To be beneficial to patients, medical devices must be effective, with adequate clinical effect levels. At the same time, they should expose patients to the least possible risk. In addition to technical safety and performance, our clinical evaluation of medical devices must therefore be able to demonstrate clinical efficacy and effect size, burden and risks, and the reasonableness of the benefit / risk ratio through a clinical evaluation of your products. Clinical evaluation of a patient may also be required for clinical evaluation.
According to the new EU MDR, this proof of the clinical effectiveness of a medical device and of patient protection is generally provided by a clinical evaluator, namely by means of a specialist clinical evaluation of medical devices. We use proprietary, intelligent clinical evaluation tools . More often than before, a clinical trial according to EN ISO 14155 is required. At the same time, the manufacturer must submit a clinical development plan. A waiver of a clinical evaluation is usually intended only for non-critical products.
Tightened clinical requirements of the new Medical Devices Regulation of 2017 in six areas
The current clinical procedures for CE approval according to the German MPG and the European guidelines MDD / AIMDD / IVD expire in 2020. Old certificates will end no later than 2024. With regard to the clinical evaluation, the main differences between EU Directive 93/42 and EU Regulation 2017/745 can be found in the following areas: