FAQ

Frequently asked questions

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BRAINORITY Software GmbH
Vor dem Lauch 15
70567 Stuttgart
Germany

Digital product passport

Does our product need a QR code specifically, or can we use NFC or RFID?

ESPR does not mandate a single carrier. EN 18220:2026 treats QR Code, Data Matrix, NFC, HF RFID and UHF RFID as admissible technologies and provides selection criteria rather than a fixed choice. The binding requirement is set per product group in the applicable delegated act. QR is the pragmatic default for consumer and authority access; RFID and NFC earn their place in specific operational scenarios. We help you read the selection criteria against your actual production and logistics reality.

Do I own my data — and can I leave?

Yes, by design. The DPP ecosystem makes you, the economic operator, legally responsible for your passports; we keep you in charge accordingly. Built-in export produces XML and PDF for full lot documentation, and a documented handover workflow or custom export moves everything to a successor system. Leaving SecIdent is a documented path, not a negotiation.

Does SecIdent conform to the JTC 24 standards?

We build to align with the published standards (EN 18216, 18219–18223) and track the two pending ones (EN 18239, EN 18246). Nobody can honestly claim certified conformity yet: the standards are published but not yet harmonized, and revisions are possible. We say so — and we adapt when they change.

Are small and medium-sized enterprises (SMEs) exempt?

Not as a general rule. For specific requirements, the ESPR provides certain simplifications for SMEs, and the European Commission is required to offer support measures (such as guidelines, digital tools, and training). However, there is no general exemption from the DPP obligation.

Can non-EU authorities access my passport data?

No US-controlled provider is involved anywhere in our stack: SecIdent is developed and operated entirely in Europe, in German data centers, by a German company. There is no party in the chain through which the US CLOUD Act or similar extraterritorial laws could reach your data.

Should I build my own DPP solution or self-host my own implementation?

An honest assessment: building or self-hosting gives you full control, no license fees and an exact fit — and it can be the right call if you have a permanent team for it. Weigh against that: the regulation is a moving target (two standards pending, the Article 77 implementing act ahead, revisions signalled), the audit and validation burden, printing-line integration, registry connection, and liability sitting with you as economic operator. A passport platform is not a project that ends — it is a product that must be maintained for as long as your batteries live. Most manufacturers underestimate that second part. If you build: budget for regulatory tracking as a standing function, not a side task.

What distinguishes SecIdent DPP software from a simple product page?

A product page with a QR code simply displays information. A compliant DPP, however, must also provide structured, machine-readable data, adhere to standards and data carrier requirements, be connectable to the EU registry, and remain available over many years. SecIdent covers this entire framework—not just the presentation layer.

What is the fastest path to a first compliant Digital Product Passport?

Manual entry or import of the data you already have. Customers issue their first valid passport in weeks, then automate data flows and partner integrations where the volume justifies it. The bottleneck is rarely the software — it is collecting supply-chain data, and that starts whenever you do.

What is a Digital Product Passport (DPP)?

A structured digital dataset linked to a physical product via a data carrier, containing information on materials, hazardous substances, repairability, recyclability, and end-of-life handling. It is based on the EU Ecodesign Regulation (ESPR, Regulation (EU) 2024/1781).

What does a Digital Product Passport with SecIdent cost?

The base license starts at €490 per month, plus a volume component. The per-passport cost falls as volumes rise; we propose the most economical configuration for your case.

What distinguishes SecIdent as a DPP provider?

SecIdent is an established solution that has proven itself over many years in the highly regulated EU pharmaceutical context. It is ready for immediate use. It is not a prototype, beta version, or version 1.0.

In addition to the technical requirements for a DPP provider set by the EU, SecIdent offers advanced audit and validation options for maximum security and compliance. Digital sovereignty has always been a matter of course for us. We develop, operate, and host SecIdent 100% in Europe.

SecIdent has matured over many years and communicates seamlessly with printing systems, partner systems, and EU systems without the need for major integration projects. Thanks to its extended range of functions, which include geolocation, gray market detection, and document management, SecIdent also offers long-term added value beyond the pure DPP requirements.

What is the current development status of SecIdent's DPP solution?

Stable, established serialization and ID solution. Battery passports can be recorded and integrated into production immediately. Subject to the technical specifications from the EU, which are not yet final. These will be retrofitted as soon as possible (at no extra cost) as soon as they are available. The same applies to the connection and testing of the EC registry, which is expected to be available for the first time in summer 2026.

Which unique identifier scheme should we use for our Digital Product Passport?

There is no single correct answer — it depends on your value chain, not on which identifier you happen to already own. ESPR Annex III calls for a GTIN per ISO/IEC 15459-6 “or equivalent”, and EN 18219:2026 confirms that issuing-agency schemes (GS1, others), web-URI schemes (ISO/IEC 18975), registry schemes (LEI, DOI), and self-issued decentralized identifiers are all admissible. The right choice balances regulatory acceptance, downstream tooling, and 10-year-plus persistence. We work through that trade-off with each customer in our optional onboarding workshop rather than defaulting everyone to the same scheme.

