CE marking to the Medical Device Directive 93/42/EEC is important if you manufacture or distribute medical devices within the European Economic Area as since 1998, it has been a regulatory requirement for medical devices offered for sale in Europe to have CE marking affixed.
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, LRQA is a Notified Body for medical devices 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 and then we will use this information to verify the requirements relating to your products and by working with you determine the best options for conformity assessment including any other service we can help you with.
Medical Device Directive Requirements
LRQA has been assessing to the MDD since 1994, and we hold Notified Body status for over 15 EC product directives. With nearly 20 years’ experience as a Notified Body, LRQA has established an in-depth knowledge of certification within the medical device sector and all the Medical Device Directive essential requirements. With our experience of QMS and CE marking, we can help ensure you meet the MDD requirements.
The two-stage certification process for CE marking ensures you have a quality system that follows the MDD guidelines and meets the MDD requirements of the conformity annex applied and is implemented for the manufacture of the medical device concerned.
Your LRQA assessor will establish that you have correctly identified which Medical Device Directive essential requirements apply to your products, have fully integrated the requirements into the QMS system and have taken the necessary steps to draw up the technical documentation. Once approved, LRQA will regularly review your system and sample your technical files to ensure you remain compliant with the MDD requirements through surveillance visits.
Find out more about the new Medical Device Regulation (MDR)
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