Non CE marked medical devices /clinical investigation

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niksam

Studies involving non-CE marked medical devices carried out in the UK may be regulated as clinical investigations under the Medical Devices Regulations 2002 and require approval from the UK Competent Authority

1. Does invitrodiagnostic device follow this regulations
2. what does the term performance evaluation mean, i have been through 98/79/EC,but i am still not too clear
 
N

niksam

thanx chris for u r prompt response, i have been through the guidelines, our company is dealing with an IVD , of which two prototypes have been made and the device is under study at two centres[hospitals ], and its performance is compared with a gold standard method, so we are in the process to ce mark, for which categorisation is very vital, my question is will it fall under performance evaluation, then we could proceed with annex 8 for conformity
 
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