|As of 21 March 2010, a Single EEA European Authorised/Authorized Representative must be designated by a non-EEA manufacturer of medical devices as required by directive 2007/47/EC, are you ready?
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Steps for Class I medical devices compliance
- Classification: ensure the device is a Class I medical device.
- Choose Conformity Assessment Route: refer the flow chart below.
- Compile the Technical File.
- Declaration of Conformity.
- Appoint an Authorised Representative. (register with the Competent Authority)
- Vigilance and Post Market Surveillance. (affix CE marking & market the products)
Class I Medical Devices: Conformity Assessment Routes
The conformity assessment routes for Class I Medical Devices
- The manufacturer is responsible for ensuring that his product complies with all the
relevant Essential Requirements of the Directive and must draw up a written statement to
this effect (self-declaration).
- Class I Medical Device without a measuring function and supplied in non-sterile condition does NOT require the involvement of a Notified Body. Conformity to the International and European Standard EN ISO 13485 is voluntary.
- Manufacturers of sterile products and devices with a measuring function must apply to a Notified Body for certification of the aspects of
manufacture relating to sterility or metrology.
- Once the manufacturer is satisfied that his products meet all the relevant Essential Requirements, the manufacturer, or his European Authorised Representative if the manufacturer is located outside of EEA, must register with the Competent Authority (CA). He may then affix the CE marking on his products and place them on the EEA market.
FAQ/Q&A: Questions and Answers about CE Marking of Medical Devices
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