It’s time to take action now.
Here’s why it’s important.
The new Europe In Vitro Diagnostic Medical Device Regulation (IVDR) is on the horizon. While the 2022 deadline may seem distant, manufacturers need to start taking steps now to achieve compliance. The increased number of modifications, definitions, classifications, and conformity assessments will involve careful evaluation and process revisions. Significant requirements for clinical evidence will also be enforced, with an increased focus on intended use and user environment. Most notably, individual trials for each unique product will be required, with a user environment relative to laboratory, near-patient testing (NPT) and self-testing.
Key dates to remember:
- 26th March 2020 – Eudamed will go live.
- 26th May 2022 – IVDR date of application.
- 26th May 2024 – AIMD, MDD and IVDD certificates become void; after this date devices will no longer be approved for the EU market under these certificates.
- 26th May 2025 – Devices can no longer be put into service in the EU using AIMD, MDD or IVDD certificates.
How Oxford can help.
If you have limited internal resources or need help developing your strategy, Oxford can provide you with experienced consultants and planning support. Our flexible recruiting and consulting services are tailored to fit your needs and can support a range of projects including:
- Conducting a review of manufacturer requirements
- Performing a gap assessment against your existing Quality Management System (QMS)
- Amending and implementing your QMS
- Applying an amended QMS to your product portfolio
Learn how a large pharmaceutical organisation was able to achieve compliance and deliver 50 new combination products to market.
Plan Your Path to Compliance
Prepare your organisation before you take official steps.
Have an expert review your current Quality Management System (QMS) to identify anything missing that would prevent your compliance with IVDR.
Engage consultants to amend and implement changes to your QMS and provide all necessary documentation.
Implement a training program to inform all team members about IVDR-related changes that have been made to your production process.
Get an IVDR expert to conduct a mock inspection to see if they can find any instances of IVDR noncompliance in your facility.
Conduct tests to verify that your IVDR-compliant process works flawlessly in every situation.
6 Official Steps to IVDR Compliance
(this does not apply to most Class A IVD medical devices)
First things first.
Get started now to stay on track.
Our detailed infographic outlines the steps you need to take to achieve IVDR compliance.
Tap into our network of talent.
With our global network of consultants, we can help you find the right individual talent, or help you build your own custom project team. Many of our IVDR compliance experts have held senior positions with leading IVD manufacturers; their experience and knowledge enables us to offer best-in-class IVDR expertise.