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EU Regulatory Roundup, September 2023: Dismantling Regulatory Barriers To Medtech Innovation

 
• By Amanda Maxwell

The call for more to be done about the EU’s regulatory hurdles to innovation, as well as for improvements to governance, has now grown to a crescendo. While the EU looks at how best to move forward, innovation in the UK is benefiting from greater regulatory freedoms.

Top Stories EU

During the month of September, there were high-level calls for support for innovation in the EU, in the form of a white paper from Germany industry associations, an open letter from a total of 35 associations in the EU and discussions at the International Medical Device Regulators Forum, held in Berlin late in the month.

For several years now, there have been an increasing number of reports of manufacturers choosing to launch their new products in the US or other mature markets, instead of the...

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More from Europe

Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

More from Geography

German Bionic Launches ‘Strongest Exoskeleton To Date’

 
• By Natasha Barrow

German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.

India-UK Free Trade Agreement Sets Stage For Medtech Growth, But Industry Demands Safeguards

 
• By Shubham Singh

Announced after three years of negotiation, the FTA eliminates tariffs on 99% of Indian product types, covering nearly all trade value, and reduces tariffs on 90% of UK products. Although not yet formally signed, the deal is being positioned by the Indian government as “transformative,” with an estimated economic impact of $6.4bn for the UK alone by 2040.

Pathogen Sharing System Part Of Global Pandemic Agreement

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.