Medtech Connect Episode 5: EU Horizontal Regulations And Digital Tech

In this episode of Medtech Connect, Medtech Insight senior regulatory writer Eliza Slawther interviews MedTech Europe’s digital lead Alexander Olbrechts about the interplay between EU medical device laws with proposed horizontal regulations that impact digital devices, such as the AI Act, the Data Act and the European Health Data Space. The importance of international harmonized standards, particularly for cybersecurity, is also discussed.

Medtech Connect
• Source: Citeline/Shutterstock

More from Europe

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

 
• By 

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.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By 

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

23andMe Purchase Will Let Regeneron Scale Drug Development

 

The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.

More from Geography

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By 

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

23andMe Purchase Will Let Regeneron Scale Drug Development

 

The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.

Disparities — Including Financials Shortcomings — Remain In Women’s Health, Execs Say

 

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.