What changes will I see?
Firstly you will see no difference in the quality or performance of our products. The most visible change will be to the labeling of our products. This covers not only labels, but also instructions for use (including package inserts and specification sheets) and application notes. The biggest change is the use of symbols, these are based on harmonized standards such as EN 980 and ISO 15223. Examples are shown below and a list of symbols that you may see is shown overleaf.
Primary label
The Primary label is attached to individual reagent bottles and shows only symbols, these are explained in the accompanying instructions for use. The manufacturer is identified by the logo.
Secondary label
The Secondary label is affixed to product box and shows both symbols and the product name. Instructions for use.
Package inserts and specification sheets with explanation of symbols will be included with the product at manufacture. For some products, lot specific information can now be found on the secondary label rather than in the instructions for use.
Shipping Packaging. Note that there are some changes to shipping labels for care of the product in transit.
Frequently asked questions about the IVD Directive & the CE mark
Will this affect product supply? Inevitably there will be some assays discontinued by manufacturers if they are no longer commercially viable to produce due to the additional requirements for manufacture and quality assurance required by this Directive. The main impact will be for products classified to be of high or moderate risk. A full list of these products is given in Annex II of the Directive. No manufacturer will take the decision to withdraw a product lightly.
Could I be affected?
If you provide devices which meet the above definition outside your legal entity or provide a testing service for samples which come from outside your trust this Directive will affect you. MHRA have provided more information on who will be affected in a letter to the Chief Executive of NHS Trusts, a copy can be found on the MHRA website. http://www.medical-devices.gov.uk
What should I look for when buying an IVD to ensure it meets the regulations?
If you are purchasing a device for IVD applications you should ensure that it is CE marked according to the IVD Directive. Electrical equipment may bear a CE mark to show that it is compliant with the electromagnetic compatibility directive or the low voltage directive. If the product is being sold post Dec 7th 03 for diagnostic applications, it should be CE marked according to the IVD Directive. General laboratory equipment is excluded from the IVD Directive. If you are using products sold for general laboratory use for diagnostic applications you are effectively performing in-house manufacture and would need to validate accordingly. There are requirements for industry to sell devices appropriately as well as users to appropriately select devices for diagnostic applications.
What happens if I have IVD’s which are not CE marked Post 7th Dec 03?
Manufacturers are required to CE mark all devices placed on the Market after 7th Dec 03; however, products in the distribution chain can continue to be sold for a further 2 years so you may continue to see non CE marked devices post 2003.
What happens if I have a problem with a device? If you have a problem with an IVD product you should make a complaint in the normal way. The Directive requires manufacturers to have systems to handle complaints, to investigate them and feed the information back to develop better products and improve existing products.
If someone is killed or seriously hurt by a device the manufacturer is required to tell the local Competent Authority within 10 days for a death and 30 days for a near incident. Any such incidents should therefore be reported to the manufacturer so that they can see if any other devices could be affected and inform the Competent Authority. This should be conducted in tandem with the normal NHS reporting systems.
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