Clinical Investigations MDR Vs ISO 14155:2011

MDR EN ISO 14155:2011

Definitions Article 2 Clause 3 Articles

Responsibility of the Sponsor Article 62 (2) Clause 8 Vs
Ethical Considerations Article 62 (3) Clause 4 Clause
Ethics Committee Article 62 (3) Clause 4.5

Vulnerable Populations Article 62 (4) Clause 4.6

Informed Article 62 (5) Clause 4.7

Consent EU.536.2014
Investigator Article 62 (6) Clause 9

Insurance Article 69 Clause 4

Regulatory Authority Article 70 Clause 6.1

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Clinical Investigations MDR Vs ISO 14155:2011

MDR EN ISO 14155:2011

Assessment by
Article 71 MEDDEV 2.7.2
Articles
Member States
Vs
Conduct of Investigation Article 72 Clause 6
Clause
Electronic System Article 73 EUDAMED

Devices with a CE Mark

(PMCF) Article 74 Clause 1

Modification to CIP Article 75 Clause 8.2

Communication between MS Article 76 EUDAMED

Suspension or Termination Article 77 Clause 7

Multi-site in different MS Article 78 EUDAMED

Clause 6.4
SAE / deficiency reporting Article 80 MEDDEV 2.7.3
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Clinical Investigations MDR Vs ISO 14155:2011
MDR EN ISO 14155:2011

Ethical
Considerations
Annex XV (I,1) Clause 4
Annex
Study Design Annex XV (I,2) Clause 5.3
Vs
Statistical Considerations Annex XV (I,2.4) Annex A Annex D Clause
Endpoints Annex XV (I,2.6) Clause 5.3

Training of those involved in the CI Annex XV (I,2.7) Clause 5, 6, 8

Application for CI Annex XV (II,1)

Investigator’s Annex XV (II,2) Clause 5.5

Brochure Annex B
Clinical Investigation Plan Annex XV (II,3) Annex A

Ethical Annex XV (I,1) Clause 4

Considerations
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Clinical Investigations MDR Vs ISO 14155:2011
MDR EN ISO 14155:2011

Statement from Person Responsible Annex XV (II,4.1)

for Regulatory Compliance Annex
Ethics Committee Opinion Annex XV (II,4.2) Clause 4.5 Vs
Indemnity Insurance Annex XV (II,4.3) Clause 4.4, 8 Clause
Patient Information Annex XV (II,4.4) Clause 4.7
& Consent
Data Protection & Annex XV (II,4.5) Clause 6.7
Confidentiality
Responsibility of the Sponsor Annex XV (III) Clause 8

Clinical Investigation Report Annex XV (III, 7) Clause 7.3 Annex D

Statement from Person Responsible Annex XV (II,4.1)

for Regulatory Compliance

Ethics Committee Opinion Annex XV (II,4.2) Clause 4.5

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