The 1985 Act “A new approach to technical harmonisation” introduced the concept of “Essential Requirements” for a product’s safety and performance. This was considered to be a key enabler for establishing the single European market and has been a key component of all the product related Directives and Regulations which followed it, including those for Medical Devices.
This concept has not changed. Just as the current In Vitro Diagnostics Directive (IVDD) specifies the “essential requirements” for IVD devices in Annex I. So too the new EU In Vitro Diagnostics Regulation (EU IVDR) also specifies the essential requirements, and also in the new Annex I. However they have been renamed in the new EU IVDR as “GENERAL SAFETY AND PERFORMANCE REQUIREMENTS“.
Those familiar the current IVDD’s essential requirements, covering thirteen areas and divided into two chapters, will immediately see the similarities in the new EU IVDR Annex I. However, the new Annex I contains requirements covering twenty areas and is divided into three chapters.
While some of the changes simply represent a more logical naming or arrangement than in the IVDD; e.g. the requirements for labelling and instructions have been moved from Chapter II “…PERFORMANCE DESIGN AND MANUFACTURE” to a new Chapter III on “…INFORMATION SUPPLIED WITH THE DEVICE”. And quite a number of the requirements are defined in more detail than previously in the IVDD, there is very little that is really new in Annex I. For example; the requirements for risk management in Chapter I are described in much more detail than in the IVDD, but still in less than detail than in ISO14971. Similarly the requirements related to “Performance characteristics” are more specific and have been moved from Chapter I to Chapter II. Probably the most significant change is that the former requirements for devices for self testing now have a broader scope in that they also now alpply to devices for near-patient testing.
However, in summary, while the manufacturer’s Safety and Performance Requirements checklists will certainly be longer under the new EU IVDR compared to the Essential Requirements checklists of the IVDD. Plus of course, the amount of data required to demonstrate those requirements have been fulfilled will be increased as a result. The fundamental concept of the device having to fulfil certain specified safety and performance requirements, and the manufacturer having to be able to demonstrate that it does, is not significantly different in the new EU IVDR compared to the existing IVDD.