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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In Vitro Diagnostic Regulation
In Vitro Diagnostic Regulation
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IVDR In Vitro Diagnostic Regulation

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.

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.

Why is this change so significant for IVD manufacturers?

The current legislation, in the form of the IVD Directive, was written for a young industry, without broad scope or scalability. As the industry has evolved, the Directive has become outdated. The new Regulation addresses some of the challenges posed by the Directive, including a new rule-based classification system for products, superseding the current list-based approach. This in itself makes the Regulation more practical, by allowing it to remain relevant to an innovative and growing industry. It also means that a far larger number of IVD manufacturers require a notified body to certify their products, as classification rules are applied to all IVDs, rather than using an exclusive list of specific products to determine which require a notified body. Under the IVD Directive, 90% of the industry could self-certify, but with the Regulation, up to 90% of the industry now requires a notified body.

In addition to the change in classification rules, we also see increased harmony between the IVD Regulation and the equivalent Medical Device Regulation, including a focus on clinical evaluation, and increased control over the wider supply chain.