This special summer edition of MDN covers the main regulatory developments published in August 2026 in the medical device and in vitro diagnostic (IVD) sectors.
The month brought new essential principles for Predetermined Change Control Plans, revised FDA guidance on human factors and usability engineering, a Team-NB position paper on transparency in the proposed MDR and IVDR revision, changes to the U.S. classification of certain oncology IVDs, an FDA discussion paper on generative AI-enabled medical devices, and several other regulatory, vigilance, market-surveillance and standards updates.
In this issue
- IMDRF publishes essential principles for Predetermined Change Control Plans
- FDA updates human factors and usability engineering guidance
- Team-NB publishes a position paper on transparency in the context of the proposed revision of the MDR and IVDR Regulations
- MHRA issues notice over devices supplied without valid UKCA or CE markings
- FDA reclassifies certain oncology-related ISH test systems to Class II
- FDA opens discussion on regulation of generative AI-enabled medical devices
- EMA updates consultation procedure for ancillary medicinal substances in medical devices
- FDA publishes Recognition List 066 for consensus standards
- ISO publishes updated ISO 10993-3
- MHRA highlights metal-wear risks in cobalt-chrome modular-neck hip replacements
IMDRF Publishes Essential Principles for Predetermined Change Control Plans
On 6 August 2026, the International Medical Device Regulators Forum published Essential Principles and Content of Predetermined Change Control Plans.
The document sets out internationally developed principles for Predetermined Change Control Plans, or PCCPs, applicable to medical device software. A PCCP describes specified future software changes, the protocol and predefined criteria for implementing and controlling those changes, and an assessment of their potential impact.
The framework is intended for certain modifications that, without a PCCP, could require regulatory authorisation before implementation, provided that they remain within the device’s original intended use or intended purpose.
Implementation and acceptance of PCCPs remain subject to individual regulatory jurisdictions.
The document provides a common international reference for regulatory approaches to planned modifications of medical device software.
Source: IMDRF
Reference: Essential Principles and Content of Predetermined Change Control Plans — IMDRF/SaMD WG/N90 FINAL:2026, IMDRF
FDA Updates Human Factors and Usability Engineering Guidance
On 3 August 2026, FDA published an updated version of Applying Human Factors and Usability Engineering to Medical Devices, originally published in 2016.
The guidance addresses the application of human factors and usability engineering during medical-device development, with particular focus on reducing use-related hazards associated with the user interface.
According to FDA, the August revision updates definitions and the documentation section to align with the 2026 final guidance on the content of human-factors information in medical device marketing submissions.
The document also reflects the Quality Management System Regulation, which took effect in February 2026.
The update concerns one of FDA’s principal reference documents for human factors, usability engineering and management of use-related risks in medical devices.
Source: FDA / CDRH
Reference: Applying Human Factors and Usability Engineering to Medical Devices, FDA
Team-NB Publishes a Position Paper on Transparency in the Context of the Proposed Revision of the MDR and IVDR Regulations
On 6 August 2026, Team-NB published a position paper on transparency in the context of the proposed revision of the MDR and IVDR Regulations.
The association argues that proportionate and risk-based surveillance requires notified bodies to have access to broader information on the European Union market, including information on vigilance, field safety corrective actions, field safety notices, clinical investigations and performance studies involving comparable devices.
Team-NB notes that such information should not be limited primarily to the certification portfolios of individual notified bodies.
The document proposes broader notified-body access to EUDAMED and other relevant electronic regulatory systems, together with confidentiality safeguards.
Position paper represents the view of the European association of notified bodies for medical devices and does not constitute an EU regulatory act or a European Commission position.
The document sets out the notified-body sector’s position on how access to EUDAMED data could support the risk-adaptive surveillance model considered in the context of the proposed MDR/IVDR revision.
Source: Team-NB
Reference: Transparency, Team-NB
MHRA Issues Notice over Devices Supplied without Valid UKCA or CE Markings
On 10 August 2026, MHRA issued Device Safety Information DSI/2026/007 concerning a number of medical devices supplied on the UK market without valid UKCA or CE conformity markings or supporting certification.
The affected products cover several clinical areas, including blood collection and infusion, surgical and biopsy procedures, wound management and skin preparation.
MHRA stated that it had not identified a specific defect, performance issue or safety signal associated with the products. However, in the absence of valid conformity assessment and supporting certification, the safety, sterility, performance and quality systems of the devices could not be fully assured.
The Agency requested that the identified products be removed from use and supply and placed in quarantine while the investigation continues.
The notice represents a market-surveillance action affecting multiple device categories on the UK market, rather than an isolated product recall.
Source: MHRA
Reference: Devices supplied without valid UKCA/CE conformity markings or certification: remove from use and place in quarantine, DSI/2026/007, MHRA
FDA Reclassifies Certain Oncology-Related ISH Test Systems to Class II
On 17 August 2026, FDA published a final order reclassifying certain in situ hybridization test systems intended for use with corresponding approved oncology therapeutic products from Class III to Class II with special controls.
