The latest regulatory updates, in one place

Global22 Oct 2026

UK confirms indefinite recognition of CE-marked medical devices and IVDs in Great Britain

The UK government has confirmed that devices and IVDs bearing a CE mark will be accepted on the British market indefinitely, following a consultation that ran from 16 February to 10 April 2026. This supersedes the earlier cut-offs of 30 June 2028 (legacy directives) and 30 June 2030 (MDR/IVDR). The UKCA route remains available, and the MHRA continues to oversee the safety of all devices on the UK market.

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UK / MHRACE mark recognitionUKCA

FDA / CDRH20 Oct 2026

FDA expands Olympus import alert to enteroscopes and capsule imaging systems

FDA updated its letter to health care providers on Import Alert 89-04, citing outstanding Quality System regulation violations at Olympus Medical Systems Corporation in Japan. The alert now also covers enteroscopes and ingestible telemetric gastrointestinal capsule imaging systems. FDA advises that devices already in use and working properly may continue to be used; the update is a reminder of how QMSR compliance can directly affect US market access.

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Import alertQuality systemMarket access

FDA / CDRH20 Oct 2026

FDA refreshes its Predetermined Change Control Plans resources and hypothetical case examples

CDRH updated its Predetermined Change Control Plan (PCCP) page and published a page of hypothetical case examples for novel devices with PCCPs, as listed in its latest news and updates. The page also tracks FDA-authorized devices that have a PCCP. Teams planning software or iterative device changes should review the examples when scoping a change-control strategy.

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PCCPChange controlCDRH guidance

EU MDR19 Oct 2026

Medtronic receives CE mark for its Vitalis portfolio of conduction system pacemakers

Medtronic announced CE marking for five Vitalis pacemakers, three of which (ReSyncra CSP, Restoria CSP and Refina CSP) offer conduction system pacing. ReSyncra CSP adds an AdaptivCSP algorithm aimed at heart failure patients who cannot achieve effective CRT through traditional approaches. The coverage does not state the devices' US regulatory status, so launch teams should treat this as an EU-only milestone for now.

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CE markPacemakersConduction system pacing

FDA / CDRH19 Oct 2026

Haemonetics announces FDA approval of PerQseal Elite vascular closure system

Haemonetics said FDA approved PerQseal Elite, a closure device using a fully absorbable patch to seal arterial access sites after large-bore structural heart and endovascular procedures. The technology came through the company's January 2026 acquisition of Vivasure Medical, and further clinical data are planned for TCT later in October. The coverage does not state the approval pathway.

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Vascular closureLarge-bore accessStructural heart

FDA / CDRH19 Oct 2026

AHA submits recommendations as FDA's generative AI device feedback window closes

The American Hospital Association detailed its comments to FDA on regulatory frameworks for generative AI-enabled medical devices, in response to the agency's August discussion paper. It supports a flexible, risk-based approach, asks FDA to refine its proposed risk heuristic, and calls for total product lifecycle alignment between premarket review and post-deployment monitoring. FDA's comment period on the discussion paper closed on 19 October.

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Generative AIRisk-based frameworkLifecycle oversight

FDA / CDRH15 Oct 2026

FDA early alert: Edwards recalls Commander M delivery systems used with Sapien M3

Edwards asked customers to remove four lots of Commander M delivery systems, used with the Sapien M3 transcatheter mitral valve, from inventory after three reports of balloon bursts during inflation. FDA's early alert says this could cause embolism or prevent device retrieval, and Edwards reported one death and one serious injury as of 5 October. Edwards says other lots are unaffected; no formal FDA recall classification is stated.

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Early alertRecallTranscatheter mitral

FDA / CDRH14 Oct 2026

CDRH publishes its FY 2027 guidance priorities, led by AI lifecycle management and PCCPs

CDRH has released its fiscal year 2027 guidance agenda. The A-list of highest-priority documents includes final guidance on AI life cycle management, predetermined change control plans, QMS information for premarket submissions, the ASCA programme and robotically assisted surgical devices; draft device software functions and post-market cybersecurity guidance sit on the B-list. No cardiovascular-specific document is listed, but the software, AI and cybersecurity items will shape submissions for connected cardiac devices. Emergo notes that CDRH has published only a share of its prior A-list documents, so timing remains indicative.

