Medtech Advised How To Stay On Top Of EU Regulatory Reform
This article was originally published in SRA
Medtech companies should start reviewing sooner rather than later which of their product portfolios will remain on the market in Europe under the new Medical Device Regulation after the legislation is adopted. The next step will be to prioritize which of these products should be brought under compliance with the MDR first, then ensure timely assessments by notified bodies.
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.