The affected prescription IVDs, identified under product codes NYQ, MVD, OWE and PNK, will be subject to the 510(k) premarket notification pathway rather than PMA requirements for new devices of these types.
Special controls cover areas including risk mitigation, result interpretation, analytical sensitivity and specificity, precision and reproducibility, robustness, clinical performance and labelling.
The order becomes effective on 16 September 2026. Devices with existing PMA approvals may continue to be marketed under their previous authorisations, subject to the implementation provisions described by FDA.
The order changes the regulatory classification and premarket pathway for a defined group of prescription oncology-related IVDs.
Source: FDA
Reference: Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product, FDA
FDA Opens Discussion on Regulation of Generative AI-Enabled Medical Devices
On 18 August 2026, FDA published Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback.
The document explores regulatory considerations for generative AI-enabled medical devices, including risk assessment, premarket evaluation and postmarket monitoring, and requests input from manufacturers, clinicians, researchers and other stakeholders.
FDA emphasises that the document is intended for discussion purposes only. It is neither draft nor final guidance, does not establish regulatory expectations and is not intended to propose or implement changes to CDRH policy.
Feedback is requested by 19 October 2026.
The paper provides an early indication of the regulatory questions FDA is examining as generative AI capabilities are incorporated into medical devices.
Source: FDA / CDRH
Reference: Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback, FDA
EMA updates consultation procedure for ancillary medicinal substances in medical devices
On 18 August, EMA published Revision 4 of its Q&A on the consultation procedure for medical devices incorporating an ancillary medicinal substance or an ancillary human blood derivative.
The August revision updates the procedure for submitting a letter of intent for an initial consultation. Applicants are now directed to use the IRIS platform and to notify EMA at least six months before the expected submission date. The request should be submitted at least 10 days before a CHMP meeting to support timely inclusion on the agenda.
Following submission of the letter of intent, EMA assigns a Unique Product Identifier (UPI), which should be used for subsequent correspondence with the Agency.
The revision updates the entry point for notified-body consultations with EMA involving medical devices that incorporate certain ancillary medicinal substances or human blood derivatives.
FDA Publishes Recognition List 066 for Consensus Standards
On 24 August 2026, FDA published Recognition List 066, introducing modifications to the list of consensus standards recognised for use in medical-device premarket reviews.
The notice updates FDA-recognised consensus standards across several technical areas. FDA-recognised standards may be used to support parts of medical-device premarket submissions, including through declarations of conformity where applicable.
Among the standards affected are several documents with broad relevance for medical devices, including updates in the ISO 10993 biological evaluation series and IEC 60601 standards for medical electrical equipment.
The modifications are applicable from 24 August 2026.
Recognition List 066 updates the set of consensus standards that may be referenced in FDA medical-device submissions.
Source: FDA / CDRH
Reference: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066, FDA
ISO Publishes Updated ISO 10993-3
On 6 August 2026, ISO published ISO 10993-3:2026, Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity.
This fourth edition cancels and replaces ISO 10993-3:2014 and ISO/TR 10993-33:2015.
The standard has been extensively revised, with greater emphasis on evaluation rather than testing alone and increased use of chemical characterisation and toxicological risk assessment.
The standard addresses the assessment of genotoxic, carcinogenic, reproductive and developmental toxicity risks as part of the biological evaluation of medical devices.
ISO 10993-3 is a key part of the ISO 10993 biological-evaluation framework, and the 2026 edition substantially updates the approach to evaluating genotoxicity, carcinogenicity and reproductive and developmental toxicity risks.
Source: ISO
Reference: ISO 10993-3:2026 — Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity, ISO
MHRA Highlights Metal-Wear Risks in Cobalt-Chrome Modular-Neck Hip Replacements
On 26 August 2026, MHRA issued Device Safety Information DSI/2026/010 following an investigation into cobalt-chrome dual taper modular-neck hip replacements previously available on the UK market.
The review identified potential increased risks of wear and corrosion associated with the additional interfaces in these designs, including a possible increased occurrence of revision surgery due to adverse local tissue reaction.
All of the implant systems covered by the review had been removed from the UK market before 2019 and none remain commercially available.
MHRA recommends that patients implanted with affected devices be identified and invited for clinical review.
UK National Joint Registry data showed variation between implant systems. The SPS modular system had a revision rate due to adverse local tissue reaction approximately twice that expected, while no system investigated showed a higher-than-expected revision rate due to device fracture.
The communication introduces follow-up recommendations for patients implanted with several legacy cobalt-chrome modular-neck hip systems that are no longer commercially available.
Source: MHRA
Reference: Cobalt-chrome modular neck hip replacements: risk of metal-wear effects and revision surgery, DSI/2026/010, MHRA
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