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.
Read this briefing document to understand the MDR amendment, including transition period extension and conditions and the current status of IVDR.Read more
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.Read the whitepaper
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.Read the whitepaper
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.Read the whitepaper
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.Read the factsheet
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.
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.
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).
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.
Regulations from 2017 set stricter requirements on manufacturers product development, data reporting, and quality assurance in place.
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).
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.
To comply with the IVDR, manufacturers must ensure proper technical documentation, conformity assessments, quality management requirements and post-market surveillance (PMS).
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 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.
The COVID-19 pandemic has greatly impacted the IVD industry, including travel and social distancing restrictions, creating hassles and stalling NB designation processes.
The European Medicines Agency (EMA) recognised that DDCs will become more commonplace as technology continues to advance.
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.
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.
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.
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 .
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.
Manufacturers should immediately begin developing a strategic business model that will prepare them for success under the new MDR and IVDR reforms.
The challenges that medical device manufacturers will face as these new regulations are introduced, and how these challenges will ultimately affect the patients.
European clinicians and their patients could lose access to vital medical devices, including in-vitro diagnostics, due to a lack of agencies able to certify products in time to comply with strict new regulations.
ICON's dedicated team can assist with all phases of your clinical trial development and testing to successfully bring your product to market.
Read more about ICON's services in medical devices and diagnostics