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Guidance agendaPCCPAI-enabled devices

Swissmedic09 Oct 2026

Switzerland outlines timeline for easier market access for FDA-authorised devices

Switzerland has set out its intended approach to accepting medical devices cleared or approved by the FDA. The Federal Office of Public Health impact analysis is scheduled to conclude on 31 December 2026, with ordinance amendments targeted for Q3 2027; the earlier proposal envisages a simplified conformity assessment body review plus quality system, post-market surveillance and possible clinical evidence requirements. FDA authorisations are not yet recognised for Swiss market access, so launch teams should treat this as a planning signal for CH-REP and sequencing decisions.

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FDA relianceCH-REPConformity assessment

EU MDR09 Oct 2026

Revised MDR/IVDR now targeted for adoption in Q2–Q3 2027

Emergo reports that the Commission's MDR/IVDR revision proposals, published at the end of 2025, remain in legislative discussion. The Parliament's IMCO and BUDG committees voted in favour in September 2026, a plenary vote is expected in Q1 2027, and trilogues would follow, with adoption of an agreed text anticipated around mid-2027. The current MDR and IVDR remain fully applicable, and any revised requirements would apply only after a transition period.

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MDR/IVDR revisionTrilogueTimeline

FDA / CDRH07 Oct 2026

HeartBeam receives FDA Breakthrough Device designation for heart attack assessment

FDA granted Breakthrough Device designation to HeartBeam's 3D ECG system for evaluating signs of a possible heart attack outside the hospital, including at home. The company says it builds on its FDA-cleared arrhythmia platform without new hardware and expects to seek FDA alignment on a multicentre pivotal study in the coming months, and has requested enrolment in the TAP programme. The designation gives prioritised FDA interaction during development rather than marketing authorisation.

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Breakthrough DevicePivotal studyTAP

Global06 Oct 2026

UK adopts all 44 recommendations on AI in healthcare regulation as MHRA opens AI Airlock phase 3

The UK government accepted every recommendation from the National Commission into the Regulation of AI in Healthcare, which proposes a more proportionate, lifecycle-based framework with improved classification and qualification pathways and more flexibility for device updates. MHRA is also starting the third phase of its AI Airlock sandbox, focused on postmarket surveillance of AI-enabled devices, and is seeking volunteers. Teams with AI-enabled cardiovascular devices should watch how UK expectations align with FDA and Health Canada machine-learning principles.

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MHRAAI-enabled devicesPostmarket surveillance

FDA / CDRH06 Oct 2026

FDA clears HeartSciences' MyoVista wavECG as a 12-lead resting electrocardiograph

HeartSciences announced 510(k) clearance (K260005) for the MyoVista wavECG, indicated to acquire and interpret ECG signals from adult and pediatric patients in healthcare facilities, with interpretive statements in an advisory role. The clearance does not include the company's separately filed AI-ECG algorithm for impaired cardiac relaxation, and the company says it does not plan to commercialise the device without that algorithm. It illustrates how hardware and AI-algorithm submissions can proceed on separate regulatory tracks.

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510(k)ECGAI algorithm

FDA / CDRH05 Oct 2026

FDA approves new patient-facing software capabilities for Abbott's CardioMEMS HF System

FDA approved updates to Abbott's CardioMEMS HF System that let care teams enable patients to view pulmonary artery pressure readings on their smartphones via the CardioGuide HF app. A Dynamic Treatment Plan feature also lets clinicians set medication-adjustment plans based on pressure changes and send them to patients. Abbott plans to release both later this year, a useful example of post-approval software changes to an implanted-sensor system.

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PMA supplementHeart failureSoftware update

Indonesia MoH01 Oct 2026

Indonesia issues KMK 951/2026 marketing authorisation guideline for software and AI-enabled devices

Indonesia's decree KMK 951/2026, effective 7 September 2026, sets authorisation requirements for SaMD, SiMD and AI-enabled devices, including software lifecycle and cybersecurity documentation, Good Machine Learning Practice, and local clinical validation for some imported AI products. Reported on 1 October, the decree contains no transitional provision for products already registered or under review, so teams should confirm treatment of pending applications with the Ministry.

