The Requirement of a Clinical Investigation
MDR Articles 62-82 and Annex XV cover the requirements of Clinical Investigations. Clinical investigations form part of the overall Clinical Evaluation of a device and are required for certain devices classes. Class III devices and Implantable devices require a Clinical Investigation – (with exceptions are per Article 61 (4) and (6) ) Clinical Literature Evaluation is required for all classes of devices under MDR, however, proving equivalence to another device is now much harder to establish under MDR and therefore, clinical evaluation of the literature as the sole source of clinical evidence is much harder to establish and so a Clinical Investigation may also be needed for Class IIa and IIb devices.Current MEDDEVs
The current MEDDEVs relevant to this area are:- 2.7/4 Guidelines on Clinical Investigations – A guide for manufacturers and Notified bodies
- 2.7/2 Guidelines for Competent Authorities– for making a Validation/Assessment of a Clinical Investigation Application
- 2.7/3 Guidelines for Medical Devices – Clinical Investigations; Serious Adverse Event Reporting
Introduction of a Sponsor:
Article 2 (49) Sponsor means ‘any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation’. Under MDR this means that investigators initiating clinical studies will be responsible for meeting MDR clinical study requirements.- Article 62 Legal representative must be appointed, who is responsible for ensuring compliance with sponsors obligations
- Annex XV New restrictions regarding appointment of a monitor who is independent of Investigational site
- Article 80 – inclusion of requirement for sponsor to report to all Member states in which clinical investigation is conducted, without delay ‘any serious adverse event that has a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible’
- Annex XV –policy regarding follow up and management of any deviations from the Clinical Investigational Plan at the investigational site and clear prohibition of the use of waivers from the Clinical Investigational plan