IVDR Advice for Experienced Manufacturers

Peter talks about how to deal with significant changes to products during the transition period, how to make OEM products ready for IVDR, how to streamline clinical performance evaluation and what to do with incomplete technical files. Remember:

• Prioritize products that will have significant changes to design or intended purpose.
• Have a quality assurance agreement in place with your OEM to determine who owns the technical documentation and start with a pilot project to establish procedures.
• Consolidating all your clinical or performance data into a performance evaluation report will help with ongoing updating during the product lifecycle (see Annex VIII 1.3.2).