Cyfrowy Paszport Produktu Medical Devices
Wszystko, co musisz wiedzieć o wymaganiach Cyfrowego Paszportu Produktu dla sektora Medical Devices w ramach rozporządzenia ESPR UE.
Wymagane pola DPP
Te pola są obowiązkowe dla produktów Medical Devices zgodnie z rozporządzeniem ESPR. Każdy Cyfrowy Paszport Produktu w tym sektorze musi zawierać te dane.
- device_classification
- material_composition
- country_of_manufacture
- udi_number
- ce_marking
- sterilisation_method
- biocompatibility_data
- chemical_compliance
Opcjonalne pola DPP
Te dodatkowe pola są zalecane dla produktów Medical Devices. Ich uwzględnienie poprawia kompletność Cyfrowego Paszportu Produktu i może podnieść wyniki zgodności.
- certifications
- carbon_footprint
- recyclability_score
- end_of_life_instructions
5-Step Plan for Medical Devices DPP Readiness
- Inventory your medical devices product range. List every SKU sold into the EU with category, materials, and current data quality.
- Map applicable data fields. Use the ESPR working plan to identify the likely DPP fields and align internal systems to feed them.
- Engage suppliers on data gaps. Material composition, substance, and origin data depend on supplier cooperation. Issue formal data requests now.
- Run a DPP pilot. Choose one product family, build the full passport, test the QR carrier, and use the pilot to flush out operational gaps.
- Set up governance. Assign clear ownership for DPP data quality, update cadence, and registry integration as the delegated act approaches.
Najczęściej zadawane pytania
What is a Digital Product Passport for Medical Devices?
A Digital Product Passport (DPP) for Medical Devices is a mandatory digital record required under the EU's ESPR regulation. It contains information about materials, sustainability data, compliance status, and supply chain traceability for medical devices products.
When is the ESPR deadline for Medical Devices?
The ESPR compliance deadline for Medical Devices products is 01 Jun 2029. Businesses must have Digital Product Passports in place by this date.
How many fields are required in a Medical Devices DPP?
Medical Devices Digital Product Passports require 8 mandatory fields and 4 optional fields. Required fields include core product data, materials composition, and sustainability metrics specific to the medical devices sector.
When do Medical Devices DPPs become mandatory?
The Medical Devices delegated act under the ESPR sets the mandatory compliance date, typically with an 18 to 24 month transition period after adoption. Track Commission publications for the specific date applicable to Medical Devices.
Does the DPP apply to non-EU Medical Devices producers?
Yes. Any Medical Devices product placed on the EU market requires a DPP regardless of where it is manufactured. Importers carry responsibility for ensuring DPP data is in place and registered.
How is the DPP linked to the product physically?
Through a data carrier, typically a QR code, RFID tag, or NFC chip on the product, packaging, or accompanying documentation. The carrier resolves to the DPP via a unique product identifier.
What is the EU DPP Registry and when does it launch?
The EU DPP Registry is the central federated index for all Digital Product Passports placed on the EU market. It is expected to be operational by 19 July 2026.
How can Medical Devices producers prepare now?
Inventory your product range, map data sources, engage suppliers on data quality, choose a DPP hosting model, assign unique product identifiers, and run a pilot DPP on one product line before mandatory compliance dates arrive.
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