Welcome to this fortnight's SMEDTEC Intelligence. Regulatory activity has been brisk across both sides of the Atlantic. FDA has issued a final reclassification order for in situ hybridisation oncology companion diagnostics (effective 16 September) and is consulting on two further downclassifications — digital breast tomosynthesis and cystoscopic systems — plus a broad class I accessory list. In the UK, MHRA has issued an immediate 'quarantine' directive for devices supplied without valid UKCA/CE markings, published a safety ban on infant rectal catheters, and opened a statutory-fees consultation that will directly affect budgets across the sector. We've also flagged the FDA's TEMPO digital health pilot expansion and the ResMed ventilator National Patient Safety Alert for those managing life-critical portfolios. Read on for the details that matter.
FDA Final Order: ISH Oncology Companion Diagnostics Reclassified Class III → Class II (Effective 16 September 2026)
FDA · US
This final order reclassifies in situ hybridisation (ISH) test systems intended for use with approved oncology therapeutics (product codes NYQ, MVD, OWE, PNK) from Class III (PMA) to Class II (special controls + 510(k)). Manufacturers of these companion diagnostics must review the new classification regulation and special controls immediately — existing PMA holders should assess transition obligations before the 16 September effective date, and pipeline 510(k) applicants should align their technical files to the newly codified special controls.
Read the source →MHRA Issues Immediate Quarantine Directive for Devices Lacking Valid UKCA/CE Markings (DSI/2026/007)
MHRA · UK
MHRA has identified multiple devices on the UK market that do not comply with UK MDR 2002 or EU MDR/IVDR conformity requirements. The directive instructs healthcare organisations to remove non-conforming devices from use and place them in quarantine. For manufacturers, importers and distributors, this is a sharp reminder to audit supply chains and ensure all UK-placed devices carry current, valid UKCA or CE marking backed by subsisting certification. Non-compliance now carries an imminent risk of product seizure and reputational damage.
Read the source →MHRA Safety Ban: Do Not Use Rectal Catheters (Gas & Colic Relievers) in Infants (DSI/2026/008)
MHRA · UK
MHRA has issued a 'Do Not Use' directive for all rectal catheters marketed as gas and colic relievers in infants. Manufacturers and distributors of these products must act immediately — stop supply, initiate a field safety corrective action if devices are already in circulation, and review any related product portfolio for compliance. This signals heightened MHRA scrutiny of paediatric-use devices and associated marketing claims.
Read the source →FDA Proposed Rule: Class I Classification for Broad List of Device Accessories (Comment Period Open)
FDA · US
Under FDARA 2017 requirements, FDA is proposing to classify a list of accessories as Class I (general controls only) and as distinct devices in their own right. This is significant for any manufacturer whose accessories are currently regulated under a parent device classification — a shift to standalone Class I status changes submission requirements, labelling obligations and QMS scope. Affected companies should review the proposed list carefully, assess their accessory portfolio, and submit comments during the open docket period.
Read the source →FDA Proposed Reclassification: Digital Breast Tomosynthesis (DBT) Systems Class III → Class II
FDA · US
FDA is proposing to downclassify DBT systems (product code OTE) from PMA-required Class III to Class II with special controls and 510(k). This is a major market-access opportunity for DBT manufacturers: if finalised, new entrants can pursue 510(k) rather than the more burdensome PMA pathway. Existing PMA holders should monitor the proposal and consider how the new special controls framework will affect post-market commitments. Public comments should be submitted before the docket closes.
Read the source →FDA Proposed Reclassification: Cystoscopic Systems for Bladder Cancer Detection Class III → Class II
FDA · US
FDA proposes to reclassify diagnostic endoscopic light source systems (product code OAY) — rebranded as 'Cystoscopic systems intended as an aid for detection of bladder cancer' — from Class III (PMA) to Class II (special controls + 510(k)). Manufacturers in the urology/endoscopy space should review the proposed special controls, evaluate whether their existing or pipeline devices fall under the new product definition, and engage in the comment process to help shape the final regulatory requirements.
Read the source →MHRA Consultation on Statutory Fees 2026: Budget Impact for All UK Applicants
MHRA · UK
MHRA has opened a formal consultation on revised statutory fees aimed at cost recovery and funding enhanced regulatory services. Fee changes will affect pre-submission meetings, conformity assessment applications, clinical investigation approvals, and post-market surveillance interactions. Regulatory-affairs leaders at SMEs should model the potential cost impact now, contribute to the consultation to represent smaller manufacturers' interests, and update multi-year regulatory budgets accordingly.
Read the source →National Patient Safety Alert: ResMed Astral 100 & 150 Ventilators — Risk of Unexpected Ventilation Interruption (NatPSA/2026/004/MHRA)
MHRA · UK
MHRA has issued a National Patient Safety Alert — the highest-urgency tier in the UK post-market safety system — regarding a fault in ResMed Astral 100 and 150 ventilators and associated PCBAs manufactured before October 2024 that can cause unexpected interruption of life-sustaining ventilation. Manufacturers of life-critical respiratory devices should treat this as a benchmark case for FSCA planning and vigilance reporting obligations. Healthcare providers using these devices must implement the corrective actions detailed in the Field Safety Notice without delay.
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