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SaMDAI / MLIndonesia

FDA / CDRH02 Oct 2026

FDA approves Edwards' Autus, the first expandable pulmonary valve for children

FDA granted premarket approval to Edwards Lifesciences' Autus surgical pulmonary valve, which can be widened later by balloon catheter as a child grows, and which FDA said is the first approved valve to use synthetic polymer rather than animal-tissue leaflets. The approval was based on a 62-patient pivotal study across 12 U.S. sites, with 10-year follow-up continuing. The device had breakthrough designation and is the first pediatric approval from FDA's TAP advisory program, a useful reference for teams planning paediatric cardiovascular PMAs.

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PMAPaediatricBreakthrough device

Global01 Oct 2026

Medtronic secures FDA clearance and CE mark for Affera Prism-2 mapping software

Medtronic announced on 30 September 2026 that its Affera Prism-2 cardiac mapping software has received FDA clearance and a CE mark, alongside a CE mark for the PulseSelect ProxBox Adapter with Proximity Indicator software for its pulsed field ablation system. Prism-2 uses hybrid magnetic and impedance-based tracking to display catheter positions on a 3D map, supporting low- or zero-fluoroscopy procedures. The milestones show software updates to electrophysiology systems moving through U.S. and EU pathways in parallel.

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510(k)CE markPulsed field ablation

Brazil ANVISA01 Oct 2026

ANVISA and Hong Kong Department of Health sign cooperation MoU

Brazil's ANVISA and Hong Kong's Department of Health signed a five-year memorandum of understanding on 23 September 2026 covering cooperation and information exchange across medical products, including medical devices. The MoU is expressly non-binding and creates no reliance or recognition pathway, so device registration in Brazil and MDACS listing in Hong Kong continue under existing requirements. It signals growing regulator-to-regulator collaboration that may shape future pre-market and vigilance practices.

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Regulatory cooperationHong Kong MDACSInformation exchange

EU MDR25 Sep 2026

Intuitive wins CE mark for da Vinci 5 in cardiac surgery

Intuitive said its da Vinci 5 surgical robot received CE mark approval this week for adult cardiac surgery in Europe, including coronary artery bypass procedures, MedTech Dive reported on 25 September 2026. The clearance follows an earlier FDA clearance covering nine heart procedures and positions the company to scale minimally invasive cardiac surgery across Europe through partnerships with cardiac societies on training pathways. For launch teams, it is a useful example of a high-risk surgical indication being added to an already CE-marked platform via a scope extension.

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CE markCardiac surgeryRobotics

FDA / CDRH22 Sep 2026

FDA approves Cordis's sirolimus-eluting balloon for in-stent restenosis

The FDA approved Cordis's Selution SLR drug-eluting balloon on 22 September 2026 for treating coronary in-stent restenosis, making it the first sirolimus-coated balloon approved in the US, MedTech Dive reported. The approval rested on data showing the device was noninferior to standard care in the overall study population, though a secondary endpoint in patients with single-layer restenosis was missed — a reminder for launch teams that meeting a primary PMA endpoint can still leave subgroup questions to manage in labeling and post-approval evidence planning.

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PMADrug-eluting balloonCoronary

China NMPA17 Sep 2026

NMPA finalises inspection criteria for China's revised device GMP

China's NMPA issued final inspection guiding principles on 14 September 2026 (Notice No. 14) for its revised medical device GMP that takes effect 1 November 2026, Pure Global reported. The framework grades 200 inspection items across three risk tiers with explicit thresholds for pass, self-correction, rectification, or failure/suspension outcomes, and sets out how pending licence applications and uninspected Class I filings transition onto the new criteria from the effective date.

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GMPNMPA inspectionChina registration

FDA / CDRH17 Sep 2026

FDA clears LigaSure vessel-sealing instrument for Medtronic's Hugo robot

The FDA has cleared Medtronic's LigaSure RAS vessel-sealing instrument for use with the Hugo robotic-assisted surgery system, MedTech Dive reported on 17 September 2026. LigaSure is already widely used in open and laparoscopic surgery, so the clearance extends an established energy instrument to a robotic platform rather than introducing a new technology. It is a useful example for launch teams of how instruments and accessories are cleared separately from the host system they attach to.

