BVLOS approval for medical drones in Germany: SORA, LUC and the path to routine operation

Medical drone logistics in Germany runs on a fully European legal basis. Commission Implementing Regulation (EU) 2019/947 governs the operation, and Delegated Regulation (EU) 2019/945 governs the aircraft and its components. Together they define three operational categories that follow the risk of the flight rather than the weight class of the aircraft: open, specific and certified.

• Open category: low-risk flights within visual line of sight. Structurally unsuitable for BVLOS medical logistics, regardless of how light the aircraft is.
• Specific category: medium-risk operations, including BVLOS. Requires an operational authorisation, a standard scenario declaration, or an operator certificate.
• Certified category: operations comparable to manned commercial aviation, for example carrying people.

Routine BVLOS transport of laboratory samples, blood products or pharmaceuticals between clinical sites therefore sits squarely in the specific category. That category is not a single permission but a set of evidence pathways, and which one is open to a given project is decided by the route, not by the drone.

One point deserves clarity before any of the detail. wedrone, the drone unit of werob, does not fly and holds no aviation certificates of its own. The operating permission is always held by an approved partner operator. What wedrone structures is everything around it: route and payload requirements, the technical specification, the interfaces to laboratory and hospital processes, and the selection of an operator whose existing approval profile actually fits the intended route. The clinical side of that work is set out under medical drone logistics.

Within the specific category, European aviation law offers four routes to a lawful BVLOS operation. For a hospital-to-laboratory route, three of them tend to close quickly.

• Standard scenarios (STS): STS-01 covers VLOS operations over a controlled ground area. STS-02 covers BVLOS operations over a controlled ground area in a sparsely populated environment, with airspace observers. Both rest on a controlled ground area, which cannot realistically be maintained along an urban transit corridor.
• Pre-defined risk assessments (PDRA): templates in which EASA has pre-solved the risk assessment for a recurring operational pattern, provided the operation stays inside rigid boundaries.
• Individual operational authorisation: a full SORA for the specific route, submitted to the national authority.
• Light UAS Operator Certificate (LUC): an organisational certificate that lets a mature operator authorise its own operations within a defined scope.

The decisive point is the PDRA question, and it is routinely reported wrongly. There is to date no PDRA for BVLOS operations over populated areas. The published inventory remains unchanged: PDRA-S01, PDRA-S02, PDRA-G01, PDRA-G02 and PDRA-G03. PDRA-05 through PDRA-08 are still in development. Any consultancy promising a template shortcut for a city route is describing a document that does not exist.

The practical consequence is straightforward. A clinic route across a built-up conurbation requires the full individual SORA assessment, and it typically lands at SAIL III or SAIL IV. That is not a formality. It is the level at which technical integrity, procedures and organisational maturity all have to be demonstrated rather than asserted.

The Specific Operations Risk Assessment was developed by the Joint Authorities for Rulemaking on Unmanned Systems (JARUS). Since 29 September 2025, version 2.5 has been the binding Acceptable Means of Compliance, adopted by EASA through ED Decision 2025/018/R. Anyone still preparing a dossier against SORA 2.0 material is working to a superseded methodology, and a great deal of the guidance still circulating online describes exactly that.

Three changes matter for a medical route.

• The intrinsic ground risk class is now quantitative. The former lookup logic has been replaced by a model that derives the iGRC from the population density under the operational volume together with the aircraft's characteristic dimension and impact energy. Population data becomes evidence, and it has to be defensible.
• The CONOPS document is gone. It has been replaced by Detailed Operational Information, a structured description of the operation with defined content rather than a free-form narrative. In practice this raises the bar on the operational description early in the process.
• The assessment is structured in ten steps, running from the operational description through the ground risk track, the air risk track, the determination of the SAIL, the assignment of the operational safety objectives, the adjacent area and airspace considerations, and finally the comprehensive safety portfolio.

For a hospital, the practical reading of SORA 2.5 is that the route is the object of assessment, not the aircraft. Change the corridor, the landing site or the payload class, and parts of the assessment have to be revisited. That is why route definition belongs at the start of a project, not after the hardware decision. The same logic applies to the operational side of a lab route, covered in our article on cutting lab transport times with drones.

The ground risk track asks a single question: what happens to people on the ground if the aircraft comes down. Under SORA 2.5 the intrinsic ground risk class is derived quantitatively from the population density beneath the operational volume, the characteristic dimension of the aircraft and its impact energy. A clinic route in a conurbation starts high, because the population density along the corridor is exactly what makes the route useful in the first place.

Reducing the ground risk class

Two families of mitigation are available, and both have to be substantiated at a level of robustness matching the target SAIL.

• Strategic mitigation (M1): reducing the number of people at risk through route geometry, corridor selection, time-of-day restrictions and a horizontal ground risk buffer that keeps the credible impact footprint away from crowded areas.
• Impact reduction (M2): technical measures that reduce the effect of an impact, most commonly a parachute recovery system. The credit granted depends on the demonstrated reliability and effectiveness of the system, not on its mere presence on the airframe.

Two points are worth stating plainly, because they are where projects lose time. First, mitigation credit has to be earned with evidence, and a datasheet claim is not evidence. Second, the ground risk buffer is a planning constraint, not a formality: it often determines where a landing site can physically go on a hospital campus, which is why the site question and the approval question have to be worked in parallel.

