In Vitro Diagnostic Regulation (IVDR)

In Vitro Diagnostic Regulation (IVDR)

The Date of Application of the IVDR is May 2022 to update technical documentation to meet the new requirements.

The Date of Application of the IVDR is May 2022 to update technical documentation to meet the new requirements.
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IVDR In Vitro Diagnostic Regulation
IVDR In Vitro Diagnostic Regulation
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IVDR In Vitro Diagnostic Regulation

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.

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 the IVDR?

The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the new EU legislation applicable to in vitro diagnostic (IVD) medical devices. 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.

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

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Why is this change so significant for IVD medical device manufacturers?

The new Regulation brings with it significant changes to the regulatory requirements for IVD medical device manufacturers and introduces a new rule-based classification system with increased Notified Body involvement. The new rule-based system supersedes the current list-based approach in the Directive. This change means that, as classification rules will be applied to all IVD medical devices, up to 90% of IVD medical devices will require a notified body for conformity assessment.

In addition to the change in classification rules, there is also increased harmony between the IVDR and the Medical Device Regulation (MDR), the equivalent for medical devices, including a focus on clinical evaluation and increased transparency through the wider supply chain.

IVDR resources to support you

Why choose BSI for your CE marking approval?

BSI The Netherlands is a leading EU Notified Body; we review Technical Documentation as part of a conformity assessment to ensure that medical devices meet the necessary safety and performance requirements to allow them to be placed on the market.

The BSI team has a unique set of expertise from our product and regulatory experience that allows us to provide a rigorous review of your Technical Documentation. This gives confidence in your certification to you and your key stakeholders.

BSI offers Technical Documentation review; you will be assigned a dedicated Scheme Manager to work with you throughout your product certification journey and will remain your point of contact thereafter.

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