Consultation Open on Safe Handling of Sterile Medical Equipment in Norway

Standard Norway has opened a consultation on a new technical specification that sets clear requirements for storing, handling, and transporting sterile medical equipment in Norwegian healthcare services.

Russia Now Requires Local Representative for Foreign Medical Device Registration

Foreign manufacturers with medical devices registered in Russia must appoint a Russian Authorized Representative (RUS REP) or update existing representative details by August 31, 2025.

Public Consultation Opens in Norway on Patient Pathway Standard for Diagnostic Imaging

A draft Norwegian version of a new European standard for the patient pathway in diagnostic imaging is now open for public consultation until May 1.

UK to Tighten Post-Market Rules for Medical Devices Starting June 2025

The UK’s new Post-Market Surveillance (PMS) regulations for medical and in vitro diagnostic devices will come into force on June 16, 2025.

NHSGGC Biorepository Becomes First in UK to Earn UKAS Accreditation Under ISO 20387

NHS Greater Glasgow and Clyde's (NHSGGC) Biorepository is the first facility in the UK to receive UKAS accreditation under ISO 20387:2018, the international standard for biobanking.

NEN Seeks Dutch Experts for In Vitro Diagnostics Standards Committee

The Netherlands Standardization Institute (NEN) is seeking Dutch experts to join its In Vitro Diagnostics (IVD) standards committee.

NSAI Seeks Feedback on Potential Revisions to ISO 13485 for Medical Device Quality

The National Standards Authority of Ireland (NSAI) is inviting users of ISO 13485:2016 to share their input on possible revisions through a survey.

Standard Norway Seeks Experts for European Healthcare Standards Group

Standard Norway is inviting 4-6 professionals to join the newly established CEN/CENELEC SAG Healthcare standards group, which aims to identify and address standardization needs in the healthcare sector.

NEN Initiates Development of Sustainability Guidelines for Medical Devices

In April 2025, the Netherlands Standardization Institute (NEN) will begin creating a Dutch Practical Guideline (NPR) focused on the sustainability of medical devices.

Medical Device Industry at Midpoint in Transition to FDA’s ISO 13485-Based QMSR

A year ago, the FDA adopted ISO 13485 into its Quality System Regulation, rebranding it as the Quality Management System Regulation (QMSR).

Topolšica Hospital Achieves Slovenia's First ISO 7101 Certification

Topolšica Hospital has become the first medical institution in Slovenia to earn the ISO 7101 certification for management systems for quality in healthcare organizations.

How EU’s Unique Device Identification Enhances Medical Device Safety

The European Medical Device Regulation (EU) 2017/745 (MDR) requires all medical device manufacturers to assign a Unique Device Identification (UDI) to their products.