One of our customers in Denmark suggested that we should get the S’up spoon CE registered. For those that don’t know the letters “CE” are the abbreviation of French phrase “Conformité Européene” which literally means “European Conformity”. CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).
We thought this would be an excellent suggestion as we want everyone who buys or uses our spoon to know that they are buying a quality product that meets possible the highest quality standards.
Not having attempted to obtain a CE mark for a product before, we sought the help of a specialist company to help us through the process. As the spoon is designed to help people live more independently if they have shaky hands for any one of a number of reasons, we were advised that we should to apply for a CE mark for the spoon on the basis that it would be classified as a Class I Medical Device under the EU’s Medical Devices Directive (93/42/EEC).
We followed all the guidance we were given and completed a full risk assessment using the forms supplied by the consultants. We sent in our forms to the Medicines and Healthcare Products Regulatory Agency in London for approval explaining that the spoon people with shaky hands to eat food, and particularly liquids, more easily.
After considering our application they informed us that for the S’up spoon to be classified a medical device, a product must be intended to provide or assist with the diagnosis, monitoring, prevention or treatment of a medical condition. The MHRA said that this will not only depend on the device itself, but also on the claims made by the manufacturer for its intended use in the accompanying
The MHRA said that the spoon does not meet the definition of a Medical Device since it is not intended to provide or assist with the diagnosis, monitoring, prevention or treatment of a medical condition. This product would be considered an aid for daily living and there is therefore no need to register with MHRA and a CE mark under the Medical Devices Directive should not be applied.
The consultants recognised that they had given us incorrect advice initially and refunded us the fees they charged us. While we were frustrated by the incorrect advice we were given, we completed a full risk assessment for the S’up spoon which gives us confidence in the quality of the spoon we are producing.
