Wake up to the IVDR! Today, the 26th of May is the “Date of Application” the date the new IVDR goes live. Many describe this as a cultural shift as it does not just change the regulation but in many cases the way we do business. It will impact all IVDs on the EU market and the associated supply chain.
What elements should be in place?
As from today all devices must meet the IVDR! There has been an extension to the transitional arrangements for some devices but do not lose site that the IVDR is now effective. Class A non-sterile devices do not have the benefit of an extension as these devices are self-declared and must meet the EU-IVDR, this includes extraction kits, accessories, and instruments. All new devices or existing devices that undergo a significant change will also have to meet the IVDR in full from 26 May 2022.
This document is essential reading MDCG 2022-8 Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC.
From 26 May 2022 ALL devices must:
- Update the QMS to meet the IVDR.
Update design control to include GRPRs for new devices and significant changes.
- Include an assessment of significant change according to MDCG 2022-06 in change control process.
- Implement IVDR post market requirements including PMS Plan, PMS Report, PMPF and vigilance. SSP and PSUR is not required prior to apply the IVDR but trend reporting is expected.
- Conduct clinical performance studies according to Annex XII and XIV as appropriate and address ISO20916.
- Identify a Person Responsible for Regulatory Compliance (PRRC) and formally appoint before placing the first product on the market under the IVDR.
- Registration of Economic Operators is required in EUDAMED, but it is not fully functional but will be required once it is operational per Article 112, 113(3)f of the IVDR. In the interim update supplier control and contracts as appropriate to ensure economic operators will be able to meet requirements when applicable.
Class A non-sterile devices in addition to the above
- Should have a full technical file
- Sign a declaration of conformity to the IVDR
Class A Sterile, B, C and D devices
- Read MDCG 2022-8.
- Additional relabeling of legacy devices is not required but compliance to the IVDD must be maintained in the transition. There is no requirement to add UDI see 2019-5 on registration of legacy devices in EUDAMED.
- Get ready for the IVDR and allow plenty of time for conformity assessments. Companies should ensure that they are in contact with a Notified Body to arrange conformity assessment and pay attention to their guidance documents regarding how they require a file to be presented.
Ensure you factor in sufficient time for the conformity assessment. Notified body approval can take 6-9 months or at lease 18 months for a CDx.
BEWARE - The extension to the transitional arrangements allows more time for conformity assessment activities, it does not delay the application of the IVDR.
How can Qserve help you?
Implementation of any new regulation is always a rollercoaster ride, and we know exciting times are ahead! We also understand that you are a global business and that the IVDR may have implications for other submissions, presenting both opportunity and threats.
Qserve supports customers at all points on their journey with different services.
Read more about the IVDR services Qserve supports.