MDR and IVDR: How prepared is your business for the new regulations?
MDR and IVDR transition periods for legacy products – what manufacturers need to know
On March 20, 2023, Regulation (EU) 2023/607 was published in the Official Journal of the European Union. This new regulation is a targeted amendment of the EU MDR (Regulation EU 2017/745) and the EU IVDR (Regulation EU 2017/746) which formally extends the MDR transition period, along with other changes, for legacy devices covered by a valid MDD/AIMDD certificate. The new regulation is entered into force immediately.
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 new 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.
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.
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.
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.
MDR/IVDR brings higher costs and bottlenecks
Is your business strategy in place for a successful transition?
The new EU medical device regulations (MDR) and in vitro diagnostic device regulations (IVDR) will begin going into effect in just a few months, at the start of 2020. As a result, some under-prepared manufacturers will be forced to pull some or all of their products off the EU market, while others will face significant delays.
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.
EU Regulations and MDR/IVDR blogs
MDR 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
As of 15 December 2021, the European Parliament and the European Council have adopted their proposal to make the suggested progressive IVDR rollout timeline official.
EC proposes extended transition period for IVDR compliance
As of October 14, 2021, the European Commission (EC) has issued a proposal for a modified rollout of the new In Vitro Diagnostic Regulation (IVDR).
MDR & IVDR bottlenecks: Challenges persist despite deadlines
The new In Vitro Diagnostics Regulation (IVDR) and Medical Device Regulation (MDR) provide regulatory frameworks and conformity assessments that promote medical device safety and efficacy.
Legacy devices under MDR/IVDR: a path forward
Regulations from 2017 set stricter requirements on manufacturers product development, data reporting, and quality assurance in place.
Developing a strategy for high risk devices under IVDR
The In Vitro Diagnostic Regulation (IVDR 2017/746), provides a harmonised regulatory framework to ensure the safety and performance of devices in the European Union (EU).
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.
Risk, vigilance, and remediation under IVDR
To comply with the IVDR, manufacturers must ensure proper technical documentation, conformity assessments, quality management requirements and post-market surveillance (PMS).
MDR / IVDR Regulatory Roundup
Moreover, until recently, no NBs had been designated under the new In Vitro Diagnostic Regulation (IVDR), creating a barricade to any in vitro diagnostics (IVDs) entering the EU market under the new rules.
The need for new business models under MDR/IVDR
The direct costs of complying with these new directives are high, and manufacturers will need to allocate a substantial budget annually for the first three years.
Managing COVID disruptions within IVDR timelines
The COVID-19 pandemic has greatly impacted the IVD industry, including travel and social distancing restrictions, creating hassles and stalling NB designation processes.
EMA publishes second draft guideline on new MDR rules
The European Medicines Agency (EMA) recognised that DDCs will become more commonplace as technology continues to advance.
How to manage the impact of COVID-19 on IVDR timelines
The IVDR brings significant changes to the IVD industry with CE certification by a notified body (NB) now becoming the rule rather than the exception.
Overcoming IVDR challenges for companion diagnostics
The rise of personalised medicines has led to an increased demand for companion diagnostics (CDx). These in vitro diagnostics (IVDs) increase the probability of clinical success.
Navigating the EU’s IVDR compliance deadlines amid uncertainty
With the rapidly approaching deadlines to comply with the new European Regulation (IVDR), IVD manufacturers will need to prepare for an ever-evolving clinical and regulatory landscape.
What will pandemic disruptions mean for EU IVDR?
Certification under the old EU In Vitro Diagnostic Directive (IVDD) cannot be grandfathered into IVDR. IVD manufacturers must start prioritising product portfolios and conducting gap assessments .
Keeping up with regulatory changes: EU MDR and IVDR
An explanation to how the disruption of the present pandemic is being realised by the medical device industry, with IVD manufacturers being no exception to this.
A strategic business plan to ensure success under MDR/IVDR
Manufacturers should immediately begin developing a strategic business model that will prepare them for success under the new MDR and IVDR reforms.
Assessing the impact of MDR and IVDR on patients
The challenges that medical device manufacturers will face as these new regulations are introduced, and how these challenges will ultimately affect the patients.
EU Regulations on-demand webinar recordings
Medical device experience and expertise at ICON
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