The week of 7–13 September 2026 brought several relevant regulatory updates in the medical device and in vitro diagnostic (IVD) sectors.
The main developments included revised MDCG guidance on IVDR classification rules, UK recommendations for the future regulation of AI in healthcare, a new Swissmedic guideline on IVD materiovigilance, an FDA final order covering cardiovascular machine-learning software, and a Class I recall involving hospital glucose and ketone meters.
In this issue
- MDCG updates guidance on IVDR classification rules
- UK National Commission presents recommendations for the regulation of AI in healthcare
- Swissmedic publishes GPMV-IVD guideline on IVD materiovigilance
- FDA codifies Class II classification for cardiovascular machine learning-based notification software
- FDA posts Class I recall for Nova Biomedical StatStrip glucose and ketone meter
MDCG updates guidance on IVDR classification rules
On 9 September 2026, the European Commission published MDCG 2020-16 Rev.5, the latest revision of the guidance on classification rules for in vitro diagnostic medical devices under the IVDR.
Revision 5 updates Rule 7, clarifying the rationale and examples for controls without quantitative or qualitative assigned values.
The guidance states that standalone quality-control materials may include manufacturer-indicated analyte ranges without those values necessarily constituting “assigned values”, where the target values routinely used are determined by the medical laboratory.
Unless another classification rule applies, these controls fall under Class B.
Controls with quantitative or qualitative values assigned by the manufacturer, including assay-kit validity controls, remain subject to the classification approach set out in section 1.6 of the guidance.
The guidance also clarifies that standalone quality-control materials under Rule 7 are intended to monitor the validity of laboratory examination procedures and cannot replace mandatory control materials used to verify the performance of the IVD itself.
As with other MDCG documents, the guidance is non-binding and does not represent an official European Commission position.
The revision provides additional clarification on the IVDR classification of standalone IVD quality-control materials.
Related resource: the IVDR Classification Rules guide has also been updated to reflect MDCG 2020-16 Rev.5.
Source: MDCG
Reference: MDCG 2020-16 Rev.5 — Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746, MDCG
UK National Commission presents recommendations for the regulation of AI in healthcare
On 10 September 2026, the National Commission into the Regulation of AI in Healthcare published its recommendations for a future UK regulatory framework covering AI in healthcare, including software and AI-enabled medical devices.
Commission recommends a more proportionate and lifecycle-based approach to the regulation of healthcare AI.
The recommendations include staged authorisation pathways for suitable AI-enabled medical devices, greater use of real-world evidence, tailored post-market surveillance and more continuous monitoring of device performance after deployment.
The Commission was established to advise the UK Government on a future regulatory framework for AI in healthcare.
Its recommendations do not constitute adopted regulatory policy. A cross-government response will follow separately.
The report sets out a potential direction for future UK oversight of software and AI-enabled medical devices, including alternatives to single-timepoint pre-market assessment.
Source: MHRA / National Commission into the Regulation of AI in Healthcare
Reference: National Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework, MHRA / National Commission into the Regulation of AI in Healthcare
Swissmedic Publishes GPMV-IVD Guideline on IVD Materiovigilance
On 10 September 2026, Swissmedic published the new Schweizerische Gute Praxis der Materiovigilance in der In-vitro-Diagnostik, or GPMV-IVD.
The guideline is primarily intended for laboratories and professionals involved in the IVD testing process, including point-of-care testing.
It provides practical support for implementing IVD materiovigilance obligations.
Swissmedic describes the GPMV-IVD as a reference document for IVD materiovigilance.
The guideline covers, among other topics, the reporting of serious incidents, the handling of field safety notices and the implementation of field safety corrective actions involving IVDs.
The document was developed on the basis of the Swiss Ordinance on In Vitro Diagnostic Medical Devices, together with the EU IVDR framework incorporated into the Swiss regulatory context.
This publication establishes a dedicated Swiss reference framework for vigilance activities involving IVDs used in laboratories and point-of-care settings.
Source: Swissmedic
Reference: Schweizerische Gute Praxis der Materiovigilance in der In-vitro-Diagnostik, GPMV-IVD, Swissmedic
FDA Codifies Class II Classification for Cardiovascular Machine-Learning Notification Software
On 11 September 2026, FDA issued a final order codifying the Class II classification of cardiovascular machine learning-based notification software in 21 CFR 870.2380.
The underlying classification had been applicable since 3 August 2023 following a De Novo classification request.
FDA defines the device type as software using machine-learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up, based on one or more non-invasive physiological inputs.
The software is not intended to provide diagnostic-quality output or to identify or detect arrhythmias.
Class II special controls include clinical performance testing, non-clinical performance testing, software verification and validation, hazard analysis, human-factors assessment and specific labelling requirements.
The order establishes a codified U.S. regulatory category and special-control framework for this type of cardiovascular machine-learning software.
Source: FDA
Reference: Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software, FDA
FDA Posts Class I Recall for Nova Biomedical StatStrip Glucose and Ketone Meter
On 11 September 2026, FDA posted a Class I recall record covering Nova Biomedical’s StatStrip Glucose and B-Ketone meter. The manufacturer had initiated the action on 29 July 2026.
This recall concerns a software synchronisation and timing issue affecting barcode scanning and patient-data processing.
The affected meters may intermittently retain a previously scanned patient or quality-control barcode when a new barcode is scanned, leaving the previous identifier displayed for the current test.
If the mismatch is not recognised by the operator, a glucose result may be assigned to the wrong patient record and transmitted to the data management system, while the current patient’s record may not receive the result.
FDA also notes that the issue can affect quality-control barcode scanning, but does not affect the analytical accuracy of glucose measurements.
Nova has placed affected StatStrip Gen 2 systems on shipment hold while developing and validating a firmware update.
The affected products were distributed worldwide, including in several European countries such as Italy, France, Germany, Ireland, Switzerland and the United Kingdom.
The Class I action involves hospital near-patient glucose testing and a software issue affecting patient and quality-control identification.
Source: FDA / CDRH
Reference: Class 1 Device Recall — StatStrip Glucose and Ketone Hospital Meter System, FDA
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