If we leave SecIdent, what happens to our passports?

Your data and your resolver domain remain yours. The DPP ecosystem is decentralized by design, and you, as the economic operator, are responsible for your passports, so SecIdent is built to let you export your data and move your resolver elsewhere. We treat that as a requirement of the regulation, not a concession.

How does SecIdent assist in determining the necessary data and attributes?

SecIdent helps customers identify relevant data sources in their supply chain, assign attributes at batch and type label level, and structure data flows step by step, without requiring full ERP integration beforehand. The experience gained from over a decade of regulated data processes (including pharmaceutical serialization in accordance with 2011/62/EU) flows directly into this consulting service.

We don't have a GTIN. Can we still issue a compliant product passport?

Yes. A GTIN via a GS1 Company Prefix is inexpensive and quick to obtain, and it remains the best-supported default. Where your value chain is standardised on a different identifier system, EN 18219 admits alternatives. The decision is part of onboarding, not a blocker. We make sure you pick a scheme that the EU registry and your supply-chain partners will actually accept.

Battery passport

When is the battery passport mandatory, and which batteries need one?

From 18 February 2027, every EV battery, every LMT battery and every rechargeable industrial battery above 2 kWh placed on the EU market needs a digital battery passport, accessible through a QR code on the battery (Regulation (EU) 2023/1542, Article 77).

Is the QR code mandatory on the battery itself, or may it go on the packaging?

On the battery. Article 13(7) of Regulation (EU) 2023/1542 requires the QR code to be printed or engraved visibly, legibly and indelibly on the battery; placement on packaging or accompanying documents is permitted only where the nature and size of the battery make on-product marking impossible or unwarranted. For EV, LMT, and industrial batteries over 2 kWh that QR code must resolve to the battery passport under Article 77.

Production/Manufacturing

Can I process the DPPs/serial numbers with my existing printing system?

Almost certainly, yes. If the printing system is unable to retrieve the codes from the SecIdent interface, you can actively transfer them. This works particularly well if the printing system itself does not have an internet connection.

We already have templates for some printing systems. These include:

  • Antares Vision

  • Argus Sensorsysteme

  • Bluhm Systeme

  • HSA

  • Mettler Toledo

  • OCS Wipotec

  • Paul Leibinger

  • REA Jet

  • Uhlman

New integrations can be quickly implemented using configurable workflows. SecIdent adapts to your printing systems, not the other way around.

Do I need to retrofit my production line to print DPP-compliant codes?

No. SecIdent feeds standard 2D-capable printing and marking systems and has integrated packaging and printing lines since 2012. If your labels or nameplates are produced externally, we integrate your label partner — or deliver compliant nameplates together with Sommer GmbH.

Security & compliance

Are SecIdent’s unique IDs just random serial numbers?

Externally, you get unique IDs that serve as the serial numbers. Internally, each ID is derived cryptographically from a compact sequence rather than rolled at random: no collision checks across billions of codes, no database bloated with random numbers, and invalid or guessed codes are detectable. You notice the difference only at scale.

What happens to my data when I cancel SecIdent?

If you cancel SecIdent, your serial codes will no longer be verifiable online via the SecIdent web app.

However, before the contract period expires, you can export all serial numbers, metadata, and logs or transfer them directly to a successor system via workflow. There is no vendor lock-in.

Collaboration

Do my partners also have to be SecIdent customers in order to exchange data?

No. Partners can retrieve serial numbers and metadata via API or transfer them via a configurable workflow (e.g., as an XML file). Furthermore, existing serial numbers can be imported from partners.

If your partner also uses SecIdent, additional functions for approval, process reliability, and logging can be used. However, this is not required.

Interfaces & formats

Which print/code formats does SecIdent support?

SecIdent can embed serial codes in any format for transmission and delivery. These include, for example:

  • GS1 Data Matrix Code
  • QR-Code
  • GS1 Digital Link als QR-Code
  • MAPP
  • SGTIN

What interfaces to existing systems (ERP, PLM, etc.) does SecIdent offer?

SecIdent specializes in adapting to existing system environments as much as possible and actively connecting with them. This usually saves time-consuming integration projects and costs that are difficult to calculate.

There are four basic levels for integration:

  • Systems communicate directly with SecIdent's RESTful JSON API.
  • You or we configure workflows in SecIdent that retrieve data from other systems or transfer it to them.
  • Systems store files in our File API Gateway (e.g., via SFTP), which SecIdent then processes.
  • We implement middleware in your environment that forwards data to/from SecIdent. Ready-made middleware is already available for numerous applications and printing systems.

Service & Support

Are service level agreements (SLA) offered?

SecIdent's basic licenses already cover a high level of availability and service quality. If you would like a separate SLA (e.g., for shorter response times or designated contact persons), we offer this at an additional cost.

How will I be helped if I need assistance?

SecIdent includes online help that explains how to use the software. In addition, there is detailed technical documentation for developers and external partners.

If you are unable to find the information you need in the manual, you can contact us via our ticket system and we will assist you with your request.

Optionally, our support team can also set up workflows for connecting to partners and printing systems.

