Is a declaration of conformity the same as a certificate of conformity?
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When it comes to medical equipment and products, a declaration of conformity (DoC) is an important document. This is a statement from the manufacturer that states that their product meets all the relevant safety and quality standards. A certificate of conformity (CoC) is a document that confirms the product has been successfully tested and meets the required standards.
In the UK, the declaration of conformity is not a legal requirement, but it is recommended. The certificate of conformity, on the other hand, is a legal requirement. If you are importing or selling medical equipment or products in the UK, you must have a CoC.
To get a CoC, the product must be tested in a recognised test laboratory. Once the product has been tested, the certificate will be issued. This document confirms that the product meets the requirements of the Medical Devices Regulations 2002.
The certificate of conformity is not just for products that are being sold in the UK. It is also for products that are being exported to other countries. If you are exporting medical equipment or products to the European Union, you must also hold a certificate of conformity that is in line with the Medical Devices Directive 93/42/EEC.
If you are not sure whether your product needs a certificate of conformity, you can contact the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is the body in the UK that regulates medical equipment and products.