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 and therefore just as the existing Medical Device Directive (MDD) specifies the essential requirements for medical devices in Annex I. So also the new EU Medical Device Regulation (EU MDR) also specifies the essential requirements, also in the new Annex I. However they have been renamed in the new EU MDR to “GENERAL SAFETY AND PERFORMANCE REQUIREMENTS“.
Those familiar the current MDD’s essential requirements covering thirteen areas and divided into two chapters, will immediately see the similarities in the new EU MDR Annex. However, the new Annex I now contains requirements covering twenty two areas and is now divided into three chapters.
While some of the additional requirements are simply the result of incorporating of the additional requirements for Active Implantable Medical Devices (AIMDs) – which were formerly in a separate Directive. And others are simply a more logical separation; the requirements for labelling and instructions have been moved from “DESIGN AND CONSTRUCTION” to the new third chapter on “Information” requirements. There are certainly both existing requirements which are defined in more detail compared to the current MDD, as well as some completely new requirements. For example; the requirements for risk management defined in chapter 1 are described in much more detail than in the MDD (although still less than detail than in ISO14971). As are the expanded requirements for devices incorporating materials of biological origin and the additional requirements for the contents of labels and instructions. Whereas the requirements for substances intended to be introduced into the human body were not present in the MDD, just to highlight a few examples.
In summary however, while the manufacturers requirements checklists will certainly be longer under the new EU MDR compared to the existing MDD, and 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 MDR when compared to the existing MDD.