Clinical trials for cosmetic and aesthetic medical device products to support demonstration of conformity in accordance with EU MDR and ISO 14155 guidance. Medical device clinical investigations conducted by an experienced medical device clinical research organization

Clinical trials for medical devices are a necessity under the Medical Device Regulation (EU) 2017/745 (MDR) which places a stronger emphasis on the role of clinical evidence than previous published guidance. This Regulation covers applicable procedures for pre-market and post-market clinical investigation on medical devices and states that confirmation of conformity with relevant general safety and performance requirements shall be based on clinical data and manufacturers should provide a sufficient level of clinical evidence which is appropriate to the characteristics of the device and its intended purpose. The MDR medical device clinical study requirements incorporate Good Clinical Practice (GCP) recommendations, resulting in more detailed requirements.

Similar requirements and procedures for clinical trials with medical devices are described in the ISO14155 Clinical investigation of medical devices for human subjects – Good Clinical Practice (GCP) and in various European guidance documents related to clinical investigation. The ISO14155 guidance covers how to implement GCP for clinical investigations for human subjects to determine safety and performance of a device.

Design, conduct, recording and reporting of clinical trials - medical devices
Intertek is committed to supporting your medical device clinical research through the design and management of successful clinical investigations. Our clinical team, recruit human subjects, conduct studies, record and report clinical investigations to assess the clinical performance or effectiveness and safety of medical devices. Our clinical facility is in Paris and delivers clinical investigations under a clinical research agreement issued by the Health Ministry of France. We regularly welcome expert doctors and clinicians from all over the world to our Paris study centre as part of investigations.

Our dedicated internal recruitment team have the capability to recruit relevant and qualified subjects for your study. Following a review of our clinical investigation plan and design by regulatory authorities, our clinical research team which includes Project Managers, Clinical Research Associates, Quality Assurance team and expert clinicians (dermatologists, allergists, ophthalmologists, dentists, technicians, phlebologists, physicians), focus on protecting the safety and wellbeing of our human subjects.

Our experience and robust procedures, ensure the scientific conduct of the clinical investigation and the credibility of the results. We perform studies for both pre-market and post-market requirements including post-market clinical follow-up (PMCF) investigation for devices bearing CE marking. These clinical investigations are conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking.

Across a range of different medical devices including cosmetic and aesthetic devices, dermatology treatments (laser, peeling, filling products, preparations with soothing, healing and repairing properties, dressings, etc.), phlebology (e.g. compression stockings or strips) and ophthalmology (e.g. contact lenses), we follow well-defined and methodologically sound procedures based on a critical evaluation of the relevant clinical scientific literature and clinical trials medical devices guidelines relating to the safety, performance, design characteristics and intended purpose of the device.

Cosmetic and Aesthetic Medical Device Products
Cosmetic and aesthetic medical devices are now within the scope of the MDR (Annex XVI). This means that products such as coloured contact lenses, injectable dermal fillers, laser/intense pulsed light (IPL) hair removal equipment, skin resurfacing equipment and tattoo removal equipment will now have to comply with the new Regulation. Our team are experienced in the design and conducting clinical trials for dermal filler and other categories of cosmetic or aesthetic products.

Our medical device clinical trial design is supported by robust visual assessments and instrumental measurements. We regularly bring in new technologies and methodologies to obtain highly relevant data for each study. Visual Assessment include: skin radiance, fine lines visibility on the whole face and visibility of wrinkles on the whole face. These are typically graded on a 0-9 scale. Evaluation of Crow’s foot lines can also be determined by visual assessment and graded according to the Skin Aging Atlas, Volume 1, Roland Bazin, Eric Doublet, Skin firmness by touch

Instrumental measurements include:
• VISIA-CR® acquisitions
• Corneometry measurements
• Fringe projection with DermaTop®
• DUB®SkinScanner 75

Total Quality Assurance
Our mission is to provide our sponsors with the Total Quality clinical assurance. With Intertek as your trial Partner, we can accelerate your product development through scientifically credible medical device clinical investigations.
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