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IVDR Notified Body Numbers – Has Enough Progress Been Made?

News posted on 18 January 2019 on Medtech Insight
Author: Amanda Maxwell  |  Source of Original Article

Executive Summary

Will there be enough resources for IVD manufacturers to be audited in time against the EU’s IVD Regulation? A survey from TEAM-NB reveals a drop in notified body numbers just at a time when more resources are needed.

There are only 11 notified bodies in the process of becoming designated against the new IVD Regulation, compared to the 22 currently designated against the IVD Directive (IVDD).

That’s according to responses from a “Survey On NBs’ Applications Against The New IVD Regulation,” carried out by EU notified body association, TEAM-NB. The figures are an update to those released by the European Commission in December 2018. (Also see “Good Progress Toward Notified Body Designations: But Is There A Threat? ” – Medtech Insight, 13 Dec, 2018.)

Most of the notified bodies that are more advanced in the designation process are members of TEAM-NB. The press release also demonstrates that TEAM-NB members tend to be responsible for significantly more IVD certificates than non-members. This is probably good news for industry in terms of speed of availability of notified body resources under the IVDR – not least because of the time it takes to designate a notified body and the significant demand that is anticipated once these notified bodies are designated.

Pressure Is On

As a reminder, just some 10%-15% of IVDs need to be assessed by a notified body under the current IVDD, but some 85%-90% of IVDs are expected to fall into the risk classes requiring notified body involvement under the IVDR, massively increasing the demand for services.

Under IVDR, there is a “derogation” to extend the deadlines for application for many products that comply with the regulation as of its full date of application on May 26, 2022. But this derogation does not apply to any products that are being upclassified and need a notified body for the first time, which is the clear majority of products.

This means that even if 19 applicant notified bodies are designated against the new IVDR, there will still be a huge demand for limited resources. Even though the May 26, 2022, effective date may seem to provide plenty of time for compliance, manufacturers that delay will be dealing with increased competition for notified body attention.

The same notified body departments that are dealing with IVDs are likely to be still dealing with auditing companies against the Medical Devices Regulation (MDR), which fully applies two years earlier than the IVDR. It’s not as if notified bodies will have finished assessing MDR manufacturers by May 26, 2020. Many manufacturers will be able to make use of the MDR extension period, but it is during that extension period, and just when IVD manufacturers will be seeking notified body slots, that they will also be aiming to be audited by the notified bodies against the MDR.

Bottlenecks are reportedly already occurring. Some notified bodies are reporting to be handling the pressure by being particularly harsh in assessing manufacturers’ compliance, as a forthcoming article in Medtech Insight will reveal.

IVD Areas Where TEAM-NB Members Want To Work

When it comes to specific areas of interest for Team-NB members:

  • 81% or more intended/intend to apply for all codes of devices meant to be used as “controls without a quantitative or qualitative assigned value” and “in sterile condition;”

  • 69% or more intended/intend to apply for all codes of devices meant to be used “for markers of cancer and non-malignant tumors” and “for human genetic testing;”

  • 63% intended/intend to apply for all codes of devices meant “to determine markers of infections / immune status” and “for non-infectious pathologies, physiological markers, disorders / impairments (except human genetic testing), and therapeutic measures;” and

  • 56% intended/intend to apply for all codes of devices meant “for blood grouping” and “for tissue typing.”

TEAM-NB Members Hold Lion’s Share Of IVD Market?

TEAM-NB demonstrates in the survey report that the number of IVDD certificates issued by TEAM-NB members that are currently valid seems to far outstrip those issued by notified bodies that are not members of TEAM-NB, at least among the 11 TEAM-NB members and seven non-members that responded to teh relevant survey question.

While seven non-members and 5 TEAM-NB members replied that they have issued up to 50 still valid IVDD certificates, among the TEAM-NB members: 1 member had issued between 50 and 100 certificates; 3 members had issued between 100 and 200 certificates; and 2 members had issued between 200 and 500 certificates.

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