If you plan to sell your medical devices in Europe, you must create and maintain a Clinical Evaluation Report (CER) that fulfils the requirements of the MDR .
Die klinische Bewertung umfasst die Beurteilung und Analyse klinischer Daten zu einem Medizinprodukt, um die klinische Sicherheit und Leistung des Produkts zu belegen. Ihr CER dokumentiert das Ergebnis der klinischen Bewertung Ihres Produkts.
Clinical evaluation reports are an important step on the way to CE marking oder bei bereits CE-gekennzeichneten Produkten, das legale Inverkehrbringen aufrecht zu erhalten. Viele Hersteller*innen haben Schwierigkeiten, die europäischen Anforderungen zu erfüllen. Im Audit gibt es dann nicht selten eine lange Abweichungsliste, da die Ansprüche an die klinische Bewertung in den letzten Jahren stetig gestiegen sind.
A compliant report should provide robust clinical evidence that your product fulfils its intended purpose without exposing users and patients to clinical risk. The report must be based on data drawn from your own studies and/or from clinical studies of other products.
Do devices that are already on the market have to demonstrate equivalence?
This depends on whether you are relying on clinical data generated on equivalent devices. If this is the case, the requirements for equivalence must be met and documented. This means that a written discussion must be held regarding the technical, biological and clinical comparability of the products. This also applies to products that are already CE-labelled, as the clinical evaluation must be updated and is subject to an ongoing process with the PMCF (Post Market Clinical Follow Up)in which clinical data must be regularly collected and evaluated.
How are manufacturers of simple and safe class I and IIa devices supposed to comply with the requirements if there is no clinical data for their product and/or there is no suitable or available literature?
Unless you are bringing something completely new to the market, in 99% of cases there is clinical data. The only question is the quality of this data, and this is where big differences really need to be made. Older study results often do not fulfil today's formal requirements for data collection or study design. Furthermore, there are many subtleties to consider because the study design of the equivalence product focussed elsewhere or the product structure differed in a clinically relevant part. Gaps in information usually have to be accepted here. These gaps must be filled with additional data.
It cannot be ruled out that the company's own clinical data will also have to be generated as part of a clinical study.
How do I approach the clinical evaluation systematically?
Firstly, it is important and also required to plan the clinical evaluation and to create a structured and comprehensive clinical evaluation plan before the actual data collection and evaluation.
The plan is the basis for all further activities. Of course, it first describes which product is to be evaluated and how the state-of-the-art is determined.
What medical environment am I working in? Is there a gold standard, are there alternative methods, etc.? Next, I plan how I will identify which data, clinical and non-clinical, as relevant data. Where do I research the data? I also determine how I will assess the data, i.e. how I intend to separate the wheat from the chaff, so to speak. In all of this, it is important to note that my criteria do not categorically reject data that may provide negative aspects.
The audit pays close attention to whether a product has been glossed over or whether it has actually been critically assessed.
What comes after the plan?
If the clinical evaluation plan is good, the next step is a lot of hard work and professional expertise. A lot of texts and data have to be viewed, evaluated, sorted and critically assessed. This is done by a team that can cover the entire spectrum of the product to be assessed.
It is therefore important to involve both suitable medical and technical experts in the work.
The bottom line is this:
The entire clinical evaluation process requires a high level of concentration and qualification for the task. As the author of a clinical evaluation, I have to understand, evaluate and recognise the mostly English specialist texts. The ability to work scientifically is a great help, if not indispensable. At the same time, I need to have a good understanding of formalities and be able to adhere strictly to defined processes. However, if the processes once defined turn out to be unsuitable, this must also be recognised
Aus unserer Sicht ist die klinische Bewertung das aktuell anspruchsvollste Dokument, das im Rahmen des Konformitätsbewertungsverfahrens für Medizinprodukte zu erstellen ist.
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More on the topic? Lesen unseren Beitrag zur klinischen Bewertung und medizinischen Nutzen.
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