Europe – Notification of a Body in the framework of a technical harmonization directive

Body Name ISTITUTO SUPERIORE DI SANITA' Address Viale Regina Elena, 299 00161 - ROMA Country Italy Phone +39 06 49906146 Fax +39 06 49903150 Email roberta.marcoaldi@iss.it Website www.iss.it Body Number 0373 Last approval date 03/05/2016...

USA – FDA Authorizes First Over-the-Counter Hearing Aid Software

Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with...

USA – Industry groups call for changes to FDA’s guidance on use-related risk analyses

Stakeholders want the US Food and Drug Administration (FDA) to provide more clarity on its expectations for use-related risk analyses (URRA) for “stand-alone” non-combination...

Canada – The evolution of Canada’s medical device regulatory framework

The evolution of the medical device regulatory framework in Canada is not as well understood as those of other major jurisdictions such as the...

USA – FDA updates patient preference guidance to span the product life cycle

The US Food and Drug Administration (FDA) on Thursday issued a draft guidance that would significantly revise its previous guidance on using voluntary patient...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – EU Update: Current State of Medical Device Regulations

Amending legislation published to extend the transition of legacy IVDs and roll out EUDAMED Regulation 2024/1860 was officially released to extend the transition time for legacy...

International – IMDRF Document Implementation Report – Final document

This report (30 August 2024) provides details on the status of various medical device regulations, as self-identified by IMDRF members. It covers documents on...
ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.

International – ISO/DIS 10993-1(en) Biological evaluation of medical devices — Part 1: Requirements and...

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried...
Statement on the Investigational Use of Marketed Drugs in Clinical Trials

Canada – Notice on Health Canada’s proposed changes to the guidance on recognized standards...

Health Canada has updated the: List of recognized standards for medical devices and Guidance on using standards to support compliance with the Medical Device Regulations The...

Europe – New pilot programme to support orphan medical devices

EMA has launched a pilot programme for expert panels to support the development and assessment of orphan medical devices in the European Union (EU)....

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