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EU MDR & IVDR Regulation Planning Resources

The European Union’s (EU) Medical Device Regulation (MDR) entered into force on 25 May 2017, with 26 May 2021 as the date of application. Similarly, the In Vitro Diagnostic Regulation (IVDR) entered into force on 25 May 2017, with 26 May 2022 as the date of application. These regulations set forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU and replace the previous EU Directives: the Active Implantable Medical Devices Directive (AIMDD), Medical Device Directive (MDD) and In Vitro Diagnostic Directive (IVDD).

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 requirements.

These lengthy documents can be cumbersome to navigate, particularly when trying to understand how the new regulations compare to the previous directives—and more importantly, the critical steps that manufacturers should undertake to ensure conformity to MDR and IVDR.

At NAMSA, we understand the challenges and complexities of these transitions. Our team comprises former Notified Body staff and seasoned professionals with extensive experience in guiding manufacturers through the compliance journey. Your success is our mission, and your future in the European market is our priority.

 

IVDR

To place in vitro diagnostic products and maintain access to the European market, manufacturers must manage the change to obtain a CE marking for their product under the new In Vitro Diagnostic Regulation (IVDR).

NAMSA offers several complimentary resources, news, and services to assist global IVD manufacturers with compliance.

 

 

 

MDR

To place medical devices on the market in the EU, the legal manufacturer must comply with the requirements of the MDR. There are also specific responsibilities for importers and distributors of medical devices.

Complementary resources are provided below to assist global medical device manufacturers with their compliance planning. These tools are designed to help prepare for both the introduction of new devices, and transition of legacy devices to the new regulation.

 

