Critical European Commission medtech regulatory reports now in the wings
This article was originally published in SRA
The European Commission will be issuing in June – most likely in the latter half of the month – its report assessing the impact of measures taken by the regulatory authorities following former Commissioner John Dalli’s urgent call in 2012 to improve medical device safety1-3.
You may also be interested in...
With hospitals throughout the EU short of urgently needed COVID-19 medical supplies, including respiratory equipment, there are ways for companies to sell and deliver their products quickly.
With many non-CE marked products being allowed onto various EU member state markets, who is going to monitor compliance? TÜV-SÜD’s Bassil Akra calls for cooperation to avoid unsafe products being used on patients.
Commission Provides Regulatory Advice For COVID-19 Medtech Sector Entrants Amid Counterfeit Concerns
A new European Commission guidance document explains the regulatory basics and emergency market entry criteria for new entrants to the devices sector amid the COVID-19 crisis.