EU Commission adopts REACH nano changes

Europe – EU Commission adopts REACH nano changes

REACH is the over-arching legislation applicable to the manufacture, placing on the market and use of substances on their own, in preparations or in articles....
New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

UK – Notify MHRA about a clinical investigation for a medical device

Contents Christmas period 2018 How to notify MHRA of your clinical investigation In Vitro Diagnostic Medical Devices (IVDs) Special circumstances for healthcare establishments Heath...
Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR)

Europe – Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR)

European MDR clinical data requirements may result in up-classification or recertification of some medical devices. Manufacturers with CE Marked devices should be preparing...
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...
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...
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...
UK’s MHRA Offers 6 New No-Deal Brexit Guidances on Importing, Exporting Medicines

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...

NOS PROCHAINES FORMATIONS