Sorry, finished this post without finishing.
How the classification works is that all equipment automatically starts on class 1, but manufacturers have to answer a serise of questions.
i.e. does device get used for channeling fluids into a body cavity if yes then Class 2b etc.
What class the equipment eventually gets classified determines how they get CE marking.
classification rules can be found on this link
http://www.medical-devices.gov.uk/mda/md...fd3//bull10.pdf i.e. if Class 1 then company can self certify assuming its QA has been passed by notified body. Only Class 1 devices which are sterile or perform a measuring function need Notified Body (ie BSI) approval and have the 4 digit number assigned by the CE mark. If it has self certified then the 4 digit number is absent. There are many ways of obtaining CE marking even within each class category (I think Class 2a has at least 2 routes). Below is the link on how to get CE marking according to risk category.
Hope this makes sense
http://www.medical-devices.gov.uk/mda/md...7fd3//bull4.pdf
