The CE mark is a legal designation that the manufacturer's product has met the requirements of all relevant Medical Device Directives in the EU. In order to receive the designation in a timely manner and meet your market deadlines, you need a partner that understands how to help you build reliability into your CE marking project planning - resulting in efficient certification and speed to market.
The CE marking is a kind of trade passport for the European marketplace: it allows the manufacturer to freely circulate their product throughout the 30 countries of the European Economic Area (EEA).
The great benefit for manufacturers is that there is now only one set of requirements and procedures to comply with in designing and manufacturing a product for the entire EEA.
The various and conflicting national regulations are eliminated. As a result, the product no longer needs to be adapted to the specific requirements of the different member states of the EEA.
In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims.
2-3 months from MHRA Uk for Class I.
We also deal in other classes, but time and cost can be quoted on the basis of instruments requirements.