The Medicines & Healthcare products Regulatory Agency (MHRA) recently released a new guidance document titled “Single-use medical devices: UK guidance on re-manufacturing” published on July 5, 2016 for the purpose of making a clear distinction between re-manufactured single-use devices (SUDs) and devices that are reprocessed or fully refurbished.

Am 11. Februar 2015 wird die Medicines and Healthcare Products Regulatory Agency (MHRA), die im Vereinigten Königreich für den Medizinproduktemarkt zuständige Behörde, ein neues Online-System zur Registrierung risikoarmer Produkte einführen.

A UK Department of Health review of how British regulators managed PiP defective breast implants has identified several regulatory improvements the Medicines and Healthcare Products Regulatory Agency (MHRA) should adopt to handle similar events in the future.

This regulation outlines how Instructions for Use may be provided in electronic format to professional users for certain medical devices under the Medical Device Directive and Active Implantable Medical Device Directive.

Neue elektronische Kennzeichnungsvorschriften der Europäischen Kommission werden am 1. März 2013 in Kraft treten. Diese...

The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK medical device market regulator, has set up an “innovation office” in an effort to provide a more efficient market authorization process for manufacturers of cutting-edge products.

Die Medicines and Healthcare Products Regulatory Agency (MHRA), die im Vereinigten Königreich für den Medizinproduktemarkt zuständige Behörde, hat eine

Healthcare regulators in the UK are now requiring medical device manufacturers and sponsors to register their clinical trials in publicly accessible databases such as the EU Clinical Trials Register or ClinicalTrials.gov in the US.

Die Gesundheitsbehörden im Vereinigten Königreich verlangen nun von Medizinprodukte-Herstellern und Sponsoren, dass diese ihre klinischen Studien in öffentlich zugänglichen Studienregistern wie dem EU Clinical Trials Register oder auf ClinicalTrials.gov in den USA registrieren.

The British Medicines and Healthcare products Regulatory Agency (MHRA), responsible for overseeing the UK’s medical device market, is launching a new online registration system for low-risk devices on February 11, 2015.