Commission’s One-Year MDR Delay Text Contains EU-Wide Derogation Proposals Too
The race is now on to get formal adoption of European Commission proposal postponing the MDR by one year and allowing more devices on the market more quickly. But potential hurdles are in the way as experts advise caution.
You may also be interested in...
The EU is pulling out all the stops to have the one-year delay to the MDR adopted before it is too late, and a crucial vote will take place on 16 April.
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.
Official: European Parliament Signs Off Council of EU’s 4 Extra Years For Class I Upclassified Devices
Medtech industry gets best seasonal gift as Council of EU and European Parliament agree on longer transition period for upclassified Class I medical devices. But how many notified bodies are still auditing products under the medical device directives?