January 24, 2018

What does the European Commission announcement on the withdrawal of the UK from the European Union mean for the MedTech industry?

The European Commission issued the following communication on 10th January: “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products.” This document is not written specifically for the medtech industry but for all sectors, outlining the principles for the withdrawal of the UK from the European Union. The medtech sector has… read more

January 22, 2018

PRESS RELEASE: UL issues first marketing claim verification for Optical Field of View to Visunex Medical System Co., Ltd.

UL, a global safety science organization, has issued the first UL Marketing Claim Verification and UL Verified Mark in the field of medical devices to the Ophthalmic Imaging System, manufactured by Visunex Medical System Co., Ltd. out of Suzhou China. Read the press release here.

August 30, 2017

MHRA launches an introductory guide to the MDR and IVDR regulations

Manufacturers need to demonstrate that their medical device meets the requirements in the MDR or IVDR by carrying out a conformity assessment. The assessment route depends on the classification of the device. Read the full document here

August 30, 2017

PRESS RELEASE: UL Announces GREENGUARD Certification for Medical Devices in Breathing Gas Pathways

August 28, 2017

PRESS RELEASE: UL Becomes Recognized Auditing Organization Under Medical Device Single Audit Program