Livre blanc sur les rapports d’évaluation clinique dans l’industrie des DM

International – Livre blanc sur les rapports d’évaluation clinique dans l’industrie des DM

Cabinet de conseil en matière de réglementation et de conformité dans le secteur des sciences de la vie, Maetrics a publié un nouveau rapport...
New Report Compares FDA Quality System Requirements With ISO 13485:2016

USA – New Report Compares FDA Quality System Requirements With ISO 13485:2016

The Association for the Advancement of Medical Instrumentation (AAMI) this week released a technical information report to help the medical device industry prepare for...
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

Australia – Use of market authorisation evidence from comparable overseas regulators / assessment bodies...

The purpose of this document is to provide an overview of how specific overseas assessments and approvals can be used by applicants for the...
MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD

Europe – State of flux: European Notified Body numbers decrease further ahead of...

The European Notified Body (NB) landscape remains in uncertain territory as additional entities opt out of designation to the Medical Devices Regulation (MDR) and...
Trois nouvelles guidances du MDCG en Mars 2020

Europe – List of harmonised standards that the EC is asking CEN and CENELEC...

COMMISSION IMPLEMENTING DECISION of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards...
Contact Lenses: CDRH Drafts Guidance on Performance Criteria to Support 510(k)s

USA – FDA to End Alternative Summary Reporting for Devices

In the coming weeks, the US Food and Drug Administration (FDA) will sunset an alternative summary reporting program for medical devices, the agency announced...
Eudamed : un report de 2 ans à mettre à profit pour mieux se préparer au RDM

Europe – European Commission identifies which Eudamed data to be publicly accessible

European Commissioners have issued a new factsheet detailing types of information related to medical devices and IVD products to be accessible to the public...

Europe – Eudamed’s Delay and its Impact on Clinical Investigations Under the EU MDR

This article reviews possible ramifications caused by the delay in launching the European Union’s new electronic database, the European Database on Medical Devices (Eudamed).The...
Biologic and Biosimilar Misinformation: FDA Drafts Guidance

USA – Electronic Device Submissions: FDA Drafts Guidance

Thanks to the FDA Reauthorization Act of 2017 (FDARA), the US Food and Drug Administration (FDA) on Wednesday published a new draft guidance with “both...

USA – FDA Authorizes First COVID-19 Test Using Saliva Collected at Home

FDA has given the green light to Rutgers Clinical Genomics Laboratory for its COVID-19 laboratory developed test (LDT), which now offers the option of...

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