Taking a Deeper Look at Device Certification and Recertification

This article will outline a three-step approach to identifying your products with the highest commercial value, helping you prioritize your medical and IVD devices for compliance with the new MDR and IVDR. Internal assessment First, manufacturers need to inventory their entire pipeline and portfolio to determine the category for each product. At the same time, they need to note which devices have been newly classified as medical devices, such as disinfection and sterilization products, or up classified as Class III medical devices, such as surgical meshes and joint replacements. New additions to the IVDR are genetic tests and companion diagnostics that predict treatment response or individual patient reactions. The investment will vary greatly among products, from a standard regulatory submission to the need for clinical trials with patient data. Ask yourself which ones are worth carrying forward, based on the difference between additional compliance costs and future revenue potential. Take into consideration that payers may prefer devices certified under the new rules. In some cases, it may be more cost effective to renew certain products under existing directives, then discontinue them when their certificates are voided in 2024. Review how you will meet the increased data collection and reporting requirements, such as post-market surveillance, under MDR and IVDR. Then create gap assessment and closure plans, with the future steps you will take to be in compliance with the n...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news