In Vitro Diagnostic Medical Devices

In Vitro Diagnostic Medical Devices

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In Vitro Diagnostic Medical Devices
In Vitro Diagnostic Medical Devices
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Unrivaled expertise from an EU Notified Body and UK Approved Body

As a manufacturer of an in vitro diagnostic (IVD) medical device, you must ensure you meet the relevant regulatory requirements before placing your product onto the market; for the EU, these are  outlined in the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 and, for the UK, the UK Medical Devices Regulations (UK MDR) 2002.

As an EU Notified Body and UK Approved Body our technical specialists have years of experience and can support you through the process of bringing your medical device on to the market.

IVD brochure

Learn more about how our IVD technical specialists can review and confirm your product’s readiness for market.

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IVDR revised transition provisions

REGULATION (EU) 2022/112 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices.

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The Covid-19 pandemic and the value of IVDs

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 EU IVDR and UKCA certification under the UK MDR (2002). 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

Resources to support you

BSI issues its first certificate to the In Vitro Diagnostic Devices Regulation

Read the story >

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 EU IVDR?

BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme. 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. Our expanding specialist IVD team currently has 19 technical experts, two of which provide clinical oversight, with an average of over 20 years’ experience.

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Journal MDR logo

A notified body’s perspective on the clinical evaluation requirements under the Medical Device Regulation

Understanding of the clinical evaluation process for medical devices against the requirements of the MDR, relevant Medical Device Coordination Group guidance documents is critical for all manufacturers.

Hear from BSI’s Richard Holborow, Head of Clinical Compliance in his recent article in the Journal of Medical Device Regulation on the requirements for clinical evaluation under the MDR from a Notified Body’s perspective and how to meet those requirements.

Download the article

From the experts

For EU IVDR applications, have your IVD device portfolio well-organized (preferably around 'what is a device' according to how you are going to assign Basic-UDI-DI and UDI-DI) and understand your transition strategy. Requirements for Technical Documentation are defined in Annex II and Annex III of the IVDR – use this and our helpful IVDR Best Practices Guidelines to work on your Technical Documentation against the new requirements.

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