When labeling a product, all legal requirements must be taken into account: packaging (e.g. labels), the device itself (e.g. symbols, markings), instructions (e.g. instructions for use), and accompanying materials (such as brochures) must all comply with the applicable regulations.
In addition to these labeling requirements, the new EU regulations for medical devices and IVDs have been in effect since May 26, 2021 (MDR) and May 26, 2022 (IVDR), respectively. These regulations make the introduction and implementation of Unique Device Identification (UDI) for medical devices mandatory within the EU.
To provide you with first-hand information, we are organizing this seminar in cooperation with GS1 Austria, the official UDI issuing agency in Europe.
Participants
This seminar is not suitable for participants without prior knowledge. Basic knowledge of the MDR or IVDR is recommended.
The seminar contents
- MDR – Requirements for UDI:
- Overview UDI
- UDI interfaces (quality management, production, other business processes)
- UDI as part of EUDAMED
- Labelling – Requirements for Packaging, Device, Instructions, and Accompanying Materials
- ISO 15223-1:2017
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied - EN ISO 20417:2021 Medical devices – Information to be supplied by the manufacturer
- Language requirements for labelling
- ISO 15223-1:2017
- Steps for the successful implementation of UDI
- UDI award rules
- UDI labeling rules
- Barcode quality
- Barcode check
- Master data management
- Master data exchange
Your trainers:
DI Martin Schmid, Managing Director & Senior Consultant en.co.tec
Poppy Abeto Kiesse, MSc., Business Development Manager Healthcare bei GS 1 Austria GmbH
Information about our trainers
Costs
1 day in-house training: Euro 3.790,- (excl. VAT) for max. 10 participants; incl. seminar documents and certificate of attendance, plus travel expenses.
Book now:
Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491
