PUBLICATIONS

Spain – Notification of post-market studies to AEMPS

Since 2015 and the change of the regulation regarding clinical investigation in Spain, Post-Market study should be notified to AEMPS according to RD 1090/2015, Third additional provision, point 3. “The start of clinical research with medical devices bearing CE marking...

Endometriosis: diagnosis and management

This guideline covers diagnosing and managing endometriosis. It aims to raise awareness of the symptoms of endometriosis, and to provide clear advice on what action to take when women with signs and symptoms first present in healthcare settings. It also provides...

New Regulation in the Official Journal of the EU

New Medical Device Regulation (MDR) have been published in the Official Journal of the EU on May 5, 2017 The new regulation on Medical Devices (EU) 2017/745 was published on May 5 and will take effect from May 25, 2017. The transitional period will officially start...

New Medical Device and In Vitro Diagnostic

New Medical Device and In Vitro Diagnostic Medical Device Regulations (MDR & IVDR) have been published in the Official Journal of the EU on May 5, 2017 The new regulation on Medical Devices (EU) 2017/745 and on In Vitro Diagnostic Medical Devices (EU) 2017/746...

HAS Event

Amélioration de la qualité de vie des patients et accès à l’innovation : deux priorités dans les évaluations des dispositifs médicaux – 24 novembre 2017...

National Health Strategy

La ministre de la Santé, Agnès Buzyn, a lancé ce lundi une grande concertation autour de la stratégie nationale de santé (SNS) qui sera adoptée en décembre par décret et fixera les priorités et les objectifs pour cinq ans. « L’objectif est de développer une...

SNITEM: 3 New Leaflets Published

A l’occasion des 5èmes Rencontres du Progrès Médical, le Syndicat National de l’Industrie des Technologies Médicales (SNITEM) annonce la parution de trois nouveaux livrets : la santé de la femme, la contactologie et les pathologies veino-lymphatiques. Véritable état...

A new era of data protection is beginning

“A new era of data protection is beginning. For medical device companies, compliance must begin promptly  in order to comply with the new Data Protection Regulations. The European Union’s General Data Protection Regulation (GDPR – 2016/679) was published on April 27,...

Loi Jarde

Latest DeviceMed publication  LOI JARDE – By Amélie Archer & Lucile Bernard – , MedPass International Link below AFCROs2 – Loi...

The Future Of Clinical Evidence Requirements For CE Marking

18 August 2015 Sarah Sorrel The Council of the EU’s agreed amendments to the requirements for clinical evaluation reports under the new Medical Device Regulation are substantial. And so are its proposed amendments to clinical investigations and post-market clinical...

The hospital market

 Pharmaceutiques magazine – The hospital market – Sylvia Germain EDAP TMS FRANCE (ULTRASONS FOCALISÉS DE HAUTE INTENSITÉ) Pierre Reboul, directeur EDAP TMS France : « Les lenteurs administratives et la T2A bloquent l’accès à l’innovation à l’hôpital. » «...