Medical Devices - Expert Panels

Work of the Expert Panels

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The expert panels are designated in relevant medical fields to deliver opinions and views on the level of clinical evidence provided for certain high-risk medical devices and in vitro diagnostic medical devices. When needed, expert panels also give ad hoc advice to the European Commission, the Medical Device Coordination Group (MDCG), EU countries, along with manufacturers and notified bodies.

The roles of expert panels

Expert panels have a wide range of tasks, falling into 2 main categories

  • Opinions and views: in the context of conformity assessments of devices, expert panels respond to mandatory consultation procedures by notified bodies within the Clinical Evaluation Consultation Procedure (CECP) of certain high-risk medical devices and the Performance Evaluation Consultation Procedure (PECP) for certain in vitro diagnostic medical devices. Both require expert panels to assess key documents of the technical files for the devices falling under these procedures.
  • Ad hoc advice: in addition and depending on need, expert panels provide ad hoc advice to the European Commission, MDCG, Member States, notified bodies and manufacturers.

Initially the work of the expert panels will cover CECP and PECP functions, while the ad-hoc advice will be gradually phased in, depending on the requisite needs.

Who benefits from their expertise?

EU Commission and the MDCG: expert panels contribute to the development and maintenance of appropriate guidance and common specifications, to the development of standards at international level, contribute to the identification of concerns and emerging issues on the safety and performance of specific high-risk medical devices.

EU countries: expert panels provide advice in various fields upon request, including on the safety and performance of medical devices.

Notified bodies: expert panels provide opinions and views on certain high-risk medical devices and in vitro diagnostic medical devices, respectively. In addition, the panels may advise on the criteria for appropriate data set for the conformity assessment of medical devices.

Manufacturers: expert panels may provide advice with respect to manufacturer's intended clinical development strategy and proposals for clinical investigation.

The medical devices legislation details the tasks that the expert panels may be mandated to undertake. Please refer to Article 106 MDR for the full list of tasks.

Expert panels’ opinions

Certain high-risk medical devices, namely class III implantable devices and class IIb actives devices which are intended to administer and/or remove a medicinal product, will require the involvement of the expert panels. For these devices, a Clinical Evaluation Consultation Procedure (CECP) is needed, unless

  • there is renewal of certificate issued under the Regulation
  • there are relevant common specifications are available
  • there is a modification of a device already on the market, with certain conditions

High-risk devices that qualify for the procedure shall be assessed by the Screening panel, which will decide if an opinion by a thematic expert panel is needed. The following criteria shall be considered

  • the novelty of the device or of the clinical procedure involved have possible major clinical or health impacts
  • valid health concerns lead to a significant adverse change in the benefit/risk profile of a relevant category or group of devices
  • significant increase in the rate of serious incidents for a relevant category or group of devices

The Commission has provided specific guidance on the consistent interpretation of these criteria.

The expert panel members will base their opinion on documents received from notified bodies and manufacturers, besides their own expert knowledge and experience.

Expert panels’ views

Views produced by the expert panel on IVDs cover Performance Evaluation Consultation Procedures (PECP) for certain high-risk IVDs, where no common specifications are available and when it is the first certification of that type of device.

The expert panel members will base their opinion on documents received from notified bodies and manufacturers, besides their own expert knowledge and experience.

Expert panels’ positions

Expert panels may provide upon request ad hoc advice to the European Commission, MDCG, EU countries and notified bodies.