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IVDR Planning Resources

EU Compliance Countdown

IVDR Class D and IVDD List A or B

35
Months
6
Hours

Take the steps today to ensure your IVD product remains readily available throughout the EU marketplace.

The European Union’s (EU) and In Vitro Diagnostic Regulation (IVDR), originally published on 05 May 2017 by the EU Parliament, sets forth new and important requirements in vitro diagnostic (IVD) manufacturers that distribute products in the EU.

Increased regulatory oversight, expanded clinical evidence requirements, greater requirements for IVD manufacturers and intensified supervision of Notified Bodies are just some of the major changes to be considered as compared to the EU’s previous Directives, In Vitro Diagnostic Directive (IVDD).

NAMSA, in an effort to assist global IVD manufacturers with their compliance planning, has made available several complimentary resources which can be found below. We hope you find these tools to be beneficial as you prepare for the 26 May 2022 implementation date and beyond.

Get started with NAMSA’s Guide: How to Successfully Transition from IVDD to IVDR – a Roadmap of Priorities and Compliance Strategies 

 

Approved IVDR Notified Bodies
  • 3EC International a.s.
  • BSI Group The Netherlands B.V. (The Netherlands)
  • DEKRA Certification B.V. (The Netherlands)
  • DEKRA Certification GmbH (Germany)
  • GMED SAS (France)
  • TÜV Rheinland LGA Products GmbH (Germany)
  • TÜV SÜD Product Service GmbH (Germany)

Access this list by clicking here.

Webinars
Webinar
The Basics of IVDR Clinical Studies
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Webinar
IVDR Implementation: First Steps for Compliance for Products Already on the European Market
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Webinar
Ensuring your Post-Market Surveillance Process Meets the New ISO 14971:2019 Guidance and MDR/IVDR Requirements
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Webinar
How to Select the Right EU Notified Body for IVDR Compliance
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Webinar
IVD Clinical Trials: Essential Components for Product Launch in 2019 & Beyond
Learn More
Blog Posts
European Market , IVD
June 23, 2022
MDCG 2022-8: Clarification of IVDR Requirements for Legacy Devices
Christèle East, PhD
By: Christèle East, PhD
IVD , Medical Writing
June 16, 2022
MDCG 2022-2: Recommended Strategies for Data Retrieval and Literature Reviews
By: Lucile Ryckebusch
IVD
June 1, 2022
MDCG 2022-6: Transitional Provision Considerations for IVDR Conformity
By: Alex Laan
European Market , IVD , Regulatory
April 21, 2021
MDCG Publishes New Guidance on Use of Standards Under MDR/IVDR
Jane Arnold-Round
By: Jane Arnold-Round
European Market , IVD , Regulatory
November 24, 2020
New Guidance: Classification of IVD under the IVDR
By: Alex Laan
Clinical & Consulting , European Market , Regulatory
July 14, 2020
EU Commission Update : Notified Bodies Designated to MDR/IVDR
By: Adrian Keene
Clinical & Consulting , IVD , Regulatory
July 8, 2020
The IVDR Compliance Roadmap: From Start to Finish
By: Jonathan Ripley
European Market , Quality , Regulatory
December 30, 2019
Mapping QMS to EU IVDR Requirements: 3 Key Takeaways to Effectively Strategize QMS Implementation
By: Richard Bassett
European Market , IVD , Regulatory
November 18, 2019
Key Requirements of Post-Market Surveillance under IVDR
By: Warren Jameson
European Market , IVD , Regulatory
October 30, 2019
IVDR Technical Documentation: 5 Critical Parameters of Change You Must Understand
By: Warren Jameson
European Market , Quality , Regulatory
July 10, 2019
EU IVDR: Understanding the New QMS Requirements
By: Warren Jameson
European Market , Regulatory
March 20, 2019
Draft Corrigenda for EU MDR and IVDR Released
By: Adrian Keene
European Market , Regulatory
January 15, 2019
EU Commission Updates Website to Provide Additional MDR and IVDR Planning Resources
By: Adrian Keene
European Market , Regulatory
October 17, 2018
EU Commission & MDCG Release New MDR & IVDR Guidance Documents
By: Adrian Keene
European Market , Regulatory
July 26, 2018
EU Commission Issues Supplementary Guidance Information for CE Marks Under MDR & IVDR
By: Dr. Vincent Legay
European Market , Regulatory
September 19, 2017
UK MHRA Publishes Guide to the New EU Medical Device and IVD Regulations
By: Stephan Buttron
White Papers
White Paper
The EU In Vitro Diagnostic Regulation (IVDR): Clarification Regarding Commonly Asked Questions
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Guide
How to Successfully Transition from IVDD to IVDR: A Roadmap of Priorities and Compliance Strategies
Learn More
White Paper
EUDAMED Actor Registration Module: A Step Towards Greater Medical Device and IVD Product Safety and Transparency
Learn More
Guide
NAMSA Guide: In Vitro Diagnostic (IVDR) Readiness Guide
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Guide
NAMSA Guide: EU MDR & IVDR Regulation Tool
Learn More

NAMSA’s global IVD regulatory experts welcome the opportunity to discuss strategic options related to the new IVDR regulations, including the critical steps you should be taking now to realize successful outcomes.

Please contact us or visit our IVD webpage here to learn more about our services.

 

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