Early experience of the European Medical Devices Vigilance System.

The new European system for the regulation of medical devices is currently being introduced incrementally, having begun in 1993 with a view to completion around the turn of the century. Although still it its relative infancy there has already been valuable experience gained in relation to certain device types. The system is based upon three EC Directives; the first covering active implantable devices is now fully in force; with the second covering most other devices, currently within a transition phase. The Directives fully recognise the importance of stringent post market surveillance, one key element of which involves the reporting of certain device related incidents to and between the regulatory authorities of Member States (Competent Authorities). The objective behind the reporting requirements, or "Vigilance System", is to protect patients and other users by reducing the chance of the same types of incidents reoccurring in different places across the European Economic Area (EEA). As Competent Authority for the UK, the Medical Devices Agency was one of the first to put the System into effect and continues to play a leading role. In broad terms, Vigilance requires manufacturers to notify Competent Authorities of incidents, known as Vigilance Cases, in which a device led to or might have led to the death or serious injury of patients or users. In addition they must also provide similar notification of device recalls undertaken for a technical or medical reason. For their part, Competent Authorities are required to share certain details of Vigilance Cases between each other, and with the European Commission. While mandatory incident reporting is not a new concept outside Europe, Vigilance is unique in attempting to coordinate this across nineteen different countries with different languages and cultures. Even after four years, there remains some confusion among industry and regulators alike over exactly what is required and how best to achieve it. In particular there is an element of concern among manufacturers over apparent variations in interpretation being demonstrated by different Competent Authorities. Although derived from an inherently sensible and straight forward objective, in practice Vigilance raises a myriad of questions such as when, how and to whom should reports be made, and perhaps most fundamentally, exactly which incidents should be reported. The Directives themselves offer little clarification, and in recognition of this the Commission drew up the EC Guidelines on the Medical Devices Vigilance System. These Guidelines, while not legally binding offer practical and invaluable answers to these and many other important questions. Ongoing improvements to the Guidelines appear to be the best way to try to "level the playing field" across the EEA. Considerable effort continues to be made to fine tune this document with input representing regulatory and industry interests and it is hoped that a second revision may be available next year. Vigilance is gaining popularity as a model for adoption outside the EEA, particularly as it begins to overcome the operational hurdles characteristic of the first "live running" of any new system.