New implant recommended by NICE for uveitis

UK – New implant recommended by NICE for uveitis

Alimera Sciences’ fluocinolone acetonide implant, also known as Iluvien, has been recognised by the National Institute of Health and Care Excellence (NICE) for the...
EU MDR/IVDR: MedTech Europe Looks to Tackle Implementation Delays

Europe – EU MDR/IVDR: MedTech Europe Looks to Tackle Implementation Delays

MedTech Europe outlined a 7-point plan to aid EU member states in implementing the medical device and in vitro diagnostic regulations’ (MDR/IVDR) new system with greater...
Another Notified Body Bows Out Ahead of EU MDR: 'Investment Too High’

Europe – Another Notified Body Bows Out Ahead of EU MDR: ‘Investment Too High’

Swiss notified body (NB) QS Zürich AG has decided that it will not pursue designation under the new EU medical devices regulation (MDR), although...
Real-World Data Collection – What Role Could Your Device Play?

International – Real-World Data Collection – What Role Could Your Device Play?

Doctors often ask their patients to follow specific instructions as part of their prescribed treatment and hope that they do so. However, physicians currently have...
EC Cautions on MDR/IVDR Impact on Device Availability

Europe – EC Cautions on MDR/IVDR Impact on Device Availability

In a factsheet posted Monday, the European Commission (EC) acknowledged that the EU’s medical device and in vitro diagnostic regulations (IVDR) “could have consequences for the...
LRQA winding down Notified Body services for Medical Devices and IVDs

UK – LRQA winding down Notified Body services for Medical Devices and IVDs

UK-based Notified Body Lloyd’s Register (LRQA) plans to withdraw European Notified Body (NB) services for medical device and IVD manufacturers later in 2019. The company announced it...
May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says

Europe – May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says

While acknowledging that the May 2020 deadline for the implementation of the new medical devices regulation (MDR) is a “significant challenge,” the European Commissioner...
Biggest Regulatory Challenge is Software Safety

UK – Biggest Regulatory Challenge is Software Safety

John Wilkinson, outgoing director of devices at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), answered Focus questions via email on everything from Brexit to...
May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says

Europe – EC Selects Four UDI Issuing Entities

The European Commission (EC) last week revealed that GS1, the Health Industry Business Communications Council (HIBCC), ICCBA and Informationsstelle für Arzneispezialitäten (IFA GmbH) will...
EU awards Active Implants a grant of around $6.8M

Europe – EU awards Active Implants a grant of around $6.8M

Israeli-US company Active Implants has won a grant under the European Union's Horizon 2020 program. The grant is for the development of a future meniscus implant adapted to...

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