Medical Devices

European Commission Opens Call for Evidence on Targeted Revision of EU Medical Device and IVD Rules

The European Commission is running a call for evidence on a targeted revision of EU medical device and in vitro diagnostic regulations, with stakeholders invited to submit feedback between January and July 2026. This signals potentially significant simplification of MDR/IVDR requirements, with implications for certification timelines, compliance costs, and future regulatory expectations for device manufacturers and healthcare systems.

15 May 2026, 17:44ec.europa.euEuropean Union

Netherlands Grants Temporary MDR Exemption To Andocor NV For Arterial Cannulas And Aorta Catheter

The Dutch Minister of Health has granted Andocor NV a temporary exemption under the EU Medical Devices Regulation for specific arterial cannulas and an aorta catheter, effective through 4 September 2026. This time-limited derogation ensures short-term availability of these devices in the Netherlands but requires hospitals and distributors to plan for MDR-compliant arrangements once the exemption expires.

15 May 2026, 17:44zoek.officielebekendmakingen.nlNetherlands

US Senate Introduces Bill to Expand Electronic-Only Labelling for Devices

In May 2026, US senators introduced S.4519, a bill to amend the Federal Food, Drug, and Cosmetic Act so that required labeling for a broader range of devices could be provided solely by electronic means. If enacted, this would give device manufacturers more flexibility around US labelling formats, potentially lowering printing and distribution costs while requiring careful planning for digital access and usability.

15 May 2026, 16:12congress.govUnited States

China NMPA Reports Four Illegal Online Sales of Medical Devices

In May 2026, China’s NMPA published four concluded enforcement cases against companies selling medical devices online via major e-commerce platforms in breach of registration, licensing, and labelling requirements. These cases signal sustained regulatory scrutiny of medical-device sales on Chinese online marketplaces, raising compliance expectations for manufacturers, distributors, and platforms to align listings and documentation with national rules.

15 May 2026, 13:30nmpa.gov.cnChina

EU Council Working Party Schedules Meeting on Genetically Modified Microorganisms and Organ Processing Directive (22 May 2026)

EU ministers’ officials will meet on 22 May 2026 to examine a third Presidency compromise text for an EU directive amending the GMO and organ-transplant directives, focusing on placing genetically modified microorganisms on the market and organ processing. This signals continued political negotiation on the scope and conditions for GMM-based therapies and organ-processing technologies in the EU, which could lead to new compliance obligations for biotech, pharmaceutical and transplant operators once the directive is finalised.

15 May 2026, 12:50data.consilium.europa.euEuropean Union

US FDA Updates Medical Device Inspection Program 7382.850 and Retires QSIT

In May 2026 the US FDA published an updated compliance program for inspecting medical device manufacturers that retires the QSIT model and implements a QMSR-aligned, risk-based inspection framework effective 2 February 2026. Medical device companies should reassess their quality systems, internal audits, and inspection readiness to ensure alignment with ISO 13485-based QMSR expectations across design controls, postmarket surveillance, tracking, and UDI traceability.

14 May 2026, 19:09fda.govUnited States

France CESE Recommends Reforms to Health-Crisis Preparedness and Medical Supply Security

In April 2026 France’s Economic, Social and Environmental Council issued a major opinion urging reforms to health-crisis governance, research funding, data access, and especially strategic autonomy and supply security for medicines, medical devices, and protective equipment. If translated into legislation and procurement rules, these recommendations would tighten expectations on industry around resilient supply, EU-based production, and data-enabled preparedness, shaping future market conditions for healthcare and life-science companies.

14 May 2026, 18:37vie-publique.frFrance

Swissmedic Encourages Use of New ISO 14155:2026 for Medical Device Clinical Investigations

Swissmedic has announced the availability of ISO 14155:2026, the revised good clinical practice standard for medical device clinical investigations, and explicitly welcomes and encourages its use. This strengthens expectations around safety planning and ongoing surveillance, so sponsors and investigators in Switzerland should plan to align clinical investigation procedures, documentation, and monitoring frameworks with the new edition.

14 May 2026, 18:33swissmedic.chSwitzerland

Switzerland: swissdamed Device Registration Mandatory From 1 July 2026; GPMV‑Spital Materiovigilance Guidance Issued

Swissmedic has confirmed that registration of IVDs and medical devices in the national swissdamed database becomes mandatory from 1 July 2026, with a transition period until 31 December 2026, and has issued new GPMV-Spital guidance on materiovigilance in hospitals. Device manufacturers, importers and hospital operators in Switzerland should plan now to complete all necessary swissdamed registrations on time and align their internal vigilance systems with the new guidance to avoid non-compliance and market disruption.

14 May 2026, 12:30swissmedic.chSwitzerland

China NMPA Approves Proton Therapy System For Marketing

China’s National Medical Products Administration has approved a proton therapy system from 迈胜医疗设备有限公司 for marketing, as announced on 12 May 2026. This first domestic compact single-room proton therapy system should expand access to advanced radiotherapy within China’s existing medical device framework without changing underlying regulations.

14 May 2026, 12:26nmpa.gov.cnChina

EU Council Working Party Schedules 21 May 2026 Meeting on Medical Devices Rules Simplification (Cluster 4)

The Council of the EU’s Working Party on Pharmaceuticals and Medical Devices will meet on 21 May 2026 to examine cluster 4 of the proposal to simplify rules on medical and in vitro diagnostic devices, focusing on post-market surveillance and vigilance. This is a further procedural step in Council scrutiny of potential future changes to post-market compliance and vigilance obligations for EU medical device and IVD manufacturers, without yet altering current legal requirements.

