DIRECTIVE 93/42/EEC CONCERNING MEDICAL DEVICES (THE MDD)20th Oct 2014
DIRECTIVE 93/42/EEC CONCERNING MEDICAL DEVICES (THE MDD)
If you are supplying weighing instruments that are used in the practice of medicine this is important.
The following clarification has been issued by the MHRA (Medicines and Health Care Regulatory Agency) regarding weighing instruments that are used in the practice of medicine.
If the manufacturer of a weighing scale only states that the scale is intended to provide a patient’s weight, with no other claims, then the scale does not need to be CE marked under the medical device regulations but will need to comply with the NAWI regulations. If the manufacturer of the weighing scale makes additional medical claims for the scale (for example that it calculates BMI or has additional ‘medical’ functions) then the medical device regulations would be likely to apply in addition to the NAWI regulations.
The effect of this is that if the weighing instrument only weighs, the Medical Devices Directive does not need to be referenced in the Declaration of Conformity. If there is more than one function, the instrument must comply with the MDD and compliance must be noted on the Declaration of Conformity. It should also be remembered that any instrument that the Medical Devices Directive applies to must also be registered with the MHRA.
If you would like further information on this please do not hesitate to give me a call.
Ian Turner, UK Weighing Federation