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...
This chapter provides the necessary definition and classification of a medical device, essential requirements, conformity assessment procedures, obligation of manufacturers (authorized representatives), and other information related to these issues.Access through your organization Check access to the full text...
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 ...
Medical Marcom LLC d/b/a “Medical Devices Group,” plus the “Medical Device Artificial Intelligence Institute” and “10x Medical Device” family of events (“MM” or “we”, “us”, “our”) provides this Web site (“site”) as a service to professionals in and serving the medical ...
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...
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 ...
According to "Medical Device Rules-2017" (MDR-2017), "Medical Devices (MDs) are the substances which are used for in-vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood, and blood component collection bag with or without anticoagulant and...
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...
establishing conformity with the recently publishedMedical Device Regulation (MDR). The SPRs are detailed in Annex I of the MDR. The SPRs have replaced the Essential Requirements (ERs) found in Annex I of each of the Medical Device Directive (MDD) and Active Implantable Medical Device Directive ...