MDR Vs Iso 14155
MDR Vs Iso 14155
MDR Vs Iso 14155
1
Clinical Investigations MDR Vs 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
Clause 6.4
SAE / deficiency reporting Article 80 MEDDEV 2.7.3
2
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