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Notified body association Team-NB has suggested changes to the European Commission’s proposals for risk-adaptive surveillance of medical devices.

The European Commission has published two delegated acts that expand the list of well-established technologies (WET) under the Medical Devices Regulation (MDR) that are exempt from conducting clinical investigations and technical assessments. The first regulation applies to implantable devices and Class III devices, while the second regulation focuses on Class IIb implantable devices.

The European Commission has adopted new harmonized standards for medical devices and diagnostics but established a five-year transition period to give manufacturers time to adapt their processes.

Researchers from the European Medicines Agency (EMA) have published a paper on regulatory research priorities for AI across the medicine lifecycle.

The Pharmaceuticals and Medical Devices Agency (PMDA) published guidance on using a weight of evidence (WOE) approach to assessing the toxicity of monoclonal antibodies in Japan.

MedTech Europe has voiced broad support for proposed changes to the In Vitro Diagnostic Regulation (IVDR), welcoming many proposals and pushing for the strengthening of some revisions.

The New Zealand government has adopted rules on “consent by verification,” creating a pathway that will fast-track the review of medicines approved by two or more reference regulatory agencies.

A Health Technology Assessment Regulation (HTAR) governance body has published guiding principles on data transparency.

An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.

Australia’s Therapeutic Goods Administration (TGA) has released guidance on manufacturing, supplying, and advertising compounded medicines to support compliance with its regulatory requirements.