EU Commission Regulation on Electronic IFU of Medical Devices

EU Commission issued Regulation on Electronic IFU of Medical Devices (Nr. 207/2012) on 09 March 2012, a guidance cross-reference to directives AIMD 90/385/EEC and MDD 93/42/EEC.

A copy of the regulation can be downloaded here.

Outsourcing Medical Devices Production to China

There are over 5,000 medical device manufacturers in China, mainly producing Class I, Class IIa & Class IIb devices, as well as certain categories of IVD product. Class III players are few though the number keeps increasing. To outsource the production of Class I / II devices or IVD to a qualified OEM manufacturer in China could be a cost saving solution to many of the EU device manufacturers.

All the Chinese medical device manufacturers must be registered to and licenses by SFDA, therefore it is very easy to check if the Chinese enterprise who is willing to work with you is a real producer or simply a trader.

We would recommend EU medical device manufacturers who outsource the production to China, that the perusal of technical files is a crucial and essential step before you reach any agreement with the OEM supplier. Otherwise it could lead to the result of failure to obtaining CE marks for the devices in EU.

If you have the time and money, a third party audit to the OEM supplier in China is recommendable.

Or perhaps the deployment of a neutral buying agent shall be considered, to make sure that quality procedures are properly followed up. The agent shall not just pay regular visits to the OEM’s facility, but should also bear the knowledge of ISO 13485 & CE requirements in mind.