Webinars
Webinar
Clinical Challenges under the EU MDR
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Webinar
MDR Clinical Evaluation Reports: Key Elements and Lessons Learned for Successful Compliance
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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
EU MDR Part 2: How to Approach Clinical Evidence Requirements with Clinical Management & Biostatistics
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Webinar
EU MDR Part 1: Current Opportunities & Challenges with Clinical Data-A NAMSA Panel Discussion
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Webinar
Impacts of the Updated ISO 14971 & Harmonization of MDR/FDA Rules on Risk Management
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Webinar
MDR 10.4.1: What Should we Really be Doing to be Prepared?
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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
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Webinar
EU MDR: General Safety & Performance Requirements for the Biocompatibility of Medical Devices
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Webinar
EU MDR 2017/745: Optimizing CERs within the Medical Device Lifecycle
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Webinar
Leveraging Post-Market Surveillance & Clinical Follow-Up Data to Support EU MDR Compliance
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Webinar
A Practical Guide to Writing Summaries of Safety and Clinical Performance
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Webinar
Telling Your Medical Device’s Story to Regulatory Agencies
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Webinar
4 Pillars of IVDR: Integrating Post-Market Surveillance, Risk Management, QMS & Performance Evaluation
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Webinar
The Basics of IVDR Clinical Studies
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Blog Posts
Clinical & Consulting , European Market , Regulatory
December 20, 2023
MDCG 2021-6 Rev 1: Clarifications on Clinical Investigations
By: Sara Finocchietti, MEng, PhD
European Market , Regulatory
December 4, 2023
MDCG 2022-11 Rev 1: Urgency for MDR and IVDR Compliance
By: Kevin Butcher
European Market , Regulatory
December 1, 2023
Five Reasons Not to Delay Your MDR Certification
Paul Risborough
By: Paul Risborough
IVD , Regulatory
November 21, 2023
Why IVD Developers Must Embrace the IVDR Transition Now
By: Warren R. Jameson, PhD
European Market , Regulatory
November 1, 2023
MDCG 2023-4: Medical Device Software (MDSW) – Hardware Combinations
Paul Risborough
By: Paul Risborough
European Market , Regulatory
June 22, 2023
UK Extends Transition Period for Medical Device and IVD Products in New Legislation
Jane Arnold-Round
By: Jane Arnold-Round
European Market , Regulatory
June 1, 2023
Reflecting on the Second Anniversary of the EU Medical Device Regulation
David Mandley
By: David Mandley, PhD
European Market , Regulatory
April 28, 2023
Just Released: Updated Transitional Arrangements for UKCA Process
By: Kevin Butcher
European Market , Regulatory
March 8, 2023
UK MHRA Advisory Group Publishes Proposals
By: Kevin Butcher
European Market , IVD , Regulatory
February 22, 2023
European Parliament to Amend MDR/IVDR Transitional Provisions
By: Dr. Rachel Gibbs, PhD, BSc
European Market , Regulatory
December 16, 2022
MDR Update: EPSCO Proposes Transition Improvements and EU Commission Issues MDCG 2022-18
By: Kevin Butcher
Clinical & Consulting , European Market , Regulatory
December 6, 2022
EU Commission Publishes MDR Implementing Regulation for Devices without Medical Purpose (Annex XVI)
Jane Arnold-Round
By: Jane Arnold-Round
European Market , Regulatory
September 1, 2022
MDCG 2022-14: Transition to the MDR and IVDR – Notified Body Capacity and Availability of Medical Devices and IVDs
By: Kevin Butcher
European Market , IVD , Regulatory
August 15, 2022
MDCG 2022-10: Interfaces between the Clinical Trial Regulation and IVDR
By: Alex Laan
European Market , IVD , Regulatory
July 21, 2022
MDCG 2022-3: Verification of Manufactured Class D IVDs in accordance to the IVDR—One Size Fits All?
By: Alex Laan
European Market , IVD , Regulatory
June 30, 2022
The New UK MHRA Medical Device Regulations: Impact to IVD Manufacturers
Christèle East, PhD
By: Christèle East, PhD
European Market , Regulatory
June 28, 2022
New UK MHRA Medical Devices Regulations Published
By: Kevin Butcher
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 , Regulatory
May 9, 2022
New MDCG 2022-5 Guidance on Borderline between Devices and Drugs under MDR
Jane Arnold-Round
By: Jane Arnold-Round
European Market , Regulatory
March 1, 2022
New MDCG 2022-4 Guidance Released
Sr. Regulatory Consultant
By: Thomas Miramond
European Market , Regulatory
January 20, 2022
New Implementing Regulation Released to Provide Guidance on Electronic Instructions for Use (eIFU) under MDR
David Mandley
By: David Mandley, PhD
European Market , Regulatory
January 13, 2022
European Commission Releases Further Harmonised Standards under EU MDR
David Mandley
By: David Mandley, PhD
Clinical & Consulting , European Market , Regulatory
May 25, 2021
May 26, 2021: Marking a Regulatory Milestone for EU Medical Device Manufacturers
