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How Legacy Devices Can Remain On Market Once Former Certificates Have Expired

 
• By Amanda Maxwell

Published immediately after the 9 December meeting on the MDR at the Council of the EU, a new position paper explains a way forward for devices whose former MDD and AIMDD certificates are due to expire ahead of certification under the MDR.

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MDCG Document Sheds Light On How One Aspect Of European Commission Latest Proposals Will Work

A new EU position paper has been published which aims to promote a common understanding of, and a uniform approach to, the application of the Medical Device Regulation’s Article 97.

The full title is MDCG 2022-18: Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate

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More from Europe

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.

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

 
• By Amanda Maxwell

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 Ashley Yeo

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

 
• By Alaric DeArment

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

23andMe Purchase Will Let Regeneron Scale Drug Development

 
• By Alaric DeArment

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

 
• By Brian Bossetta

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.

Bringing Israeli Medical Device Candidates To The Right Partners In The US

 
• By Ashley Yeo

Despite regional unrest, it is business as usual for medtech innovators and investors in Israel as evidenced by continued high-value M&A of locally developed technologies. Irit Yaniv, co-chair of the medtech session at the upcoming BioMed Israel 2025, explained the unique dynamics of Israeli medtech innovation.