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...
Téléimagerie : guide de bonnes pratiques

France – Téléimagerie : guide de bonnes pratiques

La Ministre des solidarités et de la santé a saisi la Haute Autorité de santé (HAS) en vue « d’élaborer un guide sur le bon...
Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019

Australia – Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order...

Two key requirements of the conformity assessment procedures for medical devices are that a manufacturer must implement: a Quality Management System (QMS) for the...
Health Canada Consults on New Proposed Device Regulations

Canada – Health Canada Consults on New Proposed Device Regulations

Health Canada on Friday launched a public consultation soliciting feedback on a set of proposed regulations intended to provide the agency with better safety...
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...
Brazil’s ANVISA adjusts upcoming regulation for custom-made medical devices

Brazil – Brazil’s ANVISA adjusts upcoming regulation for custom-made medical devices

Brazilian medical device market regulator ANVISA recently discussed revisions to planned requirements for custom-made devices with Emergo by UL consultants prior to finalization and official publication...
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...

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