Draft Brexit Agreement’s Implications for Medical Device Sector

Europe – Draft Brexit Agreement’s Implications for Medical Device Sector

A draft agreement on Brexit has been struck between EU and UK negotiators. Notified Bodies will remain recognized during the transition period. It...
EC Reiterates: All Batch Testing Must be Transferred From UK to EU by 2020

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...
PredictSURE IBD gains CE mark, set for UK and EU launch

UK – PredictSURE IBD gains CE mark, set for UK and EU launch

Acquisition of the CE mark enables PredictImmune to market PredictSURE IBD, now the first validated biomarker based prognostic test in inflammatory disease, across the...
Application de diagnostic personnalisé pour le nouveau règlement européen

Europe – KPMG and RAPS: Medical Device Companies Under-prepared for European MDR

EMERGO SUMMARY OF KEY POINTS: A new medical device industry survey finds many firms still lack a firm understanding of the European Medical Devices...
‘Use greener asthma inhalers’, encourages NICE

UK – ‘Use greener asthma inhalers’, encourages NICE

The new decision aid includes a flowchart and multiple illustrated tables to help people with asthma, along side health professionals, to identify which inhalers...
RDM et RDMDIV : les fabricants dans l’attente des organismes notifiés

Europe – Is Progress on MDR and IVDR Happening Fast Enough?

One year into the transition periods for the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), experts within the industry...
Who's calling the shots in European healthcare?

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...
Medical devices: the shift from embedded to connected

UK – New NICE standards to improve digital health tech uptake

Multiple recent surveys, such as a Roche investigation that revealed 82% of ‘Generation Z’ want to see the NHS introduce digital solutions, are showing...
The Human Medicines and the Medical Devices Regulations 2019

Europe – Medical devices: EU regulations for MDR and IVDR

Overview This guidance provides information on the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR). Medical device types and their...
MHRA launches consultation on how to best engage patients and the public

UK – Virtual manufacturing of medical devices

Guidance for manufacturers who don’t design or manufacture devices but place their names on the product. Details All virtual manufacturers must now hold the full technical...

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