Medical devices: the shift from embedded to connected

Europe – Medical devices: the shift from embedded to connected

Software architects in the medical device industry have never had it easy. Delivering innovation within a rigorous regulatory environment is no mean feat. This...
SCCS - Final version of the Addendum to the scientific Opinion SCCS/1491/12 on the hair dye substance 2-Methoxy-methyl-p-phenylenediamine and its sulfate salt - COLIPA n° A160 - Submission II (use on eyelashes)

Europe – EUDAMED : Draft Functional specifications

Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices were published in the OJ on 5 April...
SCCS - Final version of the Addendum to the scientific Opinion SCCS/1491/12 on the hair dye substance 2-Methoxy-methyl-p-phenylenediamine and its sulfate salt - COLIPA n° A160 - Submission II (use on eyelashes)

Europe – Première version des spécifications communes pour consultation publique des Etats membres de...

  http://www.ris.world/wp-content/uploads/2019/03/ACT-IR-Annex-XVI-devices.pdf http://www.ris.world/wp-content/uploads/2019/03/ANNEXES-IR-Annex-XVI-devices.pdf  
Guidelines For Mobile Health Applications – Examining The Xcertia Guidelines' Initial Release

USA – Guidelines For Mobile Health Applications – Examining The Xcertia Guidelines’ Initial Release

Xcertia — an mHealth app collaborative founded by the American Medical Association (AMA), American Heart Association (AHA), DHX Group, and Healthcare Information and Management...
Is your software a medical device?

International – Is your software a medical device?

Computer software used in healthcare device applications developed for demographic data gathering, physical examinations or therapies are increasingly part of the regulatory landscape. This...
Italian medical device nomenclature to be adapted for Eudamed database

Italy – Italian medical device nomenclature to be adapted for Eudamed database

The European Medical Device Coordination Group (MDCG) plans to use Italy’s CND codes as the basis for the Eudamed device database nomenclature. CND...
TGA Proposes 5 Medical Device Classifications in Line With EU MDR

Australia – TGA Proposes 5 Medical Device Classifications in Line With EU MDR

In five separate consultations opened on Wednesday, Australia’s Therapeutic Goods Administration (TGA) proposed new medical device classifications in line with the EU medical device...
MDIC Works to Standardize Oversight of NGS-based Assays

USA – MDIC Works to Standardize Oversight of NGS-based Assays

To advance the regulatory science of diagnostic testing and assay development, the Medical Device Innovation Consortium (MDIC) posted a new landscape analysis report Wednesday...
Brazil's ANVISA launching Notification pathway for low-risk medical devices and IVDs

Brazil – Brazil’s ANVISA launching Notification pathway for low-risk medical devices and IVDs

Brazilian regulators have published RDC 270/2019 establishing a notification pathway for Class I medical devices and IVDs Qualifying low-risk medical devices will not...
CDRH Classifies Respiratory Infection IVD, System for Neurological and Psychiatric Disorders

USA – FDA proposes exempting some flow cytometers from 510(k) requirements

The Food and Drug Administration (FDA or Agency) is announcing its intention to exempt certain flow cytometer instruments from premarket notification requirements, subject to...

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