MedTech Europe Warns Over ‘Untenable’ Transition to EU MDR/IVDR

Europe – MedTech Europe Warns Over ‘Untenable’ Transition to EU MDR/IVDR

MedTech Europe sent an open letter to the European Commission (EC) on Monday to urge immediate action on implementing the new medical device and...
Investigational site and personnel selection for medical device clinical studies

Europe – Investigational site and personnel selection for medical device clinical studies

European MDR requirements will affect criteria for medical device clinical study investigators and sites; Fewer clinicians will qualify as pre-clinical study investigators under...
EU Device Coordination Group Offers Eudamed Guidance

Europe – EU Device Coordination Group Offers Eudamed Guidance

The EU’s Medical Device Coordination Group (MDCG) on Monday released two new documents explaining how legacy devices can be registered in Eudamed without a...
RDM et RDMDIV : les fabricants dans l’attente des organismes notifiés

Europe – RDM et RDMDIV : les fabricants dans l’attente des organismes notifiés

En décembre dernier, Team-NB (association européenne des organismes notifiés pour les dispositifs médicaux) et NB-Med (groupe de travail de la Commission européenne) ont publié...
Pharmaceuticals: EU refines intellectual property rules

Europe – European Commission Says Majority of Drugs, Devices Compliant Ahead of Postponed Brexit

Just before the European Council decided, in agreement with the UK, to postpone Brexit until 31 October, the European Commission offered an optimistic report...
Pharmaceuticals: EU refines intellectual property rules

Europe – Préparation à un Brexit sans accord: la Commission européenne dresse le bilan...

Dans la perspective du Conseil européen (article 50) d'aujourd'hui, la Commission européenne a fait le point sur l'intense préparation de l'Union européenne à un...
Virtual manufacturing of medical devices

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...
‘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...
COCIR Pushes to Harmonize Device Standards

Europe – COCIR Pushes to Harmonize Device Standards

The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) issued a position paper on Tuesday to facilitate the harmonization of...
MedTech Europe Warns Over ‘Untenable’ Transition to EU MDR/IVDR

Europe – MedTech Europe Flags MDR/IVDR ‘Burning Points’

Notified body (NB) availability and readiness for implementation of the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) stand out among “burning points” in need...

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