By: Adrian Keene
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
Clinical & Consulting , European Market , IVD , Regulatory
September 9, 2020
UKCA: A Wait and Watch Approach?
By: Richard Bassett
Clinical & Consulting , IVD , Regulatory
July 8, 2020
The IVDR Compliance Roadmap: From Start to Finish
By: Jonathan Ripley
European Market , Regulatory
April 9, 2020
European Commission Mandate for EU Parliament Negotiations on MDR Delay: Clarification Regarding Article 120(3)
By: Matt Royle
European Market , Regulatory
April 3, 2020
EU Response to COVID-19 Pandemic: Proposal to Delay Date of MDR Application to May 2021 for Certain Provisions
By: Matt Royle
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 , Regulatory
November 27, 2019
MDR Update: Draft Corrigenda Published Outlining Positive Impact to Class I Manufacturers and Up-Classification Rules
By: Adrian Keene
European Market , IVD , Regulatory
November 18, 2019
Key Requirements of Post-Market Surveillance under IVDR
By: Warren R. Jameson, PhD
European Market , IVD , Regulatory
October 30, 2019
IVDR Technical Documentation: 5 Critical Parameters of Change You Must Understand
By: Warren R. Jameson, PhD
Clinical , European Market , Regulatory
October 2, 2019
MDCG Issues Guidance on Summary of Safety and Clinical Performance under the Medical Device Regulation (MDR)
By: Dr. Vincent Legay
European Market , Quality , Regulatory
July 10, 2019
EU IVDR: Understanding the New QMS Requirements
By: Warren R. Jameson, PhD
European Market , Regulatory
March 6, 2019
EMA Issues Q&A Regarding Impact of MDR, Article 117
By: Adrian Keene
European Market , Regulatory
January 10, 2019
Renewal Timelines Quickly Approaching for Medical Device Directive (MDD:M5) CE Mark Certificates
By: Stephan Buttron
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
April 24, 2018
CE Marking of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR
By: Stephan Buttron
European Market , Regulatory
July 26, 2017
EU MDR Poses Significant Changes for Importers and Distributors
By: Stephan Buttron
European Market , Regulatory
April 20, 2017
MDR Transition Timelines for Legacy Medical Devices – Not without Risks and Undue Burden
By: Anney Peterson
White Papers
White Paper
Expanding your Market: Submitting U.S. EUA COVID-19 Products for EU IVDR Compliance
Learn More
White Paper
The EU In Vitro Diagnostic Regulation (IVDR): Clarification Regarding Commonly Asked Questions
Learn More
Guide
IVDD to IVDR: How to Successfully Make the Transition
Learn More
White Paper
EUDAMED Actor Registration Module: A Step Towards Greater Medical Device and IVD Product Safety and Transparency
Learn More
White Paper
Risk Management Systems: Implications of ISO 14971, ISO/TR 24971 & EU MDR Updates
Learn More
Guide
NAMSA Guide: In Vitro Diagnostic (IVDR) Readiness Guide
Learn More
White Paper
How to Select the Proper EU Notified Body for your Medical Device Organization
Learn More
Guide
NAMSA Guide: EU MDR & IVDR Regulation Tool
Learn More
White Paper
Leveraging Post-Market Surveillance & Post-Market Clinical Follow-Up Data to Support EU MDR Compliance
Learn More
Video and Podcast
European Market , IVD , Regulatory
February 22, 2023
European Parliament to Amend MDR/IVDR Transitional Provisions
By: Dr. Rachel Gibbs, PhD, BSc
European Market , Regulatory
December 16, 2022
MDR Update: EPSCO Proposes Transition Improvements and EU Commission Issues MDCG 2022-18
By: Kevin Butcher
Clinical & Consulting , European Market , Regulatory
December 6, 2022
EU Commission Publishes MDR Implementing Regulation for Devices without Medical Purpose (Annex XVI)
Jane Arnold-Round
By: Jane Arnold-Round
European Market , Regulatory
September 1, 2022
MDCG 2022-14: Transition to the MDR and IVDR – Notified Body Capacity and Availability of Medical Devices and IVDs
By: Kevin Butcher
European Market , IVD , Regulatory
August 15, 2022
MDCG 2022-10: Interfaces between the Clinical Trial Regulation and IVDR
By: Alex Laan
European Market , IVD , Regulatory
July 21, 2022
MDCG 2022-3: Verification of Manufactured Class D IVDs in accordance to the IVDR—One Size Fits All?
By: Alex Laan
European Market , IVD , Regulatory
June 30, 2022
The New UK MHRA Medical Device Regulations: Impact to IVD Manufacturers
Christèle East, PhD
By: Christèle East, PhD
European Market , Regulatory
June 28, 2022
New UK MHRA Medical Devices Regulations Published
By: Kevin Butcher
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 , Regulatory
May 9, 2022
New MDCG 2022-5 Guidance on Borderline between Devices and Drugs under MDR
Jane Arnold-Round
By: Jane Arnold-Round
European Market , Regulatory
March 1, 2022
New MDCG 2022-4 Guidance Released
Sr. Regulatory Consultant
By: Thomas Miramond
European Market , Regulatory
January 20, 2022
New Implementing Regulation Released to Provide Guidance on Electronic Instructions for Use (eIFU) under MDR
David Mandley
By: David Mandley, PhD
European Market , Regulatory
January 13, 2022
European Commission Releases Further Harmonised Standards under EU MDR
David Mandley
By: David Mandley, PhD
Clinical & Consulting , European Market , Regulatory
May 25, 2021
May 26, 2021: Marking a Regulatory Milestone for EU Medical Device Manufacturers
By: Adrian Keene
European Market , IVD , Regulatory
