E
esh14
Hi All,
I have a few questions regarding the Clinical Evaluation for an IVD medical device. Can anybody help me on the questions below?
1. Is MEDDEV 2.7.1 applicable for European Directive 98/79/EC (IVDD)?
2. Is there any other guidance document that we can refer to for Clinical Evaluation besides the SG5/N2R8:2007?
3. We intend to get CE marking for our IVD medical device.
a) In this case, can we adopt the CLSI standards in our validation protocols even though we are not going to sell our device to US market?
b) Is there any other harmonized standards or guidance document that we can refer to for our verification & validation protocols?
Much appreciated if someone could help me on this.
I have a few questions regarding the Clinical Evaluation for an IVD medical device. Can anybody help me on the questions below?
1. Is MEDDEV 2.7.1 applicable for European Directive 98/79/EC (IVDD)?
2. Is there any other guidance document that we can refer to for Clinical Evaluation besides the SG5/N2R8:2007?
3. We intend to get CE marking for our IVD medical device.
a) In this case, can we adopt the CLSI standards in our validation protocols even though we are not going to sell our device to US market?
b) Is there any other harmonized standards or guidance document that we can refer to for our verification & validation protocols?
Much appreciated if someone could help me on this.