In Vitro Diagnostics Medical Devices

What is an IVD medical device?

An IVD Medical Device is defined in the IVDR as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body…”

The definition then outlines the principle or sole purpose of these devices. Under the IVDR, an IVD medical device must have a medical application or purpose. For more clarity on the definition of IVD medical devices, please refer to the IVDR (EU) 2017/746.

Our IVD team has a broad range of industry and regulatory experience, including product design and development, manufacturing, testing and regulatory expertise, and is able to offer CE certification services for IVD medical devices under the IVDR. Examples of products we cover include:

  • Blood glucose monitors
  • Cancer diagnostics
  • Clinical chemistry assays
  • Companion diagnostics
  • Devices for blood grouping
  • Devices for the detection of infectious agents
  • Devices for human genetic testing
  • Devices for tissue typing
  • Immunoassays
  • PCR assays including next generation sequencing panels
  • Self-tests and near-patient testing devices

What is the IVDR?

The IVDR is the new EU legislation applicable to IVD medical devices being placed on the EU market. Entering into force on the 25 May 2017 marking the start of a five-year transition period for manufacturers and economic operators, the IVDR replaces the EU In Vitro Diagnostics Directive (IVDD) 98/79/EC. Manufacturers wishing to apply to a notified body for a conformity assessment of their IVD medical device have until the Date of Application of the IVDR in May 2022 to update their Technical Documentation to meet the requirements and comply with the new, more stringent Regulation.

The IVDR brings with it significant changes to the regulatory requirements for IVD medical device manufacturers and introduces a new rule-based classification system with stricter notified body oversight, as well as significant changes to the depth and requirements of the associated Technical Documentation. It also brings changes to the relationship between manufacturers and economic operators.

For devices that are currently self-declaring conformity under the IVDD, May 2022 is the final deadline for a manufacturer to have received successful CE certification by a Notified Body. This new rule-based classification system supersedes the current list-based approach in the IVDD.

Why choose BSI for your product compliance to the IVDR?

One of the most significant changes introduced by the IVDR is the level of oversight from the notified bodies and third parties. Many IVD medical devices currently on the market in Europe under the IVDD are self-certified and notified body involvement isn’t required. This changes significantly under the IVDR with the majority (up to 90%) of IVD medical devices subject to notified body conformity assessment before being brought onto the market.

BSI has two Notified Bodies, one in the UK (0086) and one in the Netherlands (2797), both of which have full scope designations to the IVDR and MDR. The expertise of our IVD team means we are able to review devices covering over 80 NBOG codes.

Our IVD specialists are product experts in their respective fields and have undergone rigorous regulatory training. We are justifiably proud of our status in the industry as a full scope IVDR Notified Body, which includes IVDs. Nowhere is this more apparent than in our level of experience; our expanding specialist IVD team currently has 19 technical experts, two of which provide clinical oversight, with an average of over 20 years’ experience.

Key resources to support you with IVD

Dedicated training courses

IVD Directive to IVD Regulation Transition
Requirements of the IVDR for CE Marking
Implementation of the IVDR for CE Marking
Technical Files and design dossiers for IVDs
Performance evaluation and clinical evidence for IVDs
Application of the IVD Directive

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