November 24, 2020
New Guidance: Classification of IVD under the IVDR
By: Alex Laan
Clinical & Consulting , European Market , IVD , Regulatory
September 9, 2020
UKCA: A Wait and Watch Approach?
By: Richard Bassett
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 , Regulatory
April 9, 2020
European Commission Mandate for EU Parliament Negotiations on MDR Delay: Clarification Regarding Article 120(3)
By: Matt Royle
European Market , Regulatory
April 3, 2020
EU Response to COVID-19 Pandemic: Proposal to Delay Date of MDR Application to May 2021 for Certain Provisions
By: Matt Royle
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 , Regulatory
November 27, 2019
MDR Update: Draft Corrigenda Published Outlining Positive Impact to Class I Manufacturers and Up-Classification Rules
By: Adrian Keene
European Market , IVD , Regulatory
November 18, 2019
Key Requirements of Post-Market Surveillance under IVDR
By: Warren R. Jameson, PhD
European Market , IVD , Regulatory
October 30, 2019
IVDR Technical Documentation: 5 Critical Parameters of Change You Must Understand
By: Warren R. Jameson, PhD
Clinical , European Market , Regulatory
October 2, 2019
MDCG Issues Guidance on Summary of Safety and Clinical Performance under the Medical Device Regulation (MDR)
By: Dr. Vincent Legay
European Market , Quality , Regulatory
July 10, 2019
EU IVDR: Understanding the New QMS Requirements
By: Warren R. Jameson, PhD
European Market , Regulatory
March 20, 2019
Draft Corrigenda for EU MDR and IVDR Released
By: Adrian Keene
European Market , Regulatory
March 6, 2019
EMA Issues Q&A Regarding Impact of MDR, Article 117
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
January 10, 2019
Renewal Timelines Quickly Approaching for Medical Device Directive (MDD:M5) CE Mark Certificates
By: Stephan Buttron
European Market , Regulatory
October 17, 2018
EU Commission & MDCG Release New MDR & IVDR Guidance Documents
By: Adrian Keene
European Market , Regulatory
April 24, 2018
CE Marking of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR
By: Stephan Buttron
European Market , Regulatory
September 19, 2017
UK MHRA Publishes Guide to the New EU Medical Device and IVD Regulations
By: Stephan Buttron
European Market , Regulatory
July 26, 2017
EU MDR Poses Significant Changes for Importers and Distributors
By: Stephan Buttron
European Market , Regulatory
April 20, 2017
MDR Transition Timelines for Legacy Medical Devices – Not without Risks and Undue Burden
By: Anney Peterson
European Market , Regulatory
June 1, 2023
Reflecting on the Second Anniversary of the EU Medical Device Regulation
David Mandley
By: David Mandley, PhD
European Market , Regulatory
April 28, 2023
Just Released: Updated Transitional Arrangements for UKCA Process
By: Kevin Butcher
European Market , Regulatory
June 22, 2023
UK Extends Transition Period for Medical Device and IVD Products in New Legislation
Jane Arnold-Round
By: Jane Arnold-Round
European Market , Regulatory
March 8, 2023
UK MHRA Advisory Group Publishes Proposals
By: Kevin Butcher
IVD , Regulatory
November 21, 2023
Why IVD Developers Must Embrace the IVDR Transition Now
By: Warren R. Jameson, PhD
European Market , Regulatory
December 4, 2023
MDCG 2022-11 Rev 1: Urgency for MDR and IVDR Compliance
By: Kevin Butcher
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 , Regulatory
July 26, 2018
EU Commission Issues Supplementary Guidance Information for CE Marks Under MDR & IVDR
By: Dr. Vincent Legay
Approved IVDR Notified Bodies
  • 3EC International a.s. (Slovakia)
  • BSI Group The Netherlands B.V. (The Netherlands)
  • DEKRA Certification B.V. (The Netherlands)
  • DEKRA Certification GmbH (Germany)
  • Eurofins Electric & Electronics Finland Oy (Finland)
  • GMED SAS (France)
  • QMD Services GmbH (Austria)
  • MDC MEDICAL DEVICE CERTIFICATION GMBH (Germany)
  • National Standards Authority of Ireland (NSAI) (Ireland)
  • Sertio Oy (Finland)
  • TÜV Rheinland LGA Products GmbH (Germany)
  • TÜV SÜD Product Service GmbH (Germany)

Access this list by clicking here.

White Paper
Expanding your Market: Submitting U.S. EUA COVID-19 Products for EU IVDR Compliance
Learn More
White Paper
The EU In Vitro Diagnostic Regulation (IVDR): Clarification Regarding Commonly Asked Questions
Learn More
Guide
IVDD to IVDR: How to Successfully Make the Transition
Learn More
White Paper
EUDAMED Actor Registration Module: A Step Towards Greater Medical Device and IVD Product Safety and Transparency
Learn More
White Paper
Risk Management Systems: Implications of ISO 14971, ISO/TR 24971 & EU MDR Updates
Learn More
Guide
NAMSA Guide: In Vitro Diagnostic (IVDR) Readiness Guide
Learn More
White Paper
How to Select the Proper EU Notified Body for your Medical Device Organization
Learn More
Guide
NAMSA Guide: EU MDR & IVDR Regulation Tool
Learn More
White Paper
Leveraging Post-Market Surveillance & Post-Market Clinical Follow-Up Data to Support EU MDR Compliance
Learn More
Guidance Documents

NAMSA has compiled the following links as a reference for additional information on MDR and IVDR:

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

Please contact us or visit our regulatory consulting webpage here to learn about our services.

 

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