14 May 2026, 09:33data.consilium.europa.euEuropean Union

Thailand MOPH Drafts Consolidated Medical Device Standards With One-Year Transition Period

Thailand’s Ministry of Public Health has notified a draft consolidated medical device standards regulation that repeals earlier notifications and will require manufacturers and importers to meet updated annexed standards, with a one-year transition period after it takes effect. Medical device companies supplying the Thai market should assess which products fall under the new annex, map against the referenced international standards, and plan design, testing and documentation changes in advance of publication in the Royal Gazette.

14 May 2026, 09:25members.wto.orgThailand

Taiwan TFDA Issues Certification Procedure for Entrusted Medical Device Inspection Bodies

In May 2026, Taiwan’s Food and Drug Administration put into effect a detailed certification regime for third-party agencies that will be entrusted to inspect medical device firms’ quality management and distribution systems, and is now accepting applications. This formalises how external inspection capacity will be accredited and supervised under the Medical Devices Act, signalling tighter, more systematic oversight of medical device supply chains in Taiwan and new qualification expectations for organisations seeking this work.

13 May 2026, 11:58fda.gov.twTaiwan

Australia TGA Adds UK MHRA-Approved Bodies to Guidance on Comparable Overseas Medical Device Regulators

In May 2026, Australia’s Therapeutic Goods Administration updated its medical device guidance to recognise UK MHRA-approved bodies as comparable overseas regulators alongside existing EU, US, Canadian, Japanese and Singaporean authorities. This widens the overseas evidence sponsors can use to support ARTG device registrations and abridged conformity assessments, potentially shortening time-to-market for UK-tested devices while leaving core legal obligations unchanged.

13 May 2026, 08:03tga.gov.auAustralia

Australia TGA Clarifies AusUDID Production vs Pre-Production and 30-Day UDI Data Rules

The Australian Therapeutic Goods Administration has clarified how sponsors and manufacturers must use the AusUDID production and pre-production environments, strengthened 30-day rules for maintaining accurate UDI records, and confirmed that only live AusUDID data counts toward UDI compliance. This update tightens governance expectations for Australian medical device sponsors, especially those using HL7 SPL or other automated submissions, who may need to adjust systems and data workflows so validated production records underpin device traceability and regulatory assurance.

12 May 2026, 17:52tga.gov.auAustralia

US FDA Classifies Orthopedic Infection Nucleic Acid and Resistance Marker Device as Class II With Special Controls

FDA has finalized a class II (special controls) classification and codified a new device type at 21 CFR 866.3988 for nucleic-acid-based diagnostics that detect microorganisms and resistance markers in suspected orthopedic infections in the United States. This creates a defined 510(k) pathway and clear validation, labeling, and sample-collection expectations that manufacturers of such multiplex orthopedic infection panels must meet when bringing products to or updating them on the US market.

12 May 2026, 15:27federalregister.govUnited States

Italy Consiglio di Stato Refers Constitutional Challenge on 0.75% Medical Device Levy

In February 2026 Italy’s Consiglio di Stato referred to the Constitutional Court a constitutional challenge against the 0.75% turnover levy that funds the national medical device governance fund for supplies to the public health service. Medical device and in vitro diagnostic manufacturers subject to this Italian levy should monitor the case, as a future ruling could materially change the cost and design of market access obligations for devices sold to the national health service.

12 May 2026, 12:50gazzettaufficiale.itItaly

New York Senate Advances Amended PFAS Bill S07839B On Medical Adhesives And Bandages

On 27 April 2026, the New York Senate amended PFAS bill S07839 to version S07839B and advanced it to third reading, progressing a proposal to ban PFAS in medical adhesives and bandages one year after the law takes effect. If enacted, manufacturers and sellers of covered medical adhesives and bandages in New York will need to eliminate intentionally added PFAS, comply with a DEC‑set PFAS concentration limit, and manage certificate‑of‑compliance and civil‑penalty risks aligned with the amended Environmental Conservation Law.

12 May 2026, 12:48assembly.state.ny.usUnited States

EU Council Working Party on Pharmaceuticals and Medical Devices — Presidency Flash on Interinstitutional File 2025/0405(COD)

The Council Working Party on Pharmaceuticals and Medical Devices held a meeting on 08 May 2026 on interinstitutional file 2025/0405(COD), with the Presidency issuing a non-public flash note recorded in the Council register. This confirms that Council negotiations on a new EU pharmaceuticals and medical devices legislative file are progressing, but no new binding obligations or concrete deadlines can be inferred from this entry alone.

11 May 2026, 11:59consilium.europa.euEuropean Union

US ITC Issues Limited Exclusion and Cease-and-Desist Orders in Section 337 Investigation on Photodynamic Therapy Systems

The US International Trade Commission has issued a final Section 337 determination in Investigation 337-TA-1411 on photodynamic therapy systems, finding a violation and ordering a limited exclusion order and cease-and-desist orders against four Biofrontera entities. The decision restricts US market access for the respondents' photodynamic therapy systems and related pharmaceuticals and signals the continuing use of Section 337 to enforce patent rights and shape competition in advanced medical technologies.

11 May 2026, 11:38federalregister.govUnited States