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International -
Designing a Device for Drug Delivery? What You Need to Know about Extractables, Leachables, and Particles

Growing demand for drug-delivery devices is bringing the pharmaceutical and medical device industries closer together. The risks posed by particulates and extractables and leachables, for instance, present challenges for both industries, so drug-delivery device designers and their pharma partners are encouraged to take a risk-based approach to testing. Standards bodies and industry groups are already working on guidances to help, but much of the critical thinking is up to the manufacturers themselves...

Australia -
Medical devices notices & standards orders

Medical devices notices Therapeutic Goods (Articles that are not Medical Devices) Order No. 2 of 2017 (link is external) Declares that a material or other article that through chemical means is intended to change, or that acts by causing change to, the pH level of body fluids including in a body orifice, is not a medical device for the purposes of the Act Therapeutic Goods (Articles that are not Medical Devices) Order No.1 2017 (link is external) Declares that riboflavin products instilled into the eye(s) that are used in the treatment of disorders of the eye which cause structural changes...

India -
Introduces price controls for knee implants

India has capped prices of orthopaedic knee implants, in the country's latest move to bring down prices of medical devices. The introduction of price controls marks the latest step by Prime Minister Narendra Modi's government to make drugs and medical devices more affordable. In February, it imposed a 75 percent price cut for certain heart stents - wire mesh tubes used to treat blocked arteries, which caused protests among manufacturers...

Discovery -
MIT researchers developing device to pump drugs to the brain

Researchers at the Massachusetts Institute of Technology are developing a pump to deliver drugs directly to the brain. Alejandro Aponte, a mechanical engineering major at the University of Puerto Rico, has spent his summer working with Michael Cima, a professor of engineering, as part of MIT’s Summer Scholars program. The team’s pump prototype is attached to a needle, enabling targeted drug delivery. Aponte has focused his efforts on keeping the pump’s multiple parts as static as possible. ““That will be really important for when we want to make these smaller and implantable, because not only...

International -
Apple Continues Push Into Device Industry With New Patent Filing

Last week, tech behemoth Apple signaled its interest in further pursuing the development of new medical devices with a new patent granted for an electronic device that "computes health data." According to the patent , the device computes health data based on sensors and electrical contacts with one or more body parts of the user. The device, comprised of a camera, an ambient light sensor, a proximity sensor and a processing unit communicably coupled to the camera, offer a glimpse into ways the iPhone manufacturer may look to compete with medical device companies beyond its ResearchKit and...

Europe -
TÜV SÜD Extends Compliance Deadlines for State-of-the-Art Requirements of MEDDEV 2.7/1 Rev. 4

Requirements for demonstrating state of the art under MEDDEV 2.7/1 Rev. 4 are more specific than those in the current Medical Devices Directive (MDD) The MEDDEV is not legally binding TÜV SÜD has decided to extend implantation of requirements for demonstration of state of the art as specified in MEDDEV 2.7/1 Rev. 4 until the date of application of the Medical Devices Regulation...

International -
How to Navigate the Changing Device Manufacturing Landscape Through Financing

These are some of the biggest game changers in the medical device industry right now—and some lesser-known financing strategies that manufacturers can consider to prepare for continued growth. The medical device industry, and the healthcare industry as a whole, is poised for exponential growth in the coming years. Deloitte’s 2017 Global Health Care Sector Outlook points to a projected $8.7 trillion in global healthcare spending by the year 2020...

France -
Informations pratiques relatives au dépôt des dossiers et aux avenants

CHANGEMENT DES MODALITES DE DEPOT : les dossiers doivent être déposés uniquement par voie postale au secrétariat du CEPS (section des dispositifs médicaux, 14, avenue Duquesne 75 350 Paris cedex 07 SP). Guide pratique 2012 Téléchargement (115.2 ko) Ce guide contient la dernière version de la partie "identification de la demande" qui est identique à celle figurant dans le nouveau guide fabricant de la CNEDiMTS et le renvoi sur ce nouveau guide pour l’annexe 2b (dossier CNEDiMTS). Guide fabricant (dossier pour la CNEDiMTS)

Using Laser Marking to Meet UDI Requirements

Laser marking is an effective and safe solution for marking unique device identifiers directly onto medical devices. In 2013, FDA enacted a measure that requires most medical devices manufactured in the United States to carry a unique device identifier (UDI). This rule is intended to improve patient safety and increase accountability for manufacturers of medical devices in case of an adverse event. Laser marking is an effective and biocompatible method to keep manufacturers fully compliant with these new labeling requirements...

Qualifying Medical Device Development Tools: FDA Finalizes 2013 Guidance

The US Food and Drug Administration (FDA) on Wednesday finalized guidance first drafted in 2013 to formalize a program that qualifies medical device development tools (MDDT) for use in device development and evaluation programs...



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