Changes to Medical Devices Directive

Identifying new standards for medical devices is not an easy task as they are not identified as new in the list of the electrical standards included in the Medical Devices Directive. Companies involved in this sector need to keep a permanent eye on the list to check if any changes have occurred. Recent changes include: EN60601-1-6 (Medical electrical equipment) - wholly new part-standard that concerns safety and covers usability; the EN 60601-2-27 standard for electrocardiographic monitoring equipment has been upgraded; and a new amendment has been made (A2:2005) to EN60601-2-37, the existing standard on the safety of ultrasonic medical diagnostic and monitoring equipment.

After a break of four years, representatives of the major regulatory systems in the medical sector throughout the world met to discuss the creation of a common basis of technical specifications, of evaluation and test procedures and of supplier monitoring.

Thus the efforts to create global harmonisation in medical equipment standards have been revived with hopes for real progresses in the near future.