Following our previous article on “New medical device Regulation 2017/745: Impact in nutrition field?”, it should have been time for the regulation to come into force. Indeed, the text should have been implemented on May 26, 2020, but due to the pandemic time, the transitional period will last one year more.
Let’s review the basics principles of medical devices products.
The Regulation 2017/745 seeks to more firmly frame Medical Devices (MDs) in order to guarantee a high level of quality and safety, with the aim of protecting the health of users. For this, Europe wishes to strengthen: the supervision of notified bodies (hence the fact that some will no longer be accredited), the conformity assessment procedures, the clinical investigations and clinical evaluation, the market vigilance and surveillance, and the transparency and traceability.
First, medical devices are products used for specific medical purposes, as for example the diagnosis, prevention, monitoring, treatment of disease or injury; or the investigation, replacement or modification of the anatomy or of a physiological or pathological process or state.
The second element of the definition is that MDs does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
Medical devices can be instrument, software, implant, material, substance, etc.
MDs are classified according to their inherent risks into classes I, IIa, IIb and III.
For scoring the risk, are taken into account: the duration of use (if the MDs are transient, used at short or long-term), if the device is invasive or active, and where the device will be located anatomically.
- Class I (lower risk degree): Represent noninvasive devices and reusable surgical instruments, such as wheelchairs, compression bands, compresses, glasses, crutches…
- Class IIa (moderate potential risk): Represent diagnostic tools, devices for conducting or storing blood, fluids or tissue, and invasive surgical devices such as contact lenses, skin clips, dental crowns, hearing aids, ultrasound scanners…
- Class IIb (high potential risk): Represent long-term surgical implants, contraceptive devices, active device intended to control the administration into the body of a biological liquid or of a potentially dangerous substance, such as hemodialyzers, infusion pumps, condoms, internal sutures…
- Class III (higher potential risk degree): Represent devices in contact with the central nervous system, the heart and the blood system, devices incorporating a substance which when used separately is considered to be medicinal, such as long-term or biodegradable surgical implants, active coronary stent, hip prosthesis…
CLINICAL EVALUATION AND CLINICAL INVESTIGATION
“The manufacturer shall specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements.” For this, the regulation suggests the following procedure:
(a) a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device;
(b) a critical evaluation of the results of all available clinical investigations; and
(c) a consideration of currently available alternative treatment options for that purpose, if any.”
It should be note that notified bodies are vigilant about the quality and integrity of the data provided into the clinical evaluation file.
Clinical investigations can be performed in order to provide specific clinical data for the MD when no data are available in the literature. Clinical investigations will be mandatory for classes III and the same level of requirement (and therefore methodological aspect of the design) will be required for all classes. In addition to the clinical evaluation file, clinical investigation can be performed in order to collect data during the Post Market Clinical Follow-up (PMCF).
Clinical investigations should be in line with well-established international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigation and Ethical Principles for Medical Research Involving Human Subjects.
Any specific request? Biofortis supports you to design your future studies in accordance with regulation requirements, please click here to contact directly our team!
– Hélène Chevallier, Clinical Methodologist, Biofortis Mérieux Nutrisciences –
Source: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices