EU Expands Laboratory Oversight for Highest Risk In Vitro Diagnostic Devices

The European Union (EU) has expanded oversight of Class D in vitro diagnostic medical devices under Regulation (EU) 2017/746, known as the In Vitro Diagnostic Regulation (IVDR).

BIS Seeks Public Feedback on Draft Standards for Medical Devices and Healthcare

The Bureau of Indian Standards (BIS), through its Medical Equipment and Hospital Planning Department,

NATA Seeks Experts in Software as Medical Devices and AI for Human Pathology Advisory Committee

The National Association of Testing Authorities, Australia (NATA) is inviting expressions of interest to join its Human Pathology Accreditation Advisory Committee,

Denmark Aligns Accreditation Rules for Referral Laboratories and Specialists With ISO 15189

Denmark has revised its national accreditation rules for the use of referral laboratories and external specialists to align with the Danish version of ISO 15189:2022 for medical laboratories.

FDA Aligns U.S. Device Rules With ISO 13485, Replaces QSR With QMSR

The U.S. Food and Drug Administration (FDA) has replaced its long-standing Quality System Regulation (QSR) with the new Quality Management System Regulation (QMSR), changing the legal framework for quality management in the U.S. medical device sector.

NEN Seeks Experts for Clinical Research Standards Committee

The Netherlands Standardization Institute (NEN) is inviting experts to join its Clinical Research standards committee to help shape international standards for clinical investigations of medical devices.

Clearlab Earns MDSAP, ISO 13485 and EU MDR Certifications for Contact Lenses

Clearlab, a manufacturer of vision correction products and lens care solutions, has obtained combined certification under the Medical Device Single Audit Program (MDSAP), ISO 13485, and the European Union Medical Device Regulation (EU MDR).

EU Medical Device Database EUDAMED Opens First Mandatory Modules

The European Commission has published the first four functional modules of EUDAMED, the EU database for medical devices and in vitro diagnostic devices.

Italy Launches Accreditation for ISO 7101 Healthcare Quality Systems

Italy has opened accreditation for certification bodies that audit healthcare organizations against UNI ISO 7101:2024, the standard for quality management in health services.

IEI Secures TFDA QMS Approval and ISO 13485 Certification

IEI Integration Corp, a Taiwan-based provider of medical and industrial computing systems,

NEN Sets Initial Scope For New Guideline On Sustainable Medical Devices

The Netherlands Standardization Institute (NEN) has set the initial scope for developing a new Dutch Practice Guideline (NPR) on sustainability in medical devices.

Mexico Recognizes MDSAP as Equivalent to National Medical Device GMP

Mexico has issued a new interpretation rule for the NOM-241-SSA1-2025 standard on good manufacturing practices (GMP) for medical devices, confirming that

ISO 20022 Series Update Sets New Rules as Payment Systems Prepare for Implementation

The International Organization for Standardization (ISO) has published updated and new parts in the ISO 20022 series, as major payment systems advance their implementation of the standard on closely aligned timelines.

Consultation Underway On Global Standard For AI Testing In Medical Devices

An international voting and consultation phase is underway for a new standard that sets requirements for testing artificial intelligence (AI) and machine learning (ML) in medical devices.

MSC Opens Review Of Chain Of Custody Standard For Public Consultation

The Marine Stewardship Council (MSC) has launched a public consultation on proposed revisions to its Chain of Custody Standard, inviting stakeholders across the seafood supply chain to provide feedback until May 30, 2026.

Call For Food Sector Stakeholders To Influence ISO 22000 Revision Through National Committees

Food sector stakeholders who apply ISO 22000 in practice have the opportunity to influence its revision by bringing real-world experience into the process.

AutoCarbon Certification Scheme Due in 2027 As Pilot Phase Begins

The International Automotive Oversight Bureau (IAOB) has announced AutoCarbon,

ISO 14064-5 Introduces Guidance For Remote Verification Of Greenhouse Gas Data

The International Organization for Standardization (ISO) has introduced ISO 14064-5, which provides guidance on how to carry out verification and validation of greenhouse gas (GHG) data using remote techniques in digital environments.

ISO 9002 Revision Moves To Draft International Standard Stage

The revision of ISO 9002 has entered the Draft International Standard (DIS) stage, with ISO/TC 176/SC 2, the ISO subcommittee responsible for quality systems, advancing the project into formal consultation. 

ISO 37304 Compliance Management Certification Standard Advances to Final Draft Stage

The International Organization for Standardization (ISO) has advanced ISO 37304 to the final draft international standard (FDIS) stage.

One Vote Tips Toward New Edition Of ISO/IEC 17065 Over Amendment

One vote has tipped the decision toward publishing a new edition of ISO/IEC 17065 instead of issuing a separate amendment, following a closely split ballot within the International Organization for Standardization (ISO).

Is ISO 25500 a Solution to Supply Chain Data Challenges?

ISO 25500, a draft series of standards from the International Organization for Standardization (ISO), is presented by the Electronic Commerce Code Management Association (ECCMA) as a possible way to address long-standing problems with unreliable data across global supply chains.

IFS Updates Food, Logistics, Broker And Pacsecure Doctrines To Clarify Certification Rules

The International Featured Standards (IFS) has published updated doctrine documents for its current standards covering food production, logistics, brokerage, and packaging materials, clarifying how certification requirements should be applied without revising the standards themselves.

PAS 25535 on Sustainability in Asset Management Reaches Draft Stage

PAS 25535, a specification focused on integrating sustainability into asset management systems, has reached the committee draft stage within the International Organization for Standardization (ISO), marking the close of its initial comment period.