Tout ce qu’il faut savoir sur les Biosimilaires

Europe – L’importance du niveau de preuve des données cliniques dans le RDM

Dans son article 61 (point 1), le Règlement UE 2017/745 énonce de façon laconique : « Le fabricant précise et justifie le niveau de...
Connected injection devices: Human Factors Challenges

USA – FDA wants public input on AI-enabled device regulation

The FDA today floated some ideas on how it might regulate medical devices armed with artificial intelligence — also known as software-as-a-medical-device (SaMD) — whose algorithms...
Des semelles connectées pour prédire le risque de chute chez des personnes âgées ostéoporotiques

France – Des semelles connectées pour prédire le risque de chute chez des personnes...

Cette étude clinique prospective a pour objectif d'identifier des marqueurs de risque de chute chez les patients souffrant d’ostéoporose. Elle sera conduite pendant 18...
Le temps presse pour les fabricants de DM de classe I

Europe – Le temps presse pour les fabricants de DM de classe I

Le règlement européen relatif aux dispositifs médicaux (RDM) vient renforcer les exigences en matière de classification, ce qui entraîne le passage de nombreux produits...
Chinese Regulators Revamp Innovative Medical Device Review Process

China – Chinese Regulators Revamp Innovative Medical Device Review Process

EMERGO SUMMARY OF KEY POINTS: The Chinese National Medical Products Administration (NMPA) has published revised requirements for its innovative medical device review program. NMPA...
Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR)

Europe – EU Lists First Notified Body Under MDR

BSI United Kingdom (UK) became the first notified body (NB) to be officially designated as an NB under the Europe Union’s (EU) medical device...
TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires

Australia – Medical device labelling obligations

This information explains the labelling requirements for medical devices to help manufacturers and sponsors meet their obligations. Labelling refers to labels and other information...
4 Key Usability Considerations For Biopharmaceutical Delivery Device Design

USA – 4 Key Usability Considerations For Biopharmaceutical Delivery Device Design

Often, the last thing on the minds of drug development teams working on a new generation of large-molecule biologics is the human factors engineering...
CLASSIFICATION DES DM : Comparaison DDM/RDM

Europe – Dutch MEB Hikes Some Medical Device Fees to Cover Rising Costs

The Dutch Medicines Evaluation Board (MEB) is hiking up the fees for some medical device services. MEB will now charge €9,000 ($10,000) for consultations...
UDI: 5 Opportunities You May Not Have Considered

USA – UDI: 5 Opportunities You May Not Have Considered

It may only be three letters, but for some manufacturers, UDI is a four-letter word. There are others who see the regulation as an...

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