Here’s Why it’s Important to Take Action Now
We are in midst the transition from the IVD Directive 98/79/EC to the new IVD Regulation (EU) 2017/746. As the May 26, 2022 deadline has come and gone, it is now more critical than ever to take action. Manufacturers will have started taking the appropriate steps to achieve compliance with the IVDR, but due to the high complexity of the regulation, many resources will still be needed.
Risk-based re-classifications, increased involvement of Notified Bodies and conformity assessments involve careful evaluation and process revisions. Requirements for clinical evidence and performance evaluation will 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:
May 26th 2022 for non-sterile self-declared Device
May 26th 2022 for all new Devices
May 26th 2025 for High-risk Class D Devices
May 26th 2026 for Moderate-risk Class C Devices
May 26th 2027 for Class B Sterile Diagnostic Devices
May 26th 2027 for Class A Sterile Diagnostic Devices
How Oxford Can Help
Oxford can provide you with experienced consultants and planning support, as well as with Medical Writing resources. Our flexible staffing 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
- Medical writing of different types of documents required by the IVDR, such as Performance Evaluation Plans, Performance Evaluation Reports, Scientific Validity Reports and other medical writing services.
Learn how a large pharmaceutical organization was able to achieve compliance and deliver 50 new combination products to market.
Plan Your Path to Compliance
Prepare your organization before you take official steps.
Gap
Assessment
Remediation
Training
Mock
Inspection
Testing
Gap Assessment
Have an expert review your current Quality Management System (QMS) to identify anything missing that would prevent your compliance with IVDR.
Remediation
Engage consultants to amend and implement changes to your QMS and provide all necessary documentation.
Training
Implement a training program to inform all team members about IVDR-related changes that have been made to your production process.
Mock Inspection
Get an IVDR expert to conduct a mock inspection to see if they can find any instances of IVDR noncompliance in your facility.
Testing
Conduct tests to verify that your IVDR-compliant process works flawlessly in every situation.
IVDR Steps
✓ Determine product classification
✓ Appoint person responsible for regulatory compliance (PRRC) in organization
✓ Revising QMS for IVDR compliance
✓ Obtaining Notified Body accreditation of revised QMS
✓ Prepare technical documentation file
✓ Obtain and have technical documentation audited and accredited by Notified Body
✓ Within supply chain, identify Economic Operators (EO)
✓ Obtain unique device identifier (UDI)
✓ Submit key manufacturer and authorized representative information to EUDAMED
✓ Obtain certification from Notified Body (approval to affix CE mark to product)
✓ Place CE mark to product labeling
✓ Place your CE marked product into the European market
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.