EU IVDR Consulting

Our consulting services will make
sure your company is fully prepared
for the new regulatory requirements.

The IVDR compliance requirements take effect on May 26, 2022, is your company prepared?

The In Vitro Diagnostics Regulation (IVDR) requires most IVD medical device manufacturers to obtain a CE Mark through a EU Notified Body. Our consulting services will make sure your company is fully prepared for the new regulatory requirements.

EU IVDR Consulting

In Vitro Diagnostics (IVDs) are undergoing a huge change to certification in Europe. Currently, most IVDs are self-certified, and do not require the involvement of a Notified Body. IVDR is expected to completely change this with nearly 85% of all IVDs requiring Notified Body involvement, leaving only 15% of IVDs eligible for self-certification.

*https://www.rivm.nl/bibliotheek/rapporten/2018-0082.html

IVDR regulation enforcement will begin on May 26, 2022.

Fang Consulting is equipped with the knowledge to provide regulatory consulting services and navigate the new EU IVDR regulation requirements to gain market approval. Our  consultants will educate your team on why and how the new regulations will likely impact your IVD products. We understand the impact of the new IVDR requirements, including technical documentation and post-market surveillance expectations. We also understand the needs of manufacturers with increased Notified Body involvement in obtaining CE Mark, which is new to many IVDs under the new IVDR.

OUR EU IVDR SERVICES

Impact Assessment

  • Device classification review
    • New rule-based risk classification compared to current IVDD list-based classification
  • New/updated required documentation
    • Performance evaluation plans and reports
    • Post-market surveillance plans and reports

Technical Documentation Gap Assessment

  • EU IVDR provides more specifics of what needs to be included in Technical Documentation

QMS System Gap Assessment

  • EU IVDR provides more specifics of what needs to be included in a manufacturer’s quality management system (QMS)

Notified Body Submissions/Reviews

  • All devices require Technical Documentation, UDI, and post-market surveillance
  • Notified Body conformity assessments required for most classes of devices

IVDR FAQS

Will IVDR be delayed like MDR was?

No. There are zero indications that the timeline will be extended.

When do I need certification to IVDR?

Unless you currently hold a valid IVDD CE certificate issued by a Notified Body that expires later, you must comply with IVDR by May 26, 2022.

Am I able to self-certify as I did under IVDD?

Most likely no.  About 85% of devices will now require a Notified Body to continue sales in the EU.

Who classifies my device?

The legal manufacturer classifies the device.  Your Notified Body will review the classification and rationale during the IVDR application process. Discrepancies between your determination and that of the Notified Body can add significant time to your certification, so correct classification with thorough rationale is essential.

How do I find a Notified Body who is currently designated for IVDR to certify for my device?
  1. Go to Current list of designations
  2. Use drop downs to filter for your product type
My current Notified Body is not on this list. Will they be?

Maybe.  There is no public database of applications and ETAs.  Contacting your current NB is the only way to get accurate information on your specific situation.

My product does not currently require Notified Body assessment under IVDD but with the introduction of the IVDR they will require NB certification. Is it possible to continue to put these on the market until May 2024 without being audited to the IVDR?

No, if IVDR requires Notified Body certification then your product must conform to IVDR by May 26, 2022 to place your product on the market after that date.

What is the IVDD transition period?

The transition period (May 26, 2022 – May 26, 2024) applies to products currently IVDD certified by a Notified Body with a valid certificate that are allowed to be placed on the EU market.  This does not apply to products that are self-certified under IVDD.

What about IVDD NB certified products not conforming with IVDR after the transition period (May 26, 2022 - May 26, 2024)?

All certificates to IVDD are void on May 27, 2024 and those devices can no longer be placed on the market.

My device has been on the market 20 years and has no complaints, but I do not have any clinical documentation, what can I do?

One option is to start collecting Post Market Clinical Follow-Up data now so you can leverage it for your submission. This can be difficult during COVID-19 restrictions, so consider PMCF surveys. They are a valid method and can be performed remotely without site visits or patient access.

If IVDR is not fully applicable until May 2022, why should I do anything now?

Very few companies have the data required to submit for IVDR because exponentially more information is required compared to IVDD.  Most companies also do not have a Notified Body under contract for IVDR.

Based on typical remediation timelines, start now to be certified in time to keep your products on the EU market.

I have ISO 13485:2016 already. That meets all my QMS requirements for IVDR, right?

No.  The current version of ISO 13485 does not cover all the required elements of IVDR so you will need to make some additions to meet those requirements.  All products (except Class A non-sterile) require a Notified Body audit of your quality system to IVDR elements.