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EU MDR & IVDR Planning ResourceS

EU Compliance Countdown

MDR

10
Months
17
Days
1
Hours

IVDR

22
Months
17
Days

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

The European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), originally published on 05 May 2017 by the EU Parliament, sets forth new and important requirements for medical device and in vitro diagnostic 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: the Active Implantable Medical Devices Directive (AIMDD), Medical Device Directive (MDD) and In Vitro Diagnostic Directive (IVDD).

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 now to ensure conformity by May 2020 (MDR) and May 2022 (IVDR), respectively.

NAMSA, in an effort to assist global medical device and 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 implementation of the new regulations.

Webinars
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
Learn More
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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Regulatory Pulse Blog
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 Jameson
European Market , IVD , Regulatory
October 30, 2019
IVDR Technical Documentation: 5 Critical Parameters of Change You Must Understand
By: Warren Jameson
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 Jameson
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
Uncategorized
April 20, 2017
MDR Transition Timelines for Legacy Medical Devices – Not without Risks and Undue Burden
By: Anney N. Majewski
White Papers
Guide
NAMSA Guide: In Vitro Diagnostic (IVDR) Readiness Guide
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White Paper
How to Select the Proper EU Notified Body for your Medical Device Organization
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Guide
NAMSA Guide: EU MDR & IVDR Regulation Tool
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White Paper
Leveraging Post-Market Surveillance & Post-Market Clinical Follow-Up Data to Support EU MDR Compliance
Learn More

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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