According to Directive 93/42/EEC (MDD) all medical devices have to undergo a clinical evaluation in accordance with Annex X of the MDD. In vitro diagnostics (IVDs) are subject to a performance evaluation. We are here to help.
Clinical evaluation or clinical test?
The European Commission guideline MEDDEV 2.7/1 sets forth the clinical evaluation format. All data on a medical device’s performance and safety must be subject to critical evaluation. Clinical tests (trials) may be necessary in order to gather additional data to meet the criteria. These tests would have to be conducted in accordance with article 15 of the MDD and the standards outlined in ISO 14155
We support manufacturers actively when it comes to clinical evaluation and evaluating whether clinical tests (trials) are necessary. For combinations of medical devices and medicinal products, we also assist in questions regarding pharmacology.
IVDs are subject to a performance evaluation in accordance with Annex III of Directive 98/79/EC (IVDD). A clinical testing as part of a performance evaluation, may also be necessary for an IVD.
Medical devices are also subject to an evaluation of biocompatibility in accordance with ISO 10993 as part of the clinical evaluation. Diapharm works with qualified test laboratories to perform the necessary biocompatibility tests depending on the medical device’s risk class. We consult a toxicologist to verify test plans. The findings are summarised as part of a biocompatibility evaluation.