CE marking to the Medical Device Directive, 93/42/EEC is important if you manufacture or distribute medical devices within the European Economic Area.
The directive covers all products which claim to have a medical purpose and which are used in, and on, the human body, from heart valves to scalpels, excluding in vitro diagnostics, which are covered in a separate directive.
The exact definition of which products are covered can be found in the directive. However guidance on classification of your devices and which assessment route is most appropriate to meet your business needs is available directly from the LRQA Medical Device team.
Devices covered by the Medical Device Directive are grouped into four classes, according to the level of risk they present. The classification determines the choice of conformity assessment available to you.
- Class I - Low risk
- Class IIa - Medium – low risk
- Class IIb - Medium – high risk
- Class III - High risk
Your route to conformity
Under the Medical Device Directive, 93/42/EEC CE marking, LRQA is a notified body for using the quality system conformity routes - Annexes II, V and VI. You will need to complete a simple form letting us know about your company and your products. We will use this information to verify the requirements relating to your products and to work with you to determine the best options for conformity assessment including any other service we can help you with.
The Medical Device Directive, 93/42/EEC CE marking underwent review by the European Commission with the Amendment Regulations coming into force on 21 March 2010 as Directive – 2007/47/EC.
Need to know more?
Call 0800 783 2179 or download the detailed enquiry form in word format and email it back to us at firstname.lastname@example.org