• The EU European Commission have released new 9 guidance documents regarding new MDR and IVDR. 
• United Kingdom (MHRA) has published new guidance regarding Field Safety Notices (FSN)
• The EU European Commission have released a new version of 'Manual on Borderline and Classification'.
• Switzerland has released a notification for placing a medical device on the market according to Art.6 of the Medical Devices Ordinance
• Italy has issued two new documents, one for magnetic resonance standards, other for tender requirements
• France has released most updated databases regarding responsible persons and high risk devices.

• FDA Has Taken Steps to Strengthen The 510(k) Program  
• New notice about evaluation of automatic Class III designation 
• New 4 Guidance documents regarding IVD devices 
• USA has added new device classification rules into the CFR Title 21 and became effective   List of Changes Here
• Canada has published Draft Guidance Document for consultation- Licensing Requirements for Implantable Medical Devices Manufactured by 3D Printing

• Japan has issued an english edition of Japanese Medical Device Nomenclature (JMDN)
• India has published a new Guidance Document on Free Sale Certificate of Notified Medical Devices in India
• Australia has communicated a new consultation about the regulation of IVD companion diagnostics, reclassification of surgical mesh medical devices, and Updated guidance on market authorisation evidence 

• IMDRF has released new Guidance for Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices and Definitions for Personalized Medical Devices, and another for Optimizing Standards for Regulatory Use.

Updates: 

List of US FDA Recognized Consensus Standards Panel have been updated per FDA modifications. USA CFR Title Subchapter H has been updated following the CFR notifications. SEE ALL UPDATES

EU GDPR, Australia, and Canada

 Courses and Events updated with new content. Search or Open

 New article added regarding 3D Printing. Search or Open

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