.07. - 08:00 bis 16:00 Uhr

Are you interested in an in-house training course on topic "Labelling / UDI "? Please contact us to find out more.

FAQ

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The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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We are now officially certified to ISO 9001 and ISO 21001 standard.

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