Abstract
<jats:p>Background: In August 2025, an analysis of nearly 128,000 apps on the Google Play Store identified 95,731 as qualifying Software as a Medical Device (SaMD), of which 95% lacked verifiable evidence of CE marking (EU MDR) or FDA authorization in their public listings (Wagner, 2025, DOI 10.70317/2025.08rw01). At the time of publication, no explicit regulatory guidance addressed the legal responsibilities of app platform providers with respect to SaMD. Objective: To conduct a re-analysis of SaMD compliance in the Google Play Store ten months after the publication of MDCG Guidance 2025-4 (June 2025), which explicitly addresses the roles of app platform providers as distributors and importers under Articles 13 and 14 of the EU Medical Device Regulation (MDR). The re-analysis maps the empirical findings against MDCG 2025-4 obligations. Method: A dataset of 45,604 apps qualifying as SaMD was analyzed. Classification followed the framework established in the August 2025 publication (MDCG 2019-11 rev1 and IMDRF SaMD N12/N23 guidelines), applied to a July 2026 snapshot. Each SaMD identification was mapped against three MDCG 2025-4 categories: (a) app platform placement on the market (Section 3), (b) distributor obligations under Article 14 MDR (Section 3.2), and (c) importer obligations under Article 13 MDR where manufacturer is non-EU. Pre-publication compliance requirements per Section 4.3 (referencing Article 31 DSA) were assessed. Compliance was determined based on presence of verifiable regulatory registration in the public listing. Results: Of 45,604 SaMD identifications, 45,082 (98.86%) lacked verifiable evidence of CE marking or FDA authorization — a marked increase from the 95% non-compliance rate reported in August 2025. Class-differentiated analysis revealed: Class I 98.93% non-compliant, Class IIa 98.21%, Class IIb 100.00%, Class III 94.39%. All 45,082 non-compliant SaMD implicate Google (as EU-established app platform provider) as distributor under Article 14 MDR per MDCG 2025-4 Section 3.2. Importer obligation (Category C, Article 13 MDR) mapping is deferred to a follow-up publication pending developer domicile enrichment. The Google Play Console Health Declaration workflow at the time of analysis (July 2026) contains no structured fields for capture of the required Article 14 MDR information prior to app publication. Conclusion: Ten months after the publication of MDCG 2025-4 and thirteen months after the original August 2025 analysis, the SaMD compliance gap on the Google Play Store has widened, not closed. The legal framework to address this gap has existed since June 2025. Enforcement has not followed. The gap between guidance and enforcement is now the operative question for European competent authorities. Keywords: SaMD, MDR, MDCG 2025-4, app store, distributor, importer, regulatory enforcement, medical device software, Google Play Store</jats:p>