Is Surgical Planning Software MDR Class IIa?
What the EU device database shows about how orthopaedic planning software is classified under MDR Rule 11, including a notified body certificate issued in June 2026.
Key takeaways
Under the EU Medical Device Regulation, planning software is classified by Rule 11, and the question that decides everything is what the information is used for and what happens if it is wrong. Reading the rule alone leaves genuine room for argument between Class IIa and Class IIb. Reading the public EU device database narrows it considerably: as of a September 2026 search, every musculoskeletal planning package registered there is Class IIa, and every planner registered as Class IIb is either radiotherapy dose or neurological and spinal trajectory. There is also a notified body certificate issued in June 2026 for orthopaedic planning software at Class IIa. That does not settle any individual case, which is decided with a notified body, but it means the IIa position is an evidenced starting point rather than a hopeful one.
What Rule 11 actually asks
Rule 11 of Annex VIII to Regulation (EU) 2017/745 covers software intended to provide information used to take decisions for diagnostic or therapeutic purposes. Such software is Class IIa, and it moves up if the consequences of a wrong decision are more severe: Class III where a decision could cause death or an irreversible deterioration of health, Class IIb where it could cause a serious deterioration of health or a surgical intervention.
The debate for orthopaedic planning software lives in one phrase. If a wrong plan "may cause a surgical intervention", does that make every planner Class IIb, given that the patient is already going to surgery? Two readings exist, and the argument gets circular fast, which is why the register is more useful than the rule text.
What the register shows
A search of the public EUDAMED device registry for planning software, run on 7 September 2026, returned 80 registered devices:
| MDR class | Devices | What they are |
|---|---|---|
| Class I | 53 | Viewers, image handling, non-decision-supporting tools |
| Class IIa | 8 | Musculoskeletal and orthopaedic surgical planning |
| Class IIb | 19 | Radiotherapy and brachytherapy dose, neurological and spinal trajectory, cardiac planning |
The split is not arbitrary. Every Class IIb planner in that set plans something that is delivered to the patient directly by the plan itself: a radiation dose, or a trajectory into the brain or spine. Examples registered at Class IIb include Brainlab Spine Planning, Varian Eclipse, BEBIG SagiPlan, Renishaw neuroinspire and Siemens syngo.CT Cardiac Planning.
The musculoskeletal planners sit at Class IIa, including ONE ORTHO's 3D Knee, 3D Hip and 2D Hip planning software, Materialise SurgiCase Knee Planner, Blue Ortho GPS Shoulder Planning and Navbit Rapid Surgical Plan.
One registration is worth quoting in full, because it is the most checkable:
ONE ORTHO, "3D Knee Planning Software". Manufacturer SRN FR-MF-000018482 · Basic UDI-DI
37015089_KNEE_PLANNERPD· Primary DI03760345350068· Class IIa · on the market.
Anyone can put that Basic UDI-DI into the public EUDAMED search and see the class for themselves. That is the reason to cite a register rather than an opinion.
The certificate that matters most
Database entries are submitted by manufacturers. A notified body certificate is a third party's decision, which makes it stronger evidence.
In June 2026, TÜV SÜD Danmark ApS (notified body 2443) issued a certificate under Annex IX of the MDR for orthopaedic surgical planning software, at Class IIa, under code MDA 0315 (medical device software), valid 11 June 2026 to 10 June 2031. The certificate holder is a Swiss developer of software-only fracture planning.
So a notified body, in 2026, assessed an orthopaedic planning package and certified it at IIa. For anyone preparing a classification rationale, that converts "defensible but untested" into "defensible, with a recent precedent a reviewer can verify".
What this does and does not settle
It does not settle your device. Classification depends on the intended purpose you write, not on what a similar product did. Two planners with identical code and different intended-purpose statements can land in different classes, and the manufacturer carries that decision.
Four practical consequences:
- The intended purpose is the regulatory object, not the algorithm. "Provides measurements and a proposed plan for the surgeon to review and approve" and "determines the resection" are different devices in law, whatever the software does.
- Rule 11 is not the only rule to check. Annex VIII contains implementing rules that can pull a device up, and accessory status matters if the software is placed on the market as part of another device.
- A register precedent is evidence, not authority. Cite it to open the conversation with a notified body, not to close it.
- Class IIa still requires a notified body. It is a lighter route than IIb, not a self-certification route. Quality system, clinical evaluation, technical documentation, UDI assignment and EUDAMED registration all apply, and actor and device registration obligations have been phasing in through 2026.
Why this question decides commercial structure too
For an implant manufacturer weighing whether to license planning software, class is not a compliance detail, it is the timeline and the budget. Class IIa with a notified body is a route that a mid-size manufacturer can plan around. Class IIb changes the conformity assessment burden and the clinical evidence expectation, and it changes who can realistically carry it.
It also interacts with how the deal is structured, because the party that holds the intended purpose holds the regulatory obligation. In a white-label arrangement, that question has to be answered in the contract before either side builds anything, alongside IP and field-of-use and the payment structure itself, which we set out in the manufacturer-pays model for planning.
Where Salnus sits
Our software is Research Use Only today. It is not CE marked and not FDA cleared, and we say that in every conversation before commercial terms come up. The regulatory route we are working toward is MDR Class IIa, with the intended purpose written as decision support that a surgeon reviews and approves, which is the position the register above supports. The evidence work that route requires is the same work described in measurement reproducibility, which is why we treat the two as one programme rather than two.
None of this is regulatory or legal advice. Classification is a decision for the manufacturer with its notified body, on the basis of a specific intended purpose.
Bottom line
MDR Rule 11 leaves room to argue, but the EU register does not leave much: musculoskeletal planning software is registered at Class IIa, Class IIb is occupied by dose and trajectory planning, and a notified body certified an orthopaedic planner at IIa in June 2026. Write the intended purpose first, check it against the register, and take the precedent to your notified body rather than to a customer. For the wider picture of what is cleared, marked and merely claimed across the field, see the 2026 comparison of orthopedic 3D planning software and the regulatory pathway for licensed planning software.
Reviewed by the Salnus biomedical engineering team.