Tag Archive
The following is a list of all entries tagged with Medical Devices:
EMA, The European Drug Regulatory, Publish Draft Procedural Advice on the Consultation of Notified Bodies in Accordance with Article 9 of Regulation (EC) No.1394/2007
Filed in biotechnology,regulatory, August 24, 2010, 3:23 pmAdvanced Therapy Medicinal Products (ATMPs) are medicinal products for human use, including gene therapy, somatic cell therapy and tissue engineered products. ATMPs may incorporate, as an integral part of the product, one or more medical devices, in which case they are referred to as “Combined ATMPs” as defined in Article 2 of the Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products .
Drug Regulators, MHRA, Publish Guidance on the Vigilance System for CE-marked medical devices
Filed in devices,marketing, December 28, 2009, 10:20 amThis guidance document gives advice to manufacturers on the notification of adverse incidents involving implantable neurostimulators under the Medical Devices Vigilance System.
DeviceRegulators Publish Guidance Notice on Borderlines with Medical Devices
Filed in devices,regulatory, November 2, 2009, 5:40 pmMany manufacturers have difficulty in interpreting whether or not their product would be considered a medical device within the terms of the Medical Device Directive 93/42/EEC. This guidance document has been developed to aid with some of the more common areas of confusion
Apple Puts Onus of FDA Clearance on iPhone Developers
Filed in devices,regulatory, June 29, 2009, 12:38 pmAs more and more developers are make applications (apps) for the Apple iPhone, using at as in interface for medical devices is an obviouse solution and one that make alot of commercial sence
MHRA guidance on the vigilance systems for medical devices- Intraocular lenses
Filed in Uncategorized,devices,regulatory, June 22, 2009, 9:22 amThis guidance document gives advice to manufacturers on the notification of adverse incidents involving intra-ocular lenses under medical devices the chilling system. It includes, but is not limited to, the following types of intraocular lenses: posterior chamber; phakic; anterior chamber; multifocal; and accommodated. It is intended to facilitate uniform application implementation of the medical devices directive.
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