IVDR Class A, B, C, and D: What Each Class Means for Your IVD Startup
A startup guide to the four IVDR risk classes. Class A, B, C, and D explained with conformity routes, notified body involvement, and founder implications.
Category
Digital Health, DiGA & Health IT
9 in-depth guides in this cluster
IVDR Classification Rules: How to Classify Your In Vitro Diagnostic Device
A startup walk-through of the IVDR classification rules in Annex VIII. Rule-by-rule logic, worked examples, and how to produce a defensible classification.
Companion Diagnostics Under IVDR: Regulatory Path for CDx Startups
A startup guide to companion diagnostics under IVDR. Classification, EMA consultation, performance evaluation, and the regulatory path for CDx devices.
What Is a DiGA? Germany's Digital Health Application Framework
A DiGA Germany digital health application is a CE-marked, BfArM-listed app reimbursed by statutory insurance. Honest primer for founders.
The DiGA Fast-Track Process: Reimbursement in Germany
The DiGA fast-track process offers provisional BfArM listing with later permanent listing. Honest look at evidence, timelines, and pitfalls.
DiGA Requirements 2026: Technical, Data Protection, Interoperability
DiGA requirements 2026 cover CE mark, GDPR, FHIR interoperability, and information security on top of MDR. Honest technical primer for founders.
Telehealth and Remote Monitoring Devices Under MDR
When telehealth and remote monitoring systems become medical devices under MDR, how Rules 10 and 11 classify them, and what cybersecurity MDR expects.
Health Apps That Are Not Medical Devices: The Wellness Safe Harbor
How the MDR intended-purpose test separates wellness apps from medical device software, with MDCG 2019-11 Rev.1 examples and line-crossing scenarios.
Clinical Decision Support Systems Under MDR: Qualification Criteria
How CDSS products are qualified under MDR Article 2(1), classified under Annex VIII Rule 11, and screened through the MDCG 2019-11 Rev.1 four-step flow.