RE: .10 May 2021 12:41
CE marking is not 'approved' per se, most organisations can self CE mark, but in medical devices the CE marking has to be completed by an ISO 13485 laboratory to approved testing standards, hence why we needed mologic. Once it has gone through that, you self mark the device and 'register' it with the MHRA. The material change happened today, when the CE marking was registered, hence the need for the RNS today....not when the MHRA say "yeah we've got it"