MDR and IVDR: How is your business progressing toward implementation of the regulations?
MDR and IVDR transition periods for legacy products – what manufacturers need to know
The European Union’s Medical Device Regulation (MDR) came into effect on 26 May 2021 followed by the In Vitro Diagnostic Device Regulation (IVDR) the following year (26 May 2022). These regulations brought with them elevated clinical requirements, re-classified and up-classified devices, and a changing role for notified bodies. A perfect storm of complicating factors – including the COVID pandemic, global supply chain disruptions, the limited capacities of notified bodies certified to the new regulations, and the fact that economic operators themselves have been slow to prepare for the transition - have threatened the supply of medical devices and diagnostics to the European market.
In response to these concerns, the European Commission has extended the transition periods for these regulations. For manufacturers with legacy medical devices and diagnostics that have current certificates, but have not yet completed the MDR or IVDR certification process, extension of the transition period provides welcome relief, but conditions apply. ICON’s dedicated medical device experts have proven experience with supporting companies in successful transitions to the EU MDR and EU IVDR, and are intimately knowledgeable about the targeted amendment. To learn more, please contact us.
Demystifying EU CTR, MDR and IVDR
Download now and demystify the EU regulation process for medical devices, in vitro diagnostic devices and combined studies.
EU MDR and IVDR transition extension: What changes do you need to know about?
Read this briefing document to understand the MDR amendment, including transition period extension and conditions and the current status of IVDR.
Developing and commercialising medical devices and In-Vitro Diagnostics
The key to success under MDR and IVDR
Read the "Getting Ready for Europe’s New Rules: A Guide for Successfully Developing and Commercialising Medical Devices and In-Vitro Diagnostics under MDR and IVDR" white paper to learn how to effectively prepare for these imminent regulatory changes.
IVDR technical file remediation
Understanding technical file requirements for a successful transition
The new In Vitro Diagnostics Regulation (IVDR) requirements impact the entire IVD lifecycle. As a result, manufacturers may be experiencing significant increases in workloads across the medical device and diagnostic value chain. Discover the key elements of a successful IVDR techical file remediation strategy in this factshet.
The IVDR journey
A roadmap to meet 2022 deadlines, while navigating pandemic disruptions
The IVDR, alongside the Medical Device Regulation (MDR), provides a harmonised regulatory framework to ensure the safety and performance of devices. Major impacts of the IVDR include greater transparency, extended scope, increased oversight, heightened traceability, stricter requirements, as well as analytical performance and scientific validity.
In this whitepaper, we lay the groundwork for a successful transition.
Latest on Regulatory Intelligence
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Blogs
Submission strategies for combined studies in the EU
In this article we look at how an oncology study sponsor managed their submission process which spanned more than 30 countries, many in the EU.
Integrating Performance Studies of In-Vitro Diagnostics into Clinical Trials: A Complex Challenge
We explore how to navigate the nuances of regulations and embrace collaborative initiatives to overcome challenges and unlock the full potential of combined trials.
MDR transition period and certification bottleneck
It is of paramount importance that companies with expiring certification begin the process to remain compliant under the new MDR. Read more about identified challenges and solutions.
Progressive IVDR rollout made official
In the fall of 2020, the European Commission issued a proposal to modify the implementation timeline for the new In Vitro Diagnostic Medical Devices Regulation (IVDR). Now, as of 15 December 2021, the European Parliament and the European Council have adopted this proposal, making the suggested progressive IVDR rollout timeline official.
EC proposes extended transition period for IVDR compliance
The European Commission has issued a proposal for a modified rollout of the new In Vitro Diagnostic Regulation (IVDR).
Clinical Evidence under IVDR - how much is enough?
The new In Vitro Diagnostic Regulation (IVDR) aims to harmonise regulatory framework across the European Union (EU) to ensure the safety and performance of devices by placing greater responsibility on manufacturers to demonstrate that their products meet stringent requirements.
A New Reality: EMA Published First Guidance on New MDR/IVDR Rules for Certain Devices
EMA recently published the first of a series of guidance documents to help applicants prepare for obligations enforced by new EU regulations on medical devices.
How Manufacturers Can Prepare for the Challenges IVDR Presents
Adjusting to the IVDR: Creating Clinical Evidence for In Vitro Diagnostics
MDR / IVDR Regulatory Roundup
Less than one year remains before the European Union’s new Medical Device Regulation (MDR) goes into effect on May 26, 2020, and only about a fourth of medical device companies plan to be fully complaint,
The Need for New Business Models under MDR/IVDR
The new MDR/IVDR will go into effect in 2020, greatly increasing the complexity of keeping existing products on the market and introducing new ones.
Media contributions
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Media article: Overcoming IVDR challenges for companion diagnostics
Angela Brown and Nicole Cowan provide expert commentary on overcoming IVDR challenges for companion diagnostics.
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Media article: A Strategic Business Plan to ensure success under MDR/IVDR
David Novotny and Angela Brown share their insights in this Medical Design and Outsourcing article as to how manufacturers can develop a strategic business model that will prepare them for success under the new MDR/IVDR reforms
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Media article: Assessing The Impact Of MDR & IVDR On Patients
In Diagnostics World's recent article featuring commentary from ICON experts David Novotny, Angela Brown and Nicole Cowan, they discussed the need to assess the impact of MDR/IVDR on patients after the new medical device regulation is established.
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Media article: Regulatory bottlenecks mean EU clinicians & patients could lose access to medical devices under new rules
A recent press release by Samedan LTD Pharmaceutical Publishers on ICON’s scheduled presentation to be given at The Medtech Conference 2019, ‘MDR/IVDR – What now?’, during which our experts will discuss the findings of the whitepaper ‘Higher Costs & Bottlenecks’, looking at the future implications of the new MDR/IVDR rules on the EU market.
EU Regulations on-demand webinar recordings
Medical device experience and expertise at ICON
ICON's dedicated team can assist with all phases of your clinical trial development and testing to successfully bring your product to market.