NEW GUIDELINES FOR CE MARKING
The recent regulatory developments concerning medical devices (MD) are becoming more binding. This is the logical consequence of the provision of more and more powerful devices but also more and more entangled with the modern and often complex therapeutic modalities, whether these modalities are invasive or non-invasive.
So far, with some exceptions, the marketing of medical devices was based on a European regulatory framework governed by 3 guidelines so called "new approach" that define the current principles of CE marking.
In this 'new approach', MDs1 other than AIMDs2 are divided into 4 classes: I, IIa, IIb and III according to their risk level, which is namely defined by the invasive nature of the MD, its type of invasiveness and the part of the body with which it is in contact.
However, the new 2007/47/EC guideline, applied since March 20, 2010, insists on the need for the sponsor to provide clinical data defining the effectiveness / risk ratio.
Therefore, IAMDs but also Class III devices likely to carry a "very serious risk potential", have to be subjected to clinical studies, the objectives of which are to outline these risks.
In all cases, even if the elements of request for exemption of a clinical study are met with, the clinical component of the CE marking application has to be systematically documented.
COMPULSORY CLINICAL ASPECT
The need to provide clinical data for MD, AIMD and IVDMD has therefore strengthened.
The clinical evaluation is expressed in terms of risk / benefit ratio.
In a lot of cases, it is also suitable to associate a study on the medico-economic impact of the DM.
Therefore, in order to save time, it is essential to include right from the start elements that will help to demonstrate the clinical benefit rendered by the device as well as its marketplace in the overall therapeutic strategy.
The methodological choice here is essential and the Bayesian approach particularly suited.
ICTA'S CLINICAL FULL-SERVICE ALL ALONG THE MEDICAL DEVICE LIFE SPAN
ICTA offers to support you with your specific issues throughout the setting up of your clinical studies (interventional or non-interventional studies, pharmaco-economic studies).
Within this scope, ICTA offers you a full-service with a comprehensive range of services in compliance with ISO 14155.
AIMD: Implantable Active Medical Device
IVDMD: In Vitro Diagnostic Medical Device