The MDD is a complex document which outlines the essential requirements, classification rules and conformity routes for assessment of medical devices. Determining the specifics related to your device requires an understanding of the MDD’s 23 articles, dozen annexes and 18 classification rules.
The assessment criteria and requirements depend on the risk level and complexity of the device, so manufacturers must determine whether their device is covered by the MDD or another directive (for example, the Active Implantable Medical Device Directive).
Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit certain types of reports for adverse events and product problems to the FDA about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.
Medical Device Reporting (MDR) is one of the post market surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products
The European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), originally published on 05 May 2017 by the EU Parliament, sets forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU.
ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical.
Healthcare Organization Platform for Entry Level Certification (HOPE) is a revision of NABH’s current certification process for entry level HCOs/SHCOs, successful completion of which will ensure quality assurance of HCOs and SHCOs across the nation and will allow them to be eligible for NABH accreditation.
HOPE’s web portal has been designed to pave way for hassle free and convenient online documentation, an enhanced method of assessment as compared to the traditional model of manual submission of documents and evidences by the HCOs/SHCOs.