BrainGate & EMVS

Do I need BrainGate?

Only if you submit packs to the EMVS yourself, which is the MAH. Most MAHs use it for automated master data, pack upload, updates and alerting. CMOs usually do not need it, since they do not submit to the EMVS, and a very small MAH can use SecIdent to export PackData files and upload them manually through the EMVO Gateway. SecIdent runs with or without BrainGate.

Do I need EU Hub access?

Yes, you must have successfully completed both the formal and technical onboarding processes at EMVS in order to use BrainGate. We are happy to assist you with the latter, from applying for certificates to commissioning BrainGate.

How is BrainGate better than a direct connection to the EMVS European Hub?

BrainGate simplifies the complicated authentication, encryption, and transmission mechanisms of the EU Hub and maps them to an easy-to-use, uniform RESTful API.

Furthermore, responses and alerts from the EU Hub can be received via numerous channels (HTTP, queue, email, etc.).

An intuitive user interface is also available for registering and updating product master data.

Can I integrate BrainGate into my existing serialization system?

Absolutely yes. The purpose of BrainGate is to enable easy connection to existing software without in-depth knowledge of the EU hub's interface mechanisms.

What are the technical and organizational requirements for BrainGate?

You must have successfully completed the formal and technical onboarding process of the EMVS. We will assist you with the latter or take care of it entirely.

We use RESTful JSON for the BrainGate interfaces. Your software must support this.

How is BrainGate set up?

Once you have completed the formal onboarding process at EMVS, we will assist you with technical onboarding and technical qualification for the EU hub. Once the connection has been successfully tested, we will support you with integration into your existing software and provide detailed interface documentation.

How is BrainGate billed and how much does it cost?

BrainGate is billed monthly. The price consists of a flat rate and a variable component based on the number of serial numbers. The price per serial number is also determined by the flat rate. The flat rate starts at EUR 300 plus VAT.

Verification

Why is SecIdent validation-friendly?

SecIdent significantly reduces the validation effort by providing complete validation documentation for each software release, guaranteeing your audit security. The system architecture supports compliance through a detailed rights and roles concept, complete logging, and structured approval processes.

SecIdent thus offers a legally compliant solution in accordance with the Falsified Medicines Directive 2011/62/EU, which relieves pharmaceutical companies of the high documentation burden and maximizes process reliability.

How can I check DPPs and serial numbers? Do I need an app?

DPPs and serial numbers can be verified online by scanning a QR code with any standard smartphone. No app is required.

For increased security, SecIdent can be installed as a progressive web app (PWA). The verification can also be integrated into your own apps (via API) or websites (via iFrame or API).

Pharmaceutical serialization

Can I leave and keep my data?

Yes. Your master data, batches and serials are yours. You can export them and move on with no lock-in.

How is SecIdent Pharma billed and how much does it cost?

SecIdent is billed monthly. The price calculation is based on the number of active serial codes. In addition, there is a fixed monthly flat rate, which is influenced by factors such as the number of products/users and the price per serial code.

Accordingly, the price varies depending on the package booked and the number of codes. All details can be found on our pricing page.

Billing DPP

Does the active-DPP fee run indefinitely?

It applies for as long as the passport stays live. A DPP has to remain available for the period the applicable product regulation requires, and the active fee covers hosting it, keeping it resolvable, and maintaining it against standards updates over that period. When a passport is retired and no longer needs to be available, its active fee ends.

Are add-ons required?

No. Middleware, the File API gateway, release validation documents and custom SLAs are optional and quoted to your case. The standard platform works without them.

What is the difference between a new and an active DPP?

A new DPP is charged once, when a passport is created and published. An active DPP is a much smaller recurring monthly charge for each passport that remains live and publicly resolvable. Publishing is a one-time event; keeping a passport available is an ongoing one.

What is included in the entry plan?

The monthly base covers platform access, a starting allocation of automation and integration capability (workflows, partner connections and DPP templates), and your per-DPP rate at that plan level. Higher plans lower the rate and raise those allocations. We confirm exactly what your plan includes in the quote.

What happens if I stop producing new DPPs?

You can downgrade your plan. Your existing passports keep running at a fraction of the cost, and you can reactivate a full plan at any time when you need to issue again.

If we leave SecIdent, what happens to our passports?

Your data and your resolver domain remain yours. The DPP ecosystem is decentralized by design, and you, as the economic operator, are responsible for your passports, so SecIdent is built to let you export your data and move your resolver elsewhere. We treat that as a requirement of the regulation, not a concession.

How do quotas work, and when do they save money?

A quota is a prepaid, fixed volume of new and active passports for a set monthly amount, at a discount on the equivalent per-DPP rate. It makes sense when you want a predictable invoice and can estimate your volume: you trade some flexibility for a flat, planable cost. Quotas are optional.

How and when are we billed?

Pricing is in euros and billed monthly. During onboarding you pay a reduced base fee and your published DPPs are not counted, so you can configure and test everything before regular billing begins.

Photo of Verena

Verena Vasilev

Product Passport Specialist & Strategic Communication