Journal Articles related to Medtech

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.

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).

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.

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.