The Risk Based Classification System Under IVDR 2017/746

One of the key changes in the new IVDR Regulation 2017/746, is the introduction of a risk-based classification system for IVD devices.  Under the new risk-based classification system, the majority of IVD devices will need to undergo a Notified Body Conformity assessment. In this article, we look at the risk-based system and what it means for IVD manufacturers, importers, and distributors.

This represents a big change from the current IVDD 98/79/EC which allows for most IVD devices to be self-declared – with the exception of a list of IVD devices in Annex II List A and B – which require Notified Body conformity assessment.

This new risk-based classification system and subsequent likely Notified Body assessment will have a significant impact on IVD device manufacturers, many of whom have never undergone Notified Body assessment before.

IVDR Device Classifications

IVDR 2017/746 outlines 4 different classes A, B, C, D.

The A class IVD’s represent the lowest risk and D classified devices represent the highest risk.  Classification of IVD devices will take into account the intended purpose of the device and its inherent risks.

The majority of IVD’s that require Notified Body Conformity assessment will fall under B and C; a smaller number will fall under Class D, and they will also require Conformity assessment. Class A sterile devices will also require Notified Body conformity assessment.

IVD’s that fall under Class A (non-sterile) will not require an under conformity assessment due to their low risk.

Annex VIII of the IVDR outlines the Classification rules for IVD devices (Rules 1 to 7).

‘Implementing Rules’

Annex VIII also outlines 10 ‘Implementing rules’ which need to be considered before classifying an IVD device.

These ‘implementing rules’ include:

  • the application of classification rules separately to devices used in combination with each other;
  • classification of IVD accessories separately to the device with which they are used,
  • and the differentiation between software that drives /influences the use of a device and software that is independent of any other device.

This new classification system under IVDR 2017/746, is a marked contrast to the previous system under IVDD 98/79/EEC, in which IVD devices were categorised into ‘general IVD’s, self-testing IVD’s and Annex II List A and List B IVD devices’ and where conformity assessment was only required for IVD devices listed in Annex II List A and List B.

Notified Body Conformity Assessment Procedures

Under IVDR, for those IVD devices that fall Class A sterile, Class B, C, and D the following Notified Body conformity assessment procedures apply –

  • Class A sterile IVDs require an assessment by the NB of the sterile aspects according to Annex IX quality system (or Annex XI production quality assurance).
  • Class B IVDs require quality systems (Annex IX). Notified Bodies, as part of an on-site audit, will sample at least one technical file per generic device group (unless these IVD devices are self-testing or near-patient testing, in which case the technical documentation of all devices are required to be assessed)
  • Class C devices require either a full quality management system combined with Notified Body review of the technical documentation of at least one device per generic device group (Annex IX) or an EC type-examination (Annex X) together with production quality assurance or EC verification (Annex XI).
  • Class D requires the same procedure as Class C, together with batch verification and also the involvement of a reference laboratory (Annex IX)

Alternatively, an EC type-examination (Annex X) together with production quality assurance or EC verification (Annex XI) is also possible.

With IVDR 2017/746 fast approaching and coming into force on May 26, 2022, IVD manufacturers have a lot of work to do to ensure that their IVD devices conform to the new regulation, particularly for devices that now are required to under Notified Body conformity assessment.

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About the Author
Orla Keane
Medical Devices Manager
An engineer by background, she has 15 years experience in medical devices. Prior to joining Acorn Regulatory, she spent over 12 years at the HPRA in various roles within the medical devices team. She was responsible for a team within post market surveillance and vigilance across various general and active implantable medical device product families. Orla also served as co-Chair of the Compliance and Enforcement working group in Brussels for many years. She has previous industry experience at an orthopaedic implant manufacturer. Orla currently assists Acorn Regulatory clients in a variety of areas including regulatory strategy, EU authorised representative support and preparation for MDR, particularly on the topic of post market surveillance.
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Bronwyn Kelly
Senior Regulatory Affairs Advisor - Medical Devices
Bronwyn Kelly is a Senior Regulatory Affairs Advisor in our growing medical devices team. She has a wealth of experience in both device and pharmaceutical regulatory affairs and she has worked with some of the world's biggest companies in both sectors, In her current role she works with device clients on issues such as EU Authorised Representative and PRRC (Person Responsible for Regulatory Compliance) related issues.
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