The air risk track assesses the rate at which the drone might encounter manned aircraft. The air risk class runs from ARC-a, atypical or shielded airspace with a negligible encounter rate, through ARC-b and ARC-c to ARC-d, the controlled airspace around major airports. A German clinic route rarely stays in one class along its whole length: helicopter traffic to the hospital's own helipad, air rescue corridors, and control zones around regional airports all shape the picture.

Where the initial class is too high, operators apply strategic mitigation through airspace design and operational restrictions, and tactical mitigation through electronic conspicuity and detect-and-avoid provisions. Transponder and cooperative surveillance equipment, geofencing and defined contingency procedures are the standard toolkit. The lower the residual air risk, the lower the resulting SAIL, and the lower the assurance burden across the whole dossier.

U-space exists in law, barely in practice

The regulatory answer to dense low-level traffic is U-space: Regulation (EU) 2021/664 sets the framework, complemented by (EU) 2021/665 and (EU) 2021/666, applicable since 26 January 2023. Implementation has been slow. San Salvo in the Abruzzo region is the first and so far only fully certified operational U-space airspace in the European Union, in place since 1 January 2026, covering some 307 square kilometres. Across the Union only a handful of service providers are certified.

Since 15 July 2026 EASA has been consulting on a lighter category, U-space Light, under NPA 2026-103. It is a consultation document. It is not applicable law, and no project plan should assume it. For the foreseeable future, German clinic routes are approved as individual operations in conventional airspace, coordinated with the airspace users around them, not inside a managed U-space volume.

Combining the final ground risk class with the residual air risk class yields the Specific Assurance and Integrity Level, SAIL I to VI. The SAIL is the pivot of the whole method: it determines which operational safety objectives apply and at what robustness, covering technical design, procedures, crew competence, maintenance, and the organisation behind the operation.

Both German routes in routine medical operation today were approved at SAIL III. That is the realistic target for a clinic project, and it sets the standard for the technical documentation, the operator's management system and the interfaces on the hospital side.

This is where the division of roles has to be explicit. wedrone does not fly, does not hold aviation certificates, and does not obtain approvals. The authorisation is applied for and held by the partner operator. What wedrone contributes is the structuring work around it: translating clinical requirements into a route and payload specification, comparing operators against the profile of the intended route, and defining the interfaces to laboratory logistics, sample handling and hospital IT. Ground-based transport inside the building is a separate question, addressed in our healthcare robotics overview.

The Light UAS Operator Certificate under Part C of the Annex to Regulation (EU) 2019/947 is the highest level of organisational trust in the specific category. Rather than approving a single operation, the authority approves the operator's ability to assess and authorise its own operations within a defined scope. For a hospital planning a network of routes rather than a single corridor, an operator holding a LUC is a meaningful advantage, because new routes within the certified scope no longer require a separate application for every case.

In Germany the Luftfahrt-Bundesamt is the competent authority for both individual operational authorisations and the LUC. The requirements are organisational, not technical, and that is precisely why they are demanding.

• A functioning safety management system with independent safety and compliance monitoring.
• Documented operational concepts, emergency response plans and continuous crew training.
• Ongoing oversight and audits by the authority to verify that the organisation still matches its certificate.
• Formal internal procedures for risk assessment, in effect an in-house SORA capability.

LUC holders remain rare in Germany. For hospitals this is less a problem than a selection criterion: the practical question in procurement is not whether the hospital can obtain permissions, because it cannot and should not try, but whether the operator's existing certificate scope covers the intended route, and what happens to the route if that operator withdraws from the market.

A permit is not a business case. Across the European Union there are 496 active BVLOS authorisations in 11 member states, and only 89 of them are considered economically viable. That ratio is the single most useful number in this field: the regulatory pathway is passable, but most of the operations that pass through it do not carry themselves. For a hospital this argues for routes with genuine daily volume and a clear clinical trigger, not for a demonstrator.

The second bottleneck sits entirely outside aviation law. Municipal building and planning law decides whether a landing site, its enclosure and its access can be built at all. The most instructive European example is Manna in Ireland, where the aviation authority had granted the operational permissions and local councils then refused planning consent for the hubs. A landing site on a hospital campus touches building law, fire safety, hospital hygiene zoning and neighbours. That process runs on its own timeline and has to start early, in parallel with the aviation dossier rather than after it.

Zollernalb Klinikum: what a completed pathway looks like

The clearest German reference is Zollernalb Klinikum with the operator DiAvEn and its Labfly system, connecting the Albstadt and Balingen sites over roughly 20 kilometres with laboratory samples and blood products. The LBA authorisation was granted in August 2024 at SAIL III, including dangerous goods UN 3373. Test operations began in October 2024 and the route moved into routine operation in 2025, with around seven flights per day, seven days a week. The reported transport cost is 75,000 euros per year, against 180,000 to 220,000 euros for the previous arrangement.

Two details matter more than the headline. The route was approved as an individual SORA case, not through a template, and the dangerous goods classification for Category B biological substances under UN 3373 with packing instruction P650 was part of the package from the start. A second German route, operated by Jedsy for Asklepios and MEDILYS in Schleswig-Holstein, has been running scheduled since March 2025, also at SAIL III. A wider view of what is actually flying in Europe is collected in our survey of medical drone transport.

One frequent source of confusion is worth closing off. The United States rule often cited as the coming BVLOS regime, FAA Part 108, is not in force. It exists as proposed rulemaking. Nothing in a German approval strategy should be built on it.