The Competitiveness and Communications Ministry, through the Consumer and Industrial Goods Directorate (CIGD) of the Malta Standards Authority (MSA), has drafted a set of amendment regulations to the Medical Devices Regulations, 2003 (L.N. 47 of 2003, as amended by L.N. 27 of 2004).

The proposed regulations transpose Commission Directive 2005/50/EC of 11 August, 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices.

Commission Directive 2005/50/EC requires EU Member States to reclassify hip, knee and shoulder implants from medium-high risk classification (Class IIb) into the highest risk classification (Class III) in Council Directive 93/42/EEC on medical devices.

Hip, knee and shoulder replacements present an increased risk of failure due to the particular complexity of the joint function to be restored.

In particular, total joint replacements are weight-bearing and extremely sophisticated implants, for which the risk of revision surgery is significantly greater than for other joints. Furthermore, such replacements are taking place on young people with high life expectancy and consequently the risks have increased.

The Medical Devices (Amendment) Regulations, 2007 will implement the requirement to reclassify hip, knee and shoulder replacements by introducing an amendment to the Medical Devices Regulations, 2003.

The effect is that classification of devices in Malta will be determined in accordance with the classification rules outlined in Schedule IX of the regulations, read in conjunction with Commission Decision 2005/50/EC, whereby hip, knee and joint replacements will be classified in Class III.