Clinical evaluation procedure
Required clinical assessment of the medical device
The new EU MDR will apply from 26 May 2020. By 26 May 2020, for example, manufacturers will have to submit an EC certificate (declaration of conformity) after the new MDR, eg for the first time placing of medical devices on the market. The new EU regulations have the requirements for the burden of proof of safety and efficacy by means of clinical evaluation and if necessary. own clinical examination significantly increased. According to the new EU MDR, proof of the clinical effectiveness of a medical device and patient protection is provided without exception by means of a specialist clinical evaluation. The clinical evaluation of medical devices is part of the technical documentation of each medical device.
Equivalence and literature procedures
In many cases, the final clinical evaluation succeeds without clinical trial, by means of the equivalence and literature process.
For some medical devices, the clinical evaluation also includes a complex clinical trial .
Waiver of clinical data
A waiver of clinical data in the context of a clinical evaluation is usually intended only for absolutely non-critical products such as screws, wedges, plates and instruments.
The assessment includes evidence of the claimed clinical function, including the extent of clinical effect severity and associated patient efficacy. Notified bodies may also include further claims of the manufacturer in their examination, which may then also be clinically proven. Added to this is the analysis of risks and burdens.
Further clinical aspects may include, for example, hygiene requirements up to the sterilisability, biocompatibility, impermeability, strength or also the measuring accuracy of a product. There may also be questions of compatibility with other products, including third-party products, and testing of safety and operating instructions and training procedures for completeness and comprehensibility for healthcare professionals.
The evaluation is completed by the assessment of the reasonableness of the benefit / risk ratio. In this final balance of risk, burden and benefit, the benefits must clearly outweigh.
Our Clinical Equipoise Procedure without Clinical Examination
We are aware of the ethical imperative of avoiding, as far as possible, the burden of and risks to patients through clinical trials. The Clinical Equipoise procedure established at the Clinical Assessment Office, Prof. Zenner, may, in appropriate cases, allow the final question of the reasonableness of the benefit / risk ratio, after taking into account the patient's well-being, to be answered without a complex clinical trial. As a result, it may additionally succeed to represent economic latitudes of the manufacturer taking into account the patient's welfare.
For evaluation we use specific proprietary. Our benefit-risk analysis and assessment is based on the collection and review of data and literature. The clinical evaluation is basically based on clinical data. This data must already exist. Necessary data and literature selection are determined by the question of whether the medical device is novel or comparable to an already existing technology. They also depend on the status in the product life cycle of the medical device.
For existing data, our clinical evaluation is based primarily on data from recognized literature databases, FDA and BfArM notifications, or competitor data. As already required in the old MEDDEV 2.7 / 1, comparison products must be technically, biologically and clinically equivalent to an extent that there are no clinically relevant differences. For this, the manufacturers must provide the data of the reference product. In the case of class III and implantable devices, for example, the manufacturer must have the (foreign) devices and use them to generate the necessary data. Alternatively, he needs a contractually regulated access to the data and test results of the third-party manufacturer. Otherwise, the company will have to submit its own clinical results.
Assessment of the protection of users and third parties
The law protects not only the patient, but also users and third parties, which can mean more effort in the clinical risk assessment of medical devices.