High-risk medical devices: consultation procedures and advice
Notified bodies must consult expert panels as part of the conformity assessment process for certain high-risk medical devices in the European Union (EU).
Medical devices
The medical device expert panels provide consistent scientific, technical or clinical advice in relation to the Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746).
They provide this to notified bodies, manufacturers, Member States and the European Commission.
Their mandatory role during the conformity assessment depends on the type of device:
- Medical devices
Expert panel reviews notified body's assessment of manufacturer’s clinical evaluation report - clinical evaluation consultation procedure (CECP)
- In vitro diagnostic devices
Expert panel reviews manufacturer's performance evaluation report prior to notified body's review - performance evaluation consultation procedure (PECP)
The legal basis for these activities is the Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746).
More information:
Also on this topic
- Medical device expert panels
- Class III implantable devices and Class IIb medical devices intended to administer or remove a medicinal product: expert panel opinions
- Class D in vitro diagnostic devices: expert panel views
- Medical devices: expert panel advice at the request of the Medical Device Coordination Group and the European Commission
Class III implantable devices and Class IIb active devices intended to administer or remove medicinal products
Notified bodies must consult an expert panel on their assessment of the manufacturer’s clinical evaluation report for the following types of high-risk medical device:
- Class III implantable devices (e.g. pacemakers, joint replacement devices, breast implants)
- Class IIb active devices that are intended to administer or remove medicinal products from the body (e.g. infusion pumps, ventillators)
Expert panel opinions are publicly available on this website:
This is known as the clinical evaluation consultation procedure (CECP). The legal basis is Article 54 of Regulation (EU) 2017/745.
To enhance the transparency on the work of the expert panels, the Agency is publishing the list of CECP opinions issued by the expert panels for medical devices undergoing conformity assessment. These CECP opinions will be made publicly available once the conformity assessment for the listed medical devices is finalised by the notified body, and the list updated accordingly.
Exemptions
Notified bodies are not required to consult an expert panel if one of the following applies:
- The device has already been certified under Regulation (EU) 2017/745 (i.e. renewals)
- The device has been modified from an already marketed device in a way that does not change its benefit-risk ratio
- Common specifications are available for the clinical evaluation of this type of device
Steps involved
Notified body checks if device is in scope
Device must be a Class III implantable device or a Class IIb active devices intended to administer or remove a medicinal product
Notified body considers if exemptions apply
Not required to consult expert panel if exemption applies
Phase I: Screening panel decides if opinion needed
Screening panel considers three criteria:
- Novelty of device and whether it is part of a clinical procedure with a potential major clinical or health impact
- Scientifically valid health concerns identified in the literature for the type of device, with regards to its components, source material, or health impact in case of device failure
- Significant increase of serious incident for the type of device that is relevant for the assessment
Guidance for the common interpretation of these criteria is available from the European Commission
If the screening panel decides not to provide an opinion, the notified body can go ahead with its usual certification procedures
Phase I takes 21 days
Phase II: Thematic expert panel provides non-binding opinion
Notified body should give due consideration to expert panel's opinion when taking its certification decision
Phase II takes 39 days after screening panel's decision
Class D in vitro diagnostic medical devices
Notified bodies must consult expert panels on the manufacturer's performance evaluation report (PER) for Class D in vitro diagnostic medical devices.
Expert panel views are publicly available on this website:
This is known as the performance evaluation consultation procedure (PECP). The legal basis is Article 48(6) of Regulation (EU) 2017/746.
Exemptions
Notified bodies are not required to consult an expert panel if one of the following exemptions apply:
- Common specifications are available for this type of device
- The type of device is already certified under Regulation (EU) 2017/746
Guidance to help notified bodies determine when to consult an expert panel is available from the Medical Device Coordination Group (MDCG):
Steps involved
Notified body checks if device is in scope
Device needs to fall under Class D
Notified body considers if exemptions apply
Not required to consult expert panel if exemption applies
In-vitro diagnostics expert panel provides non-binding view
Notified body should give due consideration to expert panel's views when taking its certification decision
Expert panel takes 60 days to provide a view
Advice
The expert panels may give ad hoc advice to the European Commission, the Medical Device Coordination Group (MDCG), national competent authorities in EU Member States, manufacturers, and notified bodies if needed.
In line with the Regulation, the expert panels may provide advice to the MDCG.
The implementation of these activities is gradual. EMA will provide further information when available.
All advice provided by the expert panels is publicly available on this website: