The European Union’s In Vitro Diagnostic Medical Devices Regulation, or IVDR, became effective May 26, 2022. In this session, you’ll get a glimpse of what’s changed since implementation day, the latest guidance available, and ways to keep your IVDD to IVDR transition moving forward. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.

1. Regulatory Requirements
Quality, and your QMS
IVDR Updates:
Making Headway
Despite the Turbulence

2. 2
In this session
Transitional Provisions
(Article 110)
Adapting Your
Implementation
Post Implementation Path
Associated Audits
Key Dates

3. IVDR UPDATES: Making Headway Despite the Turbulence Joanne Lebrun, MDC Associates
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IVDR Implementation
May 26, 2022
KEY DATES AND EXTENSIONS
Transitional Provisions must be in place
Class A products must be registered as self certified
All new products must be CE Certified via IVDR
Parliamentary Extensions
Pre-Market Submission
(CE) Cert required via IVDR
CLASS D
CLASS C
CLASS B
May 26, 2025
May 26, 2026
May 26, 2027

4. IVDR UPDATES: Making Headway Despite the Turbulence Joanne Lebrun, MDC Associates
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TRANSITIONAL PROVISIONS (ARTICLE 110)
if
Your product complies with IVDD
and there are no significant changes
in the product design and/or intended purpose
then
UNTIL THE PARLIAMENTARY EXTENSION
IVDD Certificates are valid1
IVDD Self Certifications (now Class B) are valid2
1
(EU) 2017/746 states devices could be put into service no later than 26 May 2024 which was extended by the Parliamentary decision
2 (EU) 2017/746 states devices could be put into service no later than 26 May 2025 which was extended by the Parliamentary decision

5. IVDR UPDATES: Making Headway Despite the Turbulence Joanne Lebrun, MDC Associates
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TRANSITIONAL PROVISIONS (ARTICLE 110)
Post-Market Surveillance
PMPF and PSUR (Class C & D)
Market Surveillance
Vigilance and notification
Change Control and
Notification of Significant Changes
more
Update your QMS
Implement!

6. IVDR UPDATES: Making Headway Despite the Turbulence Joanne Lebrun, MDC Associates
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TRANSITIONAL PROVISIONS (ARTICLE 110)
Registration of Economic Operators & Devices
Assign BASIC UDI-DI (Basic UDI-DI vs UDI-DI)
Register via EUDAMED
EUDAMED SOP
Apply with Designated IVDR Notified Body
Anticipate lead-times for new CE Certificates
and IVDR compliance audits
Update your QMS
CONTINUED

7. IVDR UPDATES: Making Headway Despite the Turbulence Joanne Lebrun, MDC Associates
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IMPLICATIONS TO YOUR IMPLEMENTATION
GS&PR SOP – incorporate at Design Inputs
Technical Documentation SOP
PEP, PER PMPF, PMS, PSUR (Class C&D only)
Quality Manual
Labeling Control SOP
Translation of Labeling and Field Actions
New Procedures
& Documents
more

8. IVDR UPDATES: Making Headway Despite the Turbulence Joanne Lebrun, MDC Associates
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IMPLICATIONS TO YOUR IMPLEMENTATION
Purchasing Controls
Quality Agreements with Regulatory responsible
persons, distributors
UDI SOP (& EUDAMED SOP)
Management Review SOP
Internal Audit SOP
Record availability (via Bankruptcy/Dissolution)
New Procedures
& Documents
CONTINUED

9. IVDR UPDATES: Making Headway Despite the Turbulence Joanne Lebrun, MDC Associates
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POST IMPLEMENTATION PATH
Define the Market Life of all products (storage of records)
Draft your DoC – DO NOT SIGN
Update Technical Documentation
Update GS&PR
more

10. IVDR UPDATES: Making Headway Despite the Turbulence Joanne Lebrun, MDC Associates
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POST IMPLEMENTATION PATH
Complete PMS and PSUR
Compile PEP, PER, PMPF
Documented assignment of PRRC
Including Roles & Responsibilities
Upload IFUs to Website
Perform all Internal Audits (including IVDR)

11. IVDR UPDATES: Making Headway Despite the Turbulence Joanne Lebrun, MDC Associates
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POST IMPLEMENTATION PATH
Apply with Notified Body
Examine Codes @ IVDR Designation
Understand Assessors with skillsets (Codes)
Understand Technical Reviewers with skillsets (Codes)
Contract with only one Notified Body
Identify Product Roster
Update DoC and Labeling
DRAFT ONLY through Certification Process!
Update Technical Documentation

12. IVDR UPDATES: Making Headway Despite the Turbulence Joanne Lebrun, MDC Associates
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ASSOCIATED AUDITS
Grants QMS certification for:
IVDR - EU 2017 / 746 (5-years)
Unannounced Audits Required:
Technical documentation*
“For Cause” during TD review
NOTIFIED BODY
REGISTRAR
Grants QMS certification for:
ISO 13485:2016
MDSAP (US, CN, JP, AU, BR)
Unannounced Audits Possible:
Grade 4 or Grade 5 NCs
*
15 minutes to production floor!
Who will audit me?

13. IVDR UPDATES: Making Headway Despite the Turbulence Joanne Lebrun, MDC Associates
We’re here for you
Questions or need help?
joanne@mdcassoc.com
Joanne Lebrun, Vice President
MDC Associates, Inc.