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The US Food and Drug Administration (FDA) on Thursday issued a draft guidance that would significantly revise its previous guidance on using voluntary patient...
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...
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...
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)....
USA – FDA unveils FY 2025 user fee rates
The US Food and Drug Administration (FDA) has published its user fee rates for fiscal year 2025 across its prescription drug, generic drug, biosimilar,...
Europe – Commission Implementing Decision (EU) 2024/2120 of 30 July 2024 renewing...
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2017/745 of the European Parliament and of...
USA – FDA finalizes COVID-era guidance on container closure changes
The US Food and Drug Administration (FDA) has finalized a guidance to assist sponsors in reporting common changes made to glass vials and stoppers,...
Europe – Medical device competent authority statement on the status of the EU regulatory...
National Competent Authorities have endorsed a consensus statement and shared it with the European Commission on the status of the EU regulatory framework for...
