ISO 13485
Advisera Home
ISO 27001
NIS 2
ISO 9001
EU GDPR
ISO 14001
EU MDR
ISO 45001
ISO 13485
ISO 17025
IATF 16949
ISO 22301
AS9100
ISO 20000
ISO in General
Contact Us
Log in
Conformio
Training
Community
Partner Panel
Experta
Implement & Learn
Implementation Products
Conformio
ISO 27001 Compliance Software
Built by top industry experts to automate your compliance and lower overhead.
Learn more
ISO 13485 Documentation Toolkits
All Policies, Procedures, and Records
Our toolkits supply you with all of the documents required for ISO certification.
View all
Learning Products
ISO 13485 Training
Accredited Online Training by Top Experts
Our course and webinar library will help you gain the knowledge that you need for your certification.
View All
Conformio
Documentation Toolkits
Training
Resources
Resources
By Type
Articles
Webinars
Courses
White Papers
Templates & Tools
View All
Where to Start
ISO 27001
NIS 2
ISO 9001
EU GDPR
ISO 14001
EU MDR
ISO 45001
ISO 13485
ISO 17025
IATF 16949
ISO 22301
AS9100
ISO 20000
ISO in General
New
AI Tool
Experta: AI-Powered Knowledge Base
Try now
Other
Live Consultations
Consultant Directory
Community
Resources
For Consultants
About Us
ISO 13485 Expert
Kristina Zvonar Brkic
Lead ISO 13485 expert
About Advisera
Contact Us
Get Started
Full text of EU MDR (Medical Device Regulation)
[simple-social-share css="0"]
EU MDR Table of Contents
Chapter 1 (Art. 1 – 4)
Scope and definitions
Chapter 2 (Art. 5 – 24)
Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement
Chapter 3 (Art. 25 – 34)
Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices
Chapter 4 (Art. 35 – 50)
Notified bodies
Chapter 5 (Art. 51 – 60)
Classification and conformity assessment
Section 1 (Art. 51)
Classification
Section 2 (Art. 52 – 60)
Conformity assessment
Chapter 6 (Art. 61 – 82)
Clinical evaluation and clinical investigations
Chapter 7 (Art. 83 – 100)
Post-market surveillance, vigilance and market surveillance
Section 1 (Art. 83 – 86)
Post-market surveillance
Section 2 (Art. 87 – 92)
Vigilance
Section 3 (Art. 93 – 100)
Market surveillance
Chapter 8 (Art. 101 – 108)
Cooperation between member states, medical device coordination group, expert laboratories, expert panels and device registers
Chapter 9 (Art. 109 – 113)
Confidentiality, data protection, funding and penalties
Chapter 10 (Art. 114 – 123)
Final provisions
(Anx. 1 – 17)
Annexes
Source EUR-Lex:
https://eur-lex.europa.eu/
EU MDR
Chapter 7
Section 2
Section 2 –
Vigilance
Article 87
–
Reporting of serious incidents and field safety corrective actions
Article 88
–
Trend reporting
Article 89
–
Analysis of serious incidents and field safety corrective actions
Article 90
–
Analysis of vigilance data
Article 91
–
Implementing acts
Article 92
–
Electronic system on vigilance and on post-market surveillance
« Chapter 7 – Post-market ...
Article 87 – Reporting o... »
IMPLEMENT ISO 13485 & MDR
BY YOURSELF
SEE HOW IT WORKS
Optimized for
small and medium-sized
companies
Costs up to 80% less than using consultants
Expert consultations and unlimited email support available
Created by Advisera, the leading website for compliance
