Product portfolio and the new MDR

In order to CE-mark your devices against the Regulation, all the requirements will have to be met. There is no automatic acceptance of existing devices that are CE-marked against the existing Directive. Your portfolio of products needs to be reviewed against the new and revised requirements in order to determine the actions needed to change the CE-marking to the Regulation and the timing of that change. This includes products that are currently CE-marked under the Directives as well as those not currently requiring CE-marking because there are changes to the definition of a medical device that could affect your products. The changes to the definition of a medical device in the Medical Device Regulation mean that some products that were previously regulated under the Directive as accessories are now covered by the definition of a device, with the knock-on effect of products that were previously outside the scope of the Directive becoming accessories to what are now devices under the Regulation. For example, the definition now explicitly includes products specifically intended for cleaning, disinfecting or sterilizing medical devices, whereas these were previously considered accessories. Consequently, sterilization indicators that were previously outside the Directive can now be considered accessories to the sterilizing equipment (now considered a device) and are thus covered by the Regulation. However, the exclusion in the scope of the Regulation for products that contain or consist of living micro-organisms introduces a situation where biological indicators for sterilization could be considered excluded from the Regulation, but chemical indicators for sterilization considered as accessories. In addition, there is clarification that software in its own right, when intended to be used for medical purposes, is an active medical device, but software for general purposes (even when used in a healthcare setting, or software intended for lifestyle and wellbeing applications) are not devices.

Furthermore, certain products for aesthetic purposes are bought under the Medical Devices Regulation. The specific products affected are listed in Annex XV of the Regulation. One of the challenges of addressing aesthetic products that are not considered to have a medical purpose is the characterization of benefit versus risk. The Commission is charged with adopting common specifications that address the application of risk management and clinical evaluation of safety to these products. The Regulation applies to aesthetic products from the date that these common specifications are adopted.

A common specification is a document other than a standard that gives technical or clinical requirements providing a way to comply with the requirements of the Regulation. Common specifications have been introduced into the Medical Devices Regulation but were previously an element of the IVD Directive, where they were called common technical specifications. In general, manufacturers are obliged to comply with common specifications unless they can justify that they have adopted solutions ensuring a level of safety and performance that is at least equivalent, but, for aesthetic products, the applicable common specifications are mandatory. The status of standards that are listed in the Official Journal of the European Union, called harmonized standards, in providing a voluntary means to achieve a presumption of conformity with certain regulatory requirements has not changed in the Regulation from that in the Directives.

There are also changes in the classification rules that could affect your products under both the Medical Device and the In Vitro Diagnostic Medical Device Regulations. For Medical Devices, there are products for which the classification has increased or the oversight by the Notified Body has been heightened without an increase in classification. For example, surgical meshes, devices in contact with the spinal column (with some exceptions) and some substance-based devices are up-classified; additional Notified Body oversight is required for Class IIb implants and Class I reusable surgical instruments. For IVDs, a new classification system based on a set of rules has been introduced that will increase the classification for many products and the extent of Notified Body involvement.

One of the key areas that you will need to review is the clinical evidence that you have to support your device and whether that clinical evidence relies on demonstration of equivalence with a comparator device. You will have to be able to demonstrate that the device is equivalent to its comparator, based on scientific justification, in regard to:

• technical characteristics: device is similar in regards to design, specifications and properties, conditions of use, principles of operation and critical performance requirements;

• biological characteristics: device uses the same materials for a similar contact and with similar release properties; and

• clinical characteristics: device has the same clinical application at the same site in the body, in a similar population, with similar performance and with the same kind of user.

There needs to be no significant difference in the clinical performance and safety of your device and the comparator, and you have to be able to demonstrate that you have access to the data on the comparator device in order to justify that claimed equivalence. This is likely to restrict the use of equivalence to devices from the same manufacturer, unless there is an agreement in place allowing access to the necessary information on the comparator device. In June 2016, a revision of MedDev 2.7/1 Revision 46 on clinical evaluation was issued. Although this is guidance on the Medical Devices Directive, it provides a preview of some of the expectations in the Medical Devices Regulation. However, MedDev 2.7/1 Revision 4 and the Medical Devices Regulation diverge in some areas, so familiarity and knowledge of both, and in particular the differences between them, is important during the transition. Planning for compliance with MedDev 2.7/1 Revision 4 is likely to form a step in a comprehensive plan to come into compliance with the Medical Devices Regulation and drive the timeline for some activities.

Extract from the white paper: Planning for implementation of the European Union Medical Devices Regulations – Are you prepared?

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.