Latest European device standards published:
This article was originally published in Clinica
Executive Summary
The latest series of European standards for medical devices and diagnostics have been published in the Official Journal of the European Communities (C 288/41). Manufacturers conform to these standards to imply that they meet the relevant essential requirements of the European Union medical device directives on in vitro diagnostics (IVDs), medical devices (MDs) and active implantable medical devices (AIMDs). The new standards or parts of standards cover: culture media for microbiology (IVD); tests for in vitro cytotoxicity (MD and AIMD); validation and routine control of sterilisation by irradiation (MD); and 15 parts to the standards on electricomedical equipment ranging from gamma beam therapy equipment to endoscopic equipment and infant radiant monitors (AIMD).
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.