Journal Articles related to Medtech
Journal Article
Combination products are integral to the healthcare system and play an increasingly important role in patient safety and medicinal usability, enhancing therapeutic benefits and improving outcomes.
Journal Article
The concept of ‘vigilance’, as it applies to medical devices, relates to the identification, reporting and trending of serious incidents as well as any corrective actions related to safety. It is distinct but related to the supporting post-market surveillance processes which focus on the monitoring of information to provide periodic confirmation that the benefit of a medical device outweighs the risk. These are not new concepts, however the requirements for vigilance and postmarket surveillance were not clearly delineated or articulated within the original Medical Device Directive (MDD) or In Vitro Diagnostics Directive (IVDD).
Journal Article
As companies seek ways to bring their products to multiple markets, understanding those markets and their regulatory approval process is imperative. Choosing the most appropriate pathway can reduce the burden on both the sponsor and on the health authorities, and potentially expand access to more patients.
Journal Article
This article reviews the MEDDEV 2.7/1 Revision 4 requirements, with an emphasis on strategies to meet the individual requirements of specific regulators in one document. Key guidance on navigating the world of Clinical Evaluation Reports and the MEDDEV 2.7/1 Revision 4 are shared.
Journal Article
With thousands of outstanding conformity assessments for medical device certification under the Medical Device Regulation and limited capacity to manage these within the transition period, concerns over widespread product shortages in the EU market have been growing.
Journal Article
Manufacturers of medical devices must put in place a wide range of processes and documentation to meet post-market surveillance requirements. While this means more work, Belinda Dowsett of PharmaLex* explains that these requirements do give manufacturers better insight into the performance of their devices.