Gary Slack, Senior VP, Global Medical Devices at BSI said, “The regulatory landscape for medical devices is a rapidly changing one, and with that comes the transformation of Medical Device and IVD Regulation. We welcome the increased requirements under the two Regulations,...
It will be most important for the manufacturer to find a method to assess the risk class of the medical device correctly. 3.2. Data Analysis To begin with, a particular medical device must be categorized into one of the given groups, as specified in the new regulation. The selection of an...
The Medical Device Coordination Group (MDCG), which has many responsibilities in the new Regulation, has now been established. It is listed in the register of Commission expert groups as # X03565. Its mission includes “ensuring a harmonized implementation” of the new Regulations.>>> click he...
This chapter examines the robust growth in medical device regulation in China, which has accompanied the growth of the industry and the increasing level of medical technology approved for use in health care in China. It discusses the general procedures and requirements for pre-market approval and r...
A brief view of the standards and a detailed description of the most important regulatory bodies of developed countries, such as Food and Drug Administration, European Medical Device Regulation, China Food and Drug Administration, are given in this chapter. A general picture of Registration, ...
Medical device regulation is a controversial topic in both the United States and the European Union. Many physicians and innovators in the United States cite a restrictive US FDA regulatory process as the reason for earlier and more rapid clinical advances in Europe. The FDA approval process ...
Currently these certificates have a five year validity, which means that – depending on the life cycle of a device – a device will undergo repeated re-certifcation. This is somewhat of an anomaly internationally in the regulation of medical products. The international standard for medicines and...
In addition to the definition of a medical device, the European Union In vitro Diagnostic Regulation (EU IVDR),17an in vitro diagnostic (IVD) medical device is defined as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece ...
Medical Device Regulation mapping guide A guide to map your transition from MDD and AIMDD to the MDR By Royal Charter MDR mapping guide 2 Mapping to the MDR from MDD and AIMD This guide will help you to map the MDR General Safety and Performance Requirements (GSPR) to the Essential ...
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