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The Implant Files: EU Blamed For Regulatory Inadequacies The World Over While 'Wrath'-Behrendt Fumes

 
• By Amanda Maxwell

All over the world, the medtech industry woke up Monday morning to read highly critical reports of the way the medtech industry is regulated. Investigative pieces accuse the medtech industry of putting profits before safety, of sabotaging the EU's best efforts toward more appropriate regulation, and treating patients as guinea pigs. This is a first look at the International Consortium of Investigative Journalists' Implant Files investigation from an EU perspective. 

Business concept illustration of a businessman being guided by a hand holding a flashlight uncovering arrow sign.

On Nov. 25, the International Consortium of Investigative Journalists (ICIJ) began unleashing the conclusions of a yearlong massive investigation into the medtech industry on a scale far exceeding anything carried out before – with a battery of further reports due over the coming week. The initial news was picked up all over the world by media outlets.

The main point that ICIJ is making is that patient safety is being compromised in countries throughout the world, with insufficient tracking of adverse events and recalls, and companies putting...

Global Safety Database

To increase transparency and to provide information around the world where such information is scarce, ICIJ has built the world’s only publicly searchable global database of recalls and...

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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.