No more paper. Digital communication for every medical device!
Leading healthcare providers are taking a joint position: Manufacturer information will flow digitally, machine-readably and securely – on an open industry standard (AAS/IDTA & Digital Product Passport 4.0).
Understand the standardImagine that for every medical device in your organisation, across its entire lifecycle, all information and data were available to everyone involved (manufacturers, operators, users and others) in a format all of them can read.
The situation today
Information is everywhere – except where it is needed
Paper package inserts, PDF emails and scattered manufacturer portals cost time, create media breaks and, in an emergency, put patient safety at risk. The official reporting process to the authorities is only one part of the overall process – the essential communication still happens offline and through manual research.
Fragmented data
Every device, every manufacturer, every portal is different. No consistent, up-to-date data set for your hospital or your company.
Risk during recalls
Field safety notices arrive by letter or fax – with no proof that they actually reached the affected device.
Manual effort
Asset registers, records and documentation are maintained laboriously by hand instead of being served automatically.
Meeting legal obligations
Risk to patients, risk to operations, risk of a marketing ban, reputational damage, cost and liability.
What happens in today's process – and what gets lost
- Uncertainty about the further procedure after an incident report
- Parallel reports to manufacturer and authority create inefficient parallel processes
- Time lost through opacity about status, investigation, statements, risk assessment and outcome
- Difficult attribution of safety measures and manufacturer information that may affect further, similar models
- System breaks impede feedback from operators and users back to the manufacturers
Built on the open Industry 4.0 standard
The Asset Administration Shell (AAS) is the internationally standardised digital twin of an asset – DIN EN IEC 63278, backed by the Industrial Digital Twin Association (IDTA). The Digital Product Passport 4.0 builds on it: manufacturer- and sector-neutral, human- and machine-readable, with controlled, role-based access.
No vendor lock-in, no isolated solution – interoperability with your CAFM, CMMS and medical engineering software.
More technical background Hide
One data set · many recipients
- The manufacturer maintains the product passport once Manuals, field safety notices, change requests
- Asset Administration Shell (AAS) = single source of truth unambiguously referenced via UDI-DI & UDI-PI
- Operators · users · authorities access it digitally role-based, versioned, auditable
Imagine this once more: for every medical device, across its entire lifecycle, all information is available to everyone involved – manufacturers, operators, users, authorities – in a format all of them can read. No more analogue, no more paper. Digital communication instead, anytime and anywhere.
Safe, standardised & digital medical technology management – unambiguous, anytime, anywhere
Operators and users report directly and in a standardised way with reference to UDI-DI and UDI-PI. Manufacturers receive and send cases directly and in a standardised way, and steer the process. The master data registered by the manufacturer is published in a public catalogue.
Benefits for manufacturers, operators and users
End-to-end process digitalisation that automates compliance processes – one standard that benefits every side of the value chain. Sustainable, open, agile.
Simple, economically rewarding
- Low barrier to entry into digital service communication
- Lower documentation and compliance cost through the single source of truth
- Expensive analogue communication channels disappear
- Foundation for field service, predictive maintenance and after-sales
- New digital service business models
- A location advantage in global competition – especially for mid-sized companies
Less effort, more safety
- Consistent, up-to-date device information for every asset
- Automatic inventory and asset register maintenance
- Field safety notices delivered digitally, immediately, completely and acknowledged
- Reduced effort under the German MPBetreibV – regulation as a by-product
- Lower process cost, better planning reliability
- Sustainability & investment protection: lifetime, repair and spare part data for longer use
- Integration into CAFM/CMMS and medical engineering software
Everything that matters, right at the device
- Current instructions for use (eIFU) via QR or data matrix code on the device
- Reliable safety information without searching
- Training and induction material available in context
- Higher application safety
- More time for patients instead of documentation
- Authorities can focus on monitoring instead of administration
- Faster end-to-end processes
- Improved quality and patient safety
Analogue before – digital after
The benefit along concrete use cases in the daily work of providers, manufacturers and users.
Your benefit
Experience the future for real – in a walkable 3D room
The virtual show room makes tangible what the standard means in daily practice: click a device in the operating room, open its digital product passport, and pull up instructions for use, field safety notices and maintenance records right at the asset.
- Anaesthesia workstation
- Patient monitor
- Operating table & ceiling supply unit
- Surgical light
Placeholder: the click will later open the interactive Unity 3D show room.
Regulatory goals fulfil themselves almost by themselves
Clean, structured and durably available data serves the central requirements of medical technology – all the way to patient safety and sustainability – without additional bureaucratic effort.
Central provision of data for the European database on medical devices (EUDAMED), UDI traceability, electronic instructions for use, technical documentation and post-market surveillance.
Asset register, medical device log book and safety inspection records can be derived from the standard data.
Cyber security: an up-to-date asset inventory, supply chain security and digital security advisories including SBOM support the obligations under Art. 21 (implemented in Germany via the NIS2UmsuCG).
The EU-wide Digital Product Passport becomes mandatory in stages from 2026 (electronics from 2027, among others). Anyone adopting DPP 4.0 today is prepared.
Overcoming the critical mass – changing the market
Once leading providers require the established industry standard, further providers, manufacturers and authorities will follow. Bureaucracy and analogue formalities then fall away almost as a by-product of a digital standard. The initiative becomes a MedTech Safety Hub!
- 1 Innovation partners take a visible position and support the initiative
- 2 Manufacturers join in at a low threshold
- 3 A network emerges
- 4 Authorities adopt the standard
Become an innovation partner
Healthcare providers and MedTech manufacturers take a position as innovation partners – each with an agreed role, without formal membership.
For healthcare providers
You support the initiative and thereby create demand in the market.
- Support the initiative visibly
- Use digitally provided product information in future
- Anchor the standard in your own supply and procurement terms
The power to shape it: you set the pace and move the industry to abandon analogue channels – an advantage no single hospital can achieve on its own.
For MedTech manufacturers
You actively shape the standard – and lay the foundation for digital service and business processes.
- Describe & establish AAS submodels for medical technology
- Contribute declarations of intent & resources from the industry associations
- Work together on an interoperable standard
- Take the lead: shape the market instead of following a standard set later
Getting started is easy: standardised submodels – digital nameplate, technical data, handover documentation, maintenance, carbon footprint – already exist. We deliberately keep the barrier to entry low and support you along the way.
Initiators & innovation partners
The first manufacturers are already driving the solution forward. More healthcare providers and medical device manufacturers are joining as innovation partners.
Become an innovation partner of the MedTech Safety Hub
Shape it actively and support the initiative. Appear – after agreement – by name and with your logo. Providers use the digital information, manufacturers actively shape the standard.