Section I — Clinical evaluation consultation procedure (Article 54)
Source: MDCG-2020-01.pdf pages 25-28 (document: MDCG 2020-13)
Specific Considerations (scope of sections I–K)
Specific Considerations
Section I: Clinical evaluation consultation procedure for certain class III and class IIb devices (Article 54)
Is the procedure required by Article 54(1) to be applied? State Yes / No Provide further information where necessary with respect to this justification
If this procedure is not to be applied, with respect to Article 54(2) what is the reason?1
- (a) renewal of a certificate issued under the MDR;
- (b) the device has been designed by modifying a device already marketed by the same manufacturer for the same intended purpose, and the manufacturer has demonstrated to the satisfaction of the notified body that the modifications do not adversely affect the benefit-risk ratio of the device;
Provide a summary of the modification(s) that have been made to the device? Provide a summary of the manufacturer's rationale demonstrating that the benefit-risk ratio of the device is not adversely affected. Has the clinical data been provided to support the conclusions of the manufacturer regarding the benefit-risk of the modified device with respect to the previous version?
For legacy devices, verify:
- that the modifications do not adversely affect the benefit-risk ratio.
- that the device in question had a valid certificate under the Directives.
- in case the certificate has been withdrawn, suspended2 or expired, if there is an impact on compliance with the general safety and performance requirements, and
- that there is no pending assessment of changes for the device or outstanding non-compliance.
- the description of modifications provided and assess if these modifications are limited only to those needed in order to comply with the new legal requirements introduced by the MDR.
Note: limitations of the intended purpose of the device should not trigger the consultation procedure in accordance to Art. 54.
- (c) the principles of the clinical evaluation of the device type or category have been addressed in a CS referred to in Article 9 and the notified body confirms that the clinical evaluation of the manufacturer for this device is in compliance with the relevant CS for clinical evaluation of that kind of device.
Relevant scientific panel and associated competence area(s)
Indicate your opinion on the relevant scientific and associated competence area(s) for the device under assessment:
| Medical area(s) | Associated competence-related areas | ||
|---|---|---|---|
| - [ ] | Orthopaedics, traumatology, rehabilitation, rheumatology | - [ ] | Joint replacements (hip, knee, shoulder) |
| - [ ] | Spinal devices | ||
| - [ ] | Non-articulating devices, rehabilitation | ||
| - [ ] | Other | ||
| - [ ] | Circulatory system: cardiovascular / lymphatic system | - [ ] | Prosthetic heart valves and devices for heart valve repair |
| - [ ] | Cardiovascular stents (metallic and bioresorbable) and vascular prostheses | ||
| - [ ] | Active implantable cardiac devices and electrophysiological devices | ||
| - [ ] | Structural interventions and new devices (e.g. LAA/PFO occluders, heart failure devices) | ||
| - [ ] | Cardiac surgery including extracorporeal membrane oxygenation, cardiopulmonary bypass devices, artificial hearts (and left ventricular assist devices) | ||
| - [ ] | Other | ||
| - [ ] | Respiratory, anaesthesiology, intensive care | - [ ] | Respiratory and anaesthetic devices |
| - [ ] | Neurology | - [ ] | Central and peripheral nervous system devices |
| - [ ] | Implants for hearing and vision (sensory recovery) | ||
| - [ ] | Neurosurgical devices | ||
| - [ ] | Other | ||
| - [ ] | Endocrinology and diabetes | - [ ] | Endocrinology and diabetes (e.g. insulin delivery systems and closed-loop systems, continuous glucose monitoring) Implantable systems |
| - [ ] | General and plastic surgery, dentistry | - [ ] | Surgical implants and general surgery |
| - [ ] | Plastic surgery and wound care | ||
| - [ ] | Maxillofacial surgery | ||
| - [ ] | Dentistry (devices for dentistry (oral surgery, implantology, dental materials incl.)) | ||
| - [ ] | Other | ||
| - [ ] | Obstetrics & gynaecology including reproductive medicine | - [ ] | Devices for obstetrics and gynaecology |
| - [ ] | Gastroenterology & hepatology | - [ ] | Devices for gastroenterology and hepatology |
| - [ ] | Nephrology & urology | - [ ] | Devices for nephrology and urology |
| - [ ] | Ophthalmology | - [ ] | Devices for ophthalmology |
Provide further information necessary with respect to this justification
Conclusion for certain class III and IIb devices to be considered by the expert panel
Novel aspects See section C, subsection 'Novelty'
Benefit-risk determination See section H and the Overall Conclusion sections
Consistency of clinical evidence with intended purpose and PMCF Provide an assessment of the consistency of the clinical evidence with: (a) the intended purpose, including medical indication(s), (b) the post-market clinical follow-up (PMCF) plan.