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510(k)Surgical roboticsEnergy devices

EU MDR16 Sep 2026

Convergence panel: MDR/IVDR reform still awaiting Parliament and Council

At RAPS Convergence 2026 in Charlotte, a panel drawn from the European Commission, industry and notified bodies reviewed the targeted MDR and IVDR reforms proposed in December 2025, which still require adoption by the European Parliament and Council before they can take effect. Commission senior expert Peter Bischoff-Everding described the guiding aims as moving from fixed procedures to risk-based oversight, adding a legal basis for structured dialogue with notified bodies, reducing technical documentation sampling for medium-risk devices and removing five-yearly recertification. Notified body representatives pressed for risk-adaptive surveillance and access to EUDAMED data, while attorney Erik Vollebregt cautioned that simplification should not be read as a lowering of evidence or safety requirements.

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MDR revisionNotified bodiesEUDAMED

EU MDR15 Sep 2026

Intuitive's single-port da Vinci SP gains CE mark for a new indication

Intuitive's single-port da Vinci SP system has received a CE mark covering transvaginal gynaecologic procedures, adding to the indications already authorised for the platform in Europe, MedTech Dive reported on 15 September 2026. The change is an expansion of scope on an existing CE-marked system, a route that manufacturers of platform technologies often use to broaden European access incrementally.

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CE markIndication expansionScope extension

US CMS11 Sep 2026

CMS finalises expanded TAVR coverage, adding asymptomatic patients

The Centers for Medicare and Medicaid Services published its finalised national coverage determination for transcatheter aortic valve replacement on 10 September 2026, extending Medicare coverage to patients with asymptomatic severe aortic stenosis under coverage with evidence development while removing the CED requirement for symptomatic patients. The decision follows the FDA's 2025 expanded indication for Edwards' Sapien 3 platform, which was based on the EARLY TAVR study. CMS also said it will review TAVR coverage in aortic regurgitation, with a proposed decision expected by March 2027.

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TAVRReimbursementEvidence development

Brazil ANVISA10 Sep 2026

ANVISA clarifies use of recognized standards in device technical files

Brazil's ANVISA published guidance on 1 September 2026 explaining how recognized technical standards can support safety and performance evidence under RDC No. 848/2024. The agency stresses that recognition is not itself product approval or certification and that manufacturers remain responsible for demonstrating full compliance; the current published list covers materials used in orthopedic implants, and use of listed standards remains voluntary.

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Recognized standardsTechnical documentationRDC 848/2024

Australia TGA09 Sep 2026

TGA reclassifies saline-only flush devices, revises CDSS software exemption

Australia's Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations, registered 7 September 2026, add a new Class IIa classification for non-invasive, saline-only flush and patency devices effective 8 September 2026. A separate change effective 1 November 2026 rewrites the clinical decision support system (CDSS) software exemption from three to five cumulative conditions.

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Device classificationCDSS softwareARTG

FDA / CDRH08 Sep 2026

FDA approves Abbott's dual-energy TactiFlex Duo ablation catheter

The FDA approved Abbott's TactiFlex Duo ablation catheter on 8 September 2026, a single device delivering both pulsed-field and radiofrequency energy for treating atrial fibrillation, letting physicians switch energy modes during a procedure. The approval follows an earlier CE mark and FlexPulse IDE study data presented at the ESC Congress showing safety and efficacy in paroxysmal AFib patients.

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PFAAblation catheterAtrial fibrillation

FDA / CDRH27 Aug 2026

J&J issues early alert on Impella heart pump controller after deaths, injuries

Abiomed, a J&J subsidiary, advised hospitals to remove automated Impella heart pump controllers over a purge pressure sensor assembly issue that the FDA's early alert links to 3 deaths and 37 serious injuries. This purge-cassette recognition failure, occurring in roughly 0.2% of cases, is a separate issue from the introducer-sheath leak behind the Impella Class I recall reported on this page in August 2026; affected hospitals can continue using existing inventory while awaiting service.

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Early alertImpella controllerPurge cassette failure

Australia TGA13 Aug 2026

TGA consults on sharing more medical device safety information publicly

The TGA opened a consultation on proposals to expand what it can lawfully disclose about medical devices following post-market reviews or investigations, giving patients and clinicians more visibility into safety, quality and performance findings. The consultation runs until 2 October 2026 and aligns with the WHO Global Benchmarking Framework.

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Post-market surveillanceTransparencyConsultation

FDA / CDRH10 Aug 2026

FDA classifies Impella introducer sheath leak as Class I recall

The FDA confirmed a Class I recall for certain 14Fr and 23Fr introducer sheaths used with Abiomed/Oscor Impella heart pump sets, after identifying a manufacturing defect that can cause leakage and access-site bleeding. Hospitals may continue using existing inventory but should watch for leakage and consider a device exchange; the action follows an early alert issued in June 2026.

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Class I recallImpellaAccess-site bleeding

China NMPA02 Jul 2026

NMPA drafts clinical evaluation pathway for cardiac RF ablation devices

China's NMPA released a draft guideline on clinical evaluation for cardiac radiofrequency ablation devices and catheters, open for feedback through 30 July 2026. The framework clarifies when a full clinical trial is required versus when a same-variety comparison pathway using prior-generation and overseas data may be acceptable — directly relevant to manufacturers with ablation systems already registered in China.

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Class IIIClinical evaluationElectrophysiology

EU MDR01 Jul 2026

European Parliament rapporteur proposes 130+ amendments to MDR/IVDR revision

The rapporteur for the European Parliament's Public Health (SANT) Committee published a draft report responding to the Commission's proposal to simplify the MDR and IVDR, putting forward more than 130 amendments aimed at faster, lighter rules. Technical discussions continue through autumn 2026, with a Parliament plenary vote expected around year-end.

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MDR revisionSANT CommitteeSimplification

EU MDR12 Jun 2026

EU MDR transitional timelines: what high-risk device makers should confirm now

With staggered transition provisions for legacy devices, manufacturers of Class III and implantable devices should re-confirm Notified Body capacity and conformity-assessment scheduling well ahead of certificate expiry.

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Class IIINotified BodyTransition

FDA / CDRH09 Jun 2026

FDA refines 510(k) predicate expectations for cardiovascular catheters

Updated guidance emphasises clearer predicate rationale and performance testing for PTCA and peripheral angioplasty catheters. Teams should align bench, animal, and clinical evidence to the stated product code early.

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510(k)PredicateCardiovascular

Swissmedic05 Jun 2026

swissdamed registration: importer and CH-REP obligations in focus

As Switzerland's device database expands, economic operators are reminded to verify CH-REP appointments, CHRN registration, and importer linking to keep market access uninterrupted.

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CH-REPswissdamedImporter

EU MDR28 May 2026

EUDAMED modules: planning for mandatory use

As additional EUDAMED modules move toward mandatory status, manufacturers should prepare actor, UDI, and device registration data now to avoid bottlenecks at go-live.

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EUDAMEDUDIRegistration

China NMPA22 May 2026

NMPA clarifies clinical evaluation routes for imported devices

Refined expectations on clinical-evaluation exemptions and local data requirements affect registration strategy for overseas manufacturers entering the Chinese market.

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RegistrationClinical dataImports

Japan PMDA18 May 2026

PMDA consultation pathways for novel cardiovascular implants

Early consultation continues to shorten review for high-risk implants. Sponsors should scope Shonin requirements and foreign clinical-data acceptability before filing.

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ShoninConsultationImplants

FDA / CDRH11 May 2026

Drug-eluting devices: combination-product evidence expectations

For drug-coated balloons and drug-eluting stents, regulators continue to stress integrated safety and effectiveness data reflecting the ancillary medicinal action.

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PMACombinationDrug-eluting

Global06 May 2026

Harmonising evidence across markets with a single dossier core

Teams launching in parallel are building a shared evidence core — clinical evaluation, risk management, biocompatibility — then layering jurisdiction-specific requirements on top.

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StrategyEvidence coreMulti-market

Australia TGA29 Apr 2026

TGA ARTG inclusion: leveraging comparable overseas approvals

Comparable-overseas-regulator pathways can streamline ARTG inclusion. Confirm conformity-assessment evidence and sponsor responsibilities to use them effectively.

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ARTGComparableSponsor