Commission Implementing Decision under MDR: Expert panels

On 11 September 2019, the Official Journal of the European Union was updated with a new Implementing Decision adopted by the European Commission.

The Decision on the designation of expert panels, which were introduced by the new Regulations on Medical Devices to assist their implementation with scientific / technical / clinical advice and to assess higher-risk devices, will enter into force in less than a month (on the twentieth day after its publication).

Expert panels will be covering the below areas:

    • Orthopaedics, traumatology, rehabilitation, rheumatology;
    • Circulatory system;
    • Neurology;
    • Respiratory system, anaesthesiology, intensive care;
    • Endocrinology and diabetes;
    • General and plastic surgery and dentistry;
    • Obstetrics and gynaecology, including reproductive medicine;
    • Gastroenterology and hepatology;
    • Nephrology and urology;
    • Ophthalmology;
    • In-vitro diagnostic medical devices (IVD)
    • Clinical evaluation consultation procedure (Point (c) of Section 5.1 of Annex IX of MDR)

Following a public call of interest, advisors will be appointed to an expert panel – for a term of 3 years – based on their:

    1. Adequate and up-to-date clinical, scientific or technical expertise in the areas above;
    2. Independence, impartiality, objectivity and absence of conflict of interest as outlined in Article 107 of the MDR;
    3. Balanced geographical representation;

Advisors shall perform their tasks while respecting principles of independence, impartiality, objectivity, commitment and transparency, while protecting confidential information.

When adopting scientific opinions, expert panel shall reach a consensus – when possible; if only majority is attained, this shall be mentioned as well as the reasoning behind the divergent opinions.

It was also announced that Expert panels’ common rules of procedure, internal guidance and methodologies for their operation should be established by the coordination committee and be publicly accessible. We will keep you informed on our MDlaw News section!

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