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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Placing your In Vitro Diagnostic Medical Device on the market

As an IVD manufacturer, you must ensure that your product meets the relevant regulatory requirements before being placed to the market.

It is critical to work with a trusted EU Notified Body or UK Approved Body that understands the industry and has the experience to review and confirm your product’s readiness for market.

  • Notified Body - BSI The Netherlands (2797) - reviews medical devices to ensure their conformity to the European Regulations.
  • Approved Body - BSI UK (0086) - provides conformity assessments under the UKCA Scheme.

We truly understand the challenges that medical devices manufacturers face bringing compliant products on to market efficiently and safely. Whether you're starting the certification process or looking to transfer to BSI, we offer a range of flexible product review services providing you with efficient pathways to bring your product to market.

IVDR

BSI statement on conformity assessment for class D devices under the IVD Regulation

BSI would like to draw your attention to an important update regarding notified body activity for Class D IVDs under the In Vitro Diagnostic Regulation (IVDR) EU 2017/746.

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IVD brochure

IVD brochure

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

Download IVD brochure

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 information on regulatory requirements consult:

For additional information on legislations regulating IVDs and transition timelines, visit our IVDR, CE marking and UKCA marking dedicated webpages.

Resources to support you

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

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What is the EU IVDR?

The EU IVDR is the new 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 EU 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 IVD medical device manufacturers 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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A notified body’s perspective on the clinical evaluation requirements under the Medical Device Regulation

jmdr articleUnderstanding 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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