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Europe

Set Alert for Policy and Regulation - Europe

New EU Rules Allow Buyers To Procure COVID-19 Devices ‘Within Hours’

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.

Medical Device Europe EU

Latest From Policy, Regulation & Europe

MDR Delay: Is It All Good News Or Does It Bring Its Own Problems?

In responding to industry’s plea for more time to comply with the EU’s MDR, the European Commission’s proposed one-year delay may also create some unwelcome repercussions for manufacturers and notified bodies.

EU Europe

Notified Body Expert Akra Calls For Special Taskforce Measures To Oversee New COVID-19 Products

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.

Europe EU

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.

Medical Device Europe

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.

Medical Device Europe

UK IVDs Firms Working Flat Out On COVID-19 Tests, As Govt Promises Test Capacity Increase

Confusion is rife over low UK testing levels to confirm COVID-19 in health care staff and patients, and comparisons with measures taken in similar-sized economies have been unfavorable. Diagnostics manufacturers are not to blame, says the industry.

United Kingdom Coronavirus COVID-19

UK Regulator Puts Energies Into COVID-19 While Other Services May Take Longer

With finite resources, the UK’s regulatory agency responsible for health care products is rapidly addressing COVID-19 medtech issues. But shifting its focus will cause delays elsewhere.

Europe EU
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