EU MDR & IVDR Regulation Planning Resources

EU MDR & IVDR Planning Resources

The European Union’s (EU) Medical Device Regulation (MDR) was extended on 15 March 2023 to 26 May 2026 for Class III custom-made implantable devices, 31 December 2027 for Legacy Class III and IIb implantable devices, and 31 December 2028 for Legacy Class IIb, IIa, and I. Similarly, the In Vitro Diagnostic Regulation (IVDR) was extended to 26 May 2025 for Class D devices, 26 May 2026 for Class C, and 26 May 2027 for Class A (sterile) & Class B devices. 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.

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Webinar

The Basics of IVDR Clinical Studies

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Blog Posts

Clinical & Consulting , European Market , Regulatory

March 13, 2024

MDCG 2024-2: Procedures for the Updates of the European Medical Device Nomenclature

By: Kevin Butcher

Clinical & Consulting , European Market , Regulatory

February 13, 2024

MDR Vigilance: New MDCG Guidance Published

By: David Mandley, PhD

Clinical & Consulting , European Market , IVD , Regulatory

January 29, 2024

Navigating the Transition: Understanding the EU’s Proposed Amendments to IVDR

By: Warren R. Jameson, PhD

Clinical & Consulting , European Market , Regulatory

EU MDR & IVDR Regulation Planning Resources

EU MDR & IVDR Planning Resources

IVDR

MDR

Webinars

Clinical Challenges under the EU MDR

MDR Clinical Evaluation Reports: Key Elements and Lessons Learned for Successful Compliance

IVDR Implementation: First Steps for Compliance for Products Already on the European Market

Ensuring your Post-Market Surveillance Process Meets the New ISO 14971:2019 Guidance and MDR/IVDR Requirements

EU MDR Part 2: How to Approach Clinical Evidence Requirements with Clinical Management & Biostatistics

EU MDR Part 1: Current Opportunities & Challenges with Clinical Data-A NAMSA Panel Discussion

Impacts of the Updated ISO 14971 & Harmonization of MDR/FDA Rules on Risk Management

MDR 10.4.1: What Should we Really be Doing to be Prepared?

How to Select the Right EU Notified Body for IVDR Compliance

IVD Clinical Trials: Essential Components for Product Launch in 2019 & Beyond

EU MDR: General Safety & Performance Requirements for the Biocompatibility of Medical Devices

EU MDR 2017/745: Optimizing CERs within the Medical Device Lifecycle

Leveraging Post-Market Surveillance & Clinical Follow-Up Data to Support EU MDR Compliance

A Practical Guide to Writing Summaries of Safety and Clinical Performance

Telling Your Medical Device’s Story to Regulatory Agencies

4 Pillars of IVDR: Integrating Post-Market Surveillance, Risk Management, QMS & Performance Evaluation

The Basics of IVDR Clinical Studies

Blog Posts

MDCG 2024-2: Procedures for the Updates of the European Medical Device Nomenclature

MDR Vigilance: New MDCG Guidance Published

Navigating the Transition: Understanding the EU’s Proposed Amendments to IVDR

MDCG 2021-6 Rev 1: Clarifications on Clinical Investigations

MDCG 2022-11 Rev 1: Urgency for MDR and IVDR Compliance

Five Reasons Not to Delay Your MDR Certification

Why IVD Developers Must Embrace the IVDR Transition Now

MDCG 2023-4: Medical Device Software (MDSW) – Hardware Combinations

UK Extends Transition Period for Medical Device and IVD Products in New Legislation

Reflecting on the Second Anniversary of the EU Medical Device Regulation

Just Released: Updated Transitional Arrangements for UKCA Process

UK MHRA Advisory Group Publishes Proposals

European Parliament to Amend MDR/IVDR Transitional Provisions

MDR Update: EPSCO Proposes Transition Improvements and EU Commission Issues MDCG 2022-18

EU Commission Publishes MDR Implementing Regulation for Devices without Medical Purpose (Annex XVI)

MDCG 2022-14: Transition to the MDR and IVDR – Notified Body Capacity and Availability of Medical Devices and IVDs

MDCG 2022-10: Interfaces between the Clinical Trial Regulation and IVDR

MDCG 2022-3: Verification of Manufactured Class D IVDs in accordance to the IVDR—One Size Fits All?

The New UK MHRA Medical Device Regulations: Impact to IVD Manufacturers

New UK MHRA Medical Devices Regulations Published

MDCG 2022-8: Clarification of IVDR Requirements for Legacy Devices

MDCG 2022-2: Recommended Strategies for Data Retrieval and Literature Reviews

MDCG 2022-6: Transitional Provision Considerations for IVDR Conformity

New MDCG 2022-5 Guidance on Borderline between Devices and Drugs under MDR

New MDCG 2022-4 Guidance Released

New Implementing Regulation Released to Provide Guidance on Electronic Instructions for Use (eIFU) under MDR

European Commission Releases Further Harmonised Standards under EU MDR

May 26, 2021: Marking a Regulatory Milestone for EU Medical Device Manufacturers

MDCG Publishes New Guidance on Use of Standards Under MDR/IVDR

UKCA: A Wait and Watch Approach?

The IVDR Compliance Roadmap: From Start to Finish

European Commission Mandate for EU Parliament Negotiations on MDR Delay: Clarification Regarding Article 120(3)

EU Response to COVID-19 Pandemic: Proposal to Delay Date of MDR Application to May 2021 for Certain Provisions

Mapping QMS to EU IVDR Requirements: 3 Key Takeaways to Effectively Strategize QMS Implementation

MDR Update: Draft Corrigenda Published Outlining Positive Impact to Class I Manufacturers and Up-Classification Rules

Key Requirements of Post-Market Surveillance under IVDR

IVDR Technical Documentation: 5 Critical Parameters of Change You Must Understand

MDCG Issues Guidance on Summary of Safety and Clinical Performance under the Medical Device Regulation (MDR)

EU IVDR: Understanding the New QMS Requirements

EMA Issues Q&A Regarding Impact of MDR, Article 117

Renewal Timelines Quickly Approaching for Medical Device Directive (MDD:M5) CE Mark Certificates

EU Commission Issues Supplementary Guidance Information for CE Marks Under MDR & IVDR

CE Marking of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR

EU MDR Poses Significant Changes for Importers and Distributors

MDR Transition Timelines for Legacy Medical Devices – Not without Risks and Undue Burden

White Papers

Navigating Dual Regulations: Strategies for IVD Market Approval in China and the EU

Expanding your Market: Submitting U.S. EUA COVID-19 Products for EU IVDR Compliance

The EU In Vitro Diagnostic Regulation (IVDR): Clarification Regarding Commonly Asked Questions

IVDD to IVDR: How to Successfully Make the Transition

EUDAMED Actor Registration Module: A Step Towards Greater Medical Device and IVD Product Safety and Transparency

Risk Management Systems: Implications of ISO 14971, ISO/TR 24971 & EU MDR Updates

NAMSA Guide: In Vitro Diagnostic (IVDR) Readiness Guide

How to Select the Proper EU Notified Body for your Medical Device Organization

NAMSA Guide: EU MDR & IVDR Regulation Tool

Leveraging Post-Market Surveillance & Post-Market Clinical Follow-Up Data to Support EU MDR Compliance

Video and Podcast