2024 IVDR Sprint
The Ultimate Collection of Resources to Set the Pace on your Road to IVDR Compliance
If you are an IVD manufacturer looking to have your products compliant with the EU IVDR, you are probably aware that the deadline for some of your devices is coming very soon, but fear not! With over 2 decades supporting IVD clients access the European market, Veranex knows exactly the challenges you are going through, and the strategies to ensure an efficient pathway to regulatory compliance. We are in this together and we will be “sprinting” throughout 2024, to make sure you are fit for IVDR!
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Articles
Amending Regulation for MDR / IVDR: Key Takeaways for the Diagnostics Industry
The EU Parliament adopted the regulation amending EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to protect patients by ensuring the availability of safe devices that are essential for healthcare systems. The amending regulation extends the transition periods for certain IVDs (legacy devices and in-house devices) subject to the fulfilment of certain conditions and introduces a gradual rollout of EUDAMED and a new obligation for manufacturers to give a prior notice in case of disruption of supply. Veranex looks forward to the formal adoption by the European Council and the publication in the official journal of the EU. In the meantime, here’s a quick overview of the changes put forward by the amending regulation:
2024 IVDR Sprint: 6 Reasons Why You Should Start a Performance Evaluation Early
In accordance with Article 5(3) of Regulation (EU) 2017/746 (IVDR), a performance evaluation must be drawn up for every IVD placed on the European market, regardless of the device’s risk class (Yes, even class A devices require a proper performance evaluation!). The performance evaluation is based on a continuous process and follows a defined and methodologically sound procedure, taking into consideration the established device-specific plan, i.e., the Performance Evaluation Plan (PEP). See why it’s always a good idea to start the performance evaluation process as early as possible.
New Proposal for Extended Transition Periods for IVDs: Can Manufacturers Slow Down Transition Efforts?
The EU Commission recently published (January 23, 2024) a new proposal for amending the regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to protect patients by ensuring availability of safe devices that are essential for healthcare systems. With this proposal, the EU Commission is proposing to extend transition periods for certain IVDs (legacy devices and in-house devices) subject to fulfillment of certain conditions, gradual roll out of EUDAMED, and introducing a new obligation for manufacturers to give a prior notice in case of disruption of supply.
Technical Documentation under the Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR)
A medical device can only be placed on the European market once the manufacturer declares conformity of the device with applicable European Union (EU) regulations. Manufacturers provide evidence for conformity with the applicable regulations using a set of documents that comprehensively describe the medical device, including, among many other aspects, the intended purpose, design, manufacturing, verification and its validation. This set of documentation is called Technical Documentation (TD). The expected content of a TD is set out in Annexes II and III of Medical Device Regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR).
More Content Coming Soon
Webinars
2024 IVDR Sprint
How to Adopt a Proactive Approach to Ensure Timely Compliance with the Applicable Deadlines
February 27th, 2024
The Clinical Challenge
Addressing Increased Evidence Requirements in the EU IVDR Era
March 26th, 2024
Mastering Time and Compliance
How to Deal with Regulatory Requirements when collecting Clinical Performance Data
April 30th, 2024
Health Technology Assessment for IVDS
How to Deal with Regulatory Requirements when collecting Clinical Performance Data
May 2024
Companion Diagnostics (CDx)
Coordinate Development Timelines and Regulatory Requirements Between Drugs and Diagnostics
June 2024
Near Patient Testing Devices (POCT)
Generating Adequate Clinical Data and Ensuring Regulatory Compliance in Decentralized Settings
September 2024
Laboratory Developed Tests (LDT)
Adapting legacy and new in-house devices to the new EU IVDR regulatory framework
October 2024
Free Check-Up
Are you working towards IVDR compliance but need guidance to overcome specific issues you’re facing? This is the opportunity to ask questions and get expert answers from our team, which has 20 years of experience to pull from.
Register Now for an Exclusive and Complimentary 1-Hour Video Conference Session
During this session, you can ask your IVDR questions or receive our teams’ feedback on parts of your technical documentation. Based on our experience, the following documents are more likely to present significant deficiencies: Device Description, IFU, History of Change, GSPR Checklist, Risk Management File, PEP/PER, Usability Engineering File, PMS/PMPF plan. Please let us know what you would like to discuss as you book your slot.
By knowing your gaps in advance, you will be able to address them before submitting the technical documentation to your notified body, thus facilitating the conformity assessment procedure under IVDR. Register Now!
No dates available? Get in touch with Veranex’s IVD team!
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