FDA Received 6,000 Reports About Essure in 2018

USA – FDA Received 6,000 Reports About Essure in 2018

FDA recently updated its Essure website to include an analysis of medical device reports received in 2018. The agency said it received about 6,000 medical...
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...
CDRH Drafts Guidance on Mouse Embryo Assays

USA – CDRH Drafts Guidance on Mouse Embryo Assays

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Wednesday called for comments on draft guidance to aid...
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...
Japanese firm develops assay with integrated circuit for cancer detection

Japan – Japanese firm develops assay with integrated circuit for cancer detection

Toray has developed an IC that can detect certain microRNA that occurs with cancer. Cancer cells  produce different kinds of microRNA which are specific to...
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...
UK NB Will Not Apply for EU MDR/IVDR

UK – UK NB Will Not Apply for EU MDR/IVDR

London-based Lloyd's Register Quality Assurance (LRQA) announced Wednesday that it will withdraw from its notified body (NB) services under the EU’s current medical device...
May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says

Europe – M2M Data Exchange Services Definition (v1 29 May 2019)

M2M Data Exchange available services for accessing MDR EUDAMED data available for Economic Operator (EO) organisations...
May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says

Europe – M2M data exchange services and entity models introduction (v1 29 May 2019)

This document assumes that readers are familiar with the EUDAMED MDR general propose and CEF eDelivery building block (EUSEND) of the Connecting Europe Facility...

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