Tandem supports the major European diagnosis, procedure, and billing frameworks, including ICD-10, ICD-9, ICD-11, ICPC-2, SNOMED CT, KVÅ, CCAM, OPCS-4, NKPK, EBM, GOÄ, NGAP, TARDOC, NordDRG, ISF, LOINC, QOF, and Orphacodes. ICD-10 is currently certified as a Class IIa medical device under EU MDR. Other frameworks are in active certification or supported via the platform's extensible architecture, with the right framework selected per market and clinician.

Yes. Tandem's Coding Assistant is CE marked as a Class IIa medical device under the European Medical Device Regulation (EU MDR). It's classified under Rule 11 of Annex VIII, which covers software that supports clinical decisions where the impact does not cause death, irreversible deterioration, or surgical intervention. The certification means the coding suggestion functionality has been formally evaluated against MDR requirements for clinical safety and intended use.

Before the note is signed off, Tandem flags missing supporting codes (such as an external cause code for an injury) and invalid combinations that wouldn't pass billing review. Clinicians resolve these inside Tandem during the visit, while the documentation is fresh, rather than dealing with retrospective corrections after the fact.

Tandem suggests codes; the clinician confirms them. This is by design, not a workflow limitation. Under EU MDR human oversight requirements, codes that affect the medical record and reimbursement need clinician judgment, not unverified automation. In practice, confirming a ranked, pre-validated suggestion takes a click. Reviewing pre-filled codes is faster than typing them in from scratch, and clinicians remain accountable for what enters the record.

Tandem integrates with 100+ medical record systems used across Europe, including the most common systems in Sweden, Germany, France, the UK, Spain, the Netherlands, the Nordics, and the Baltics. Once codes are confirmed, they transfer to the medical record system with one click, into the appropriate field. Custom integrations are available for regional or local requirements not covered by standard connectors.

Each market has its own canonical frameworks. Sweden uses KVÅ for procedures alongside ICD-10. France uses CIM-10 with CCAM and NGAP. Germany uses ICD-10-GM with EBM. Italy still uses ICD-9-CM. The Netherlands uses ICPC-1. The UK uses SNOMED CT and OPCS-4. Tandem adapts to the active framework in each market. Same product, right local code sets.

We recommend informing patients that you are using a tool to support documentation so you can focus fully on the consultation. We also provide information sheets that can be placed in your waiting room.