EU Medical Device Regulation (EU MDR) – Chapter 6 – Clinical Evaluation and Clinical Investigations

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Description:

This is a significant and exciting chapter introducing a life-cycle approach to ongoing CE Marking compliance; it is a process, not a project. One output of the clinical evaluation process is demonstrating clinical performance of the medical device, i.e. demonstrating that the device performs as intended and has benefit to patients. Clinical data in support of performance can come from many sources including: clinical literature, trials, usability, post-market clinical follow-up (PMCF), the state-of-the-art, and/or from “equivalent” devices.

Curriculum for this course:

Overview

Previous Module	1 min 01 secs
Module Introduction	1 min 31 secs
Learning Objectives for this Module	1 min 10 secs

Articles 61 – 62

Article 61 – Clinical Evaluation – Part 1	1 min 05 sec
Article 61 – Clinical Evaluation – Part 2	1 min 10 secs
Article 62 – General Requirements Regarding Clinical Investigations Conducted to Demonstrate Conformity of Devices – Part 1	1 min 05 secs
Article 62 – General Requirements Regarding Clinical Investigations Conducted to Demonstrate Conformity of Devices – Part 2	1 min 15 secs
Article 62 – General Requirements Regarding Clinical Investigations Conducted to Demonstrate Conformity of Devices – Part 3	1 min 07 secs

Articles 63 – 69

Article 63 – Informed Consent	1 min 12 secs
Article 64 – Clinical Investigations on Incapacitated Subjects	1 mins 29 secs
Article 65 – Clinical Investigations on Minors	1 min 21 secs
Article 66 – Clinical Investigations on Pregnant or Breastfeeding Women	1 min 25 secs
Article 67 – Additional National Measures	1 min 10 secs
Article 68 – Clinical Investigations in Emergency Situations – Part 1	1 min 09 secs
Article 68 – Clinical Investigations in Emergency Situations – Part 1	1 min 30 secs
Article 69 – Damage Compensation	1 min 11 secs

Articles 70 -79

Article 70 – Application for Clinical Investigations	58 secs
Article 71 – Assessment by Member States	1 min 20 secs
Article 72 – Conduct of a Clinical Investigation	1 min 01secs
Article 73 – Electronic System on Clinical Investigations	1 min 19 secs
Article 74 – Clinical Investigations Regarding Devices Bearing the CE Marking	1 min 14 secs
Article 75 – Substantial modifications to Clinical Investigations	1 min 18 secs
Article 76 – Corrective measures to be taken by Member States and Information Exchange Between Member States	1 min 22 secs
Article 77 – Information From the Sponsor at the End of a Clinical Investigation or in the Event of a Temporary Halt or Early Termination – Part 1	56 sec
Article 77 – Information From the Sponsor at the End of a Clinical Investigation or in the Event of a Temporary Halt or Early Termination – Part 2	1 min 30 secs
Article 78 – Coordinated Assessment Procedure for Clinical Investigations – Part 1	59 sec
Article 78 – Coordinated Assessment Procedure for Clinical Investigations – Part 2	1 min 19 secs
Article 79 – Review of Coordinated Assessment Procedure	57 sec

Articles 80 – 82

Article 80 – Recording and reporting of Adverse Events that Occur During Clinical Investigations	1 min 19 secs
Article 81 – Implementing Acts	1 min 02 secs
Article 82 – Requirements Regarding Other Clinical Investigations	1 min 10 secs

Conclusion

Final Assessment

Certification

Author:

Ian Nicholls

Director at Explic8

Ian is a Director with extensive knowledge and experience in the management, development, implementation, and operation of processes and systems within the pharmaceutical and medical device industries. His skill set includes: • EU MDR 2017-745 / 21 CFR 820 / ISO 13485 / ISO 9001.