🇨🇿 Medical Devices in the PPWR Era: Packaging, Labels, Roles, and Responsibility

The event is held in Czech language only!

The new Regulation (EU) 2025/40, commonly referred to by the acronym PPWR, replaces Directive 94/62/EC and harmonizes the rules for all packaging and packaging waste placed on the EU internal market.

The legislation introduces entirely new terminology and definitions of roles, including a newly defined role of “Manufacturer.” It introduces new stringent requirements, such as reducing packaging size to the absolute minimum and setting limits on the percentage of void space in certain types of packaging. It also establishes mandatory rules for recyclability, a minimum required content of recycled plastics, and significant restrictions on the use of substances of concern (PFAS and others). Other significant changes for the market include new targets for packaging reuse, extended producer responsibility, and the requirement for harmonized labeling to facilitate consumer sorting.

In this webinar, we will focus on the overlap between this new packaging regulation and the MDR and IVDR. Although the PPWR provides certain exemptions for medical devices, a substantial portion of the regulation also applies to products and packaging subject to the MDR or IVDR.

This webinar is designed specifically for manufacturers, importers, and distributors of medical devices to provide participants with a comprehensive overview of key changes, obligations, effectiveness dates, and areas of conflict with the MDR/IVDR regulations.

Who the webinar is for:

• All manufacturers and importers of medical devices and IVD devices

• All distributors of medical devices and IVD devices

• Private-label holders who have medical devices packaged under their own brand (private label)

• Distributors and e-shop operators in the medical device sector

• Staff responsible for packaging management, packaging reporting, and extended producer responsibility

• Staff responsible for packaging design

• Regulatory specialists and quality department staff

• Anyone who uses packaging materials for the transport and storage of medical devices

• Anyone who manufactures or markets packaging and wishes to expand their knowledge of this new legislation

Lecturers:

• Mgr. Aneta Dostálová

• Ing. Aleš Martinovský

Guest:

• Ing. Pavla Cihlářová (GS1)

Content:

• The basic principles of the PPWR, its objectives, timeline, and the phased implementation of individual obligations

• What types of packaging fall under the scope of the PPWR and how the regulation distinguishes between sales packaging, group packaging, and transport packaging

• Specifics of packaging for medical devices and in vitro diagnostic medical devices, including relevant exemptions and special regimes

• The individual roles under the PPWR and their relationship to the roles of manufacturer, importer, and distributor under the MDR and IVDR

• The obligations of the packaging manufacturer, importer, distributor, producer under the extended manufacturer responsibility regime, and, where applicable, the authorized representative

• Requirements regarding the composition, safety, minimization, and recyclability of packaging

• Requirements regarding the content of recycled material, the reuse of packaging, and the reduction of excessive packaging and empty space

• New rules for packaging labeling, providing information, and demonstrating compliance with PPWR requirements

• Registration, record-keeping, reporting, and other obligations under extended producer responsibility in individual Member States

• Practical implications of the PPWR for the packaging portfolio of medical devices, change management, technical documentation, validation, contractual relationships with suppliers, and the quality management systeme

Additional information:

• During the webinar, participants will have the opportunity to ask questions

• Each participant will receive a certificate of participation

• A PDF presentation will be sent to all participants

Participation fee:

• 3.900 CZK excluding VAT

• 100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant

Webinar hosted by:

• Porta Medica s.r.o.

  ID: 03301931, VAT: CZ03301931

  Registered office: Opletalova 1525/39, 110 00, Prague 1 - Nové Město