New In Vitro Diagnostic Regulation now published
The IVD industry is about to undergo significant change. The final text of the new European In Vitro Diagnostic Regulation (IVDR) has been published in the Official Journal of the European Union. The Regulation entered into force on May 25th, marking the start of the transition period for manufacturers selling IVD devices into Europe.
The IVDR, which replaces IVD Directive (98/79/EC), has a transition period of five years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.
See the latest information from the EU Commission here
The start of this long process of change occurred on 26 September 2012, when the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on medical devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices, which replaces the existing three Medical Device Directives.
The original proposal documents can be found via the following pages:
> MDD-IVDD communication 2012-540
> IVDD Regulation proposal 2012-541
> MDD Regulation proposal 2012-542
The final EU Commission text can be found here
> Read the final text
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 As the industry has evolved, the Directive has become outdated.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.
When is the In Vitro Diagnostics Directive changing?
The Regulation entered into force on May 25th, giving manufacturers five years to transition to the new IVD Regulation. The new rules will apply from May 2022 for IVD devices.
Use our Frequently Asked Questions document to learn more about the transition and the changes to the requirements.
Further details of transition can be heard in the IVDR webinar.
You can also download our Frequently Asked Questions document to learn more about the transition period and the new requirements.
Informative BSI white papers
How to best prepare for and implement the IVDR - Dos and Don'ts
This white paper from BSI guides you through the IVDR legislative changes. This useful paper provides a checklist, allowing you to see how the Regulation will impact on current manufacturer operations and what you need to consider before the Regulation comes into force, both during the transition period and after it is implemented. Co-Authored by Dr Gert Bos, former Head of Regulatory Affairs at BSI, and Erik Vollebregt, Partner at Axon Lawyers, the white paper is the most recent in a series from BSI to support you through the transition from the IVD Directive to the IVD Regulation.
The proposed EU regulations for medical and in vitro diagnostic devices
An overview of the likely outcomes and the consequences for the market, updated October 2015
To understand how the changes will impact the industry, and what this means for your business, download your complimentary copy of BSI's updated white paper. Authored by Dr Gert Bos, Head of Regulatory and Clinical Affairs at BSI, and Erik Vollebregt, Partner at Axon Lawyers, the white paper provides insight into the likely outcomes of the Regulations consequences for the market. Don't delay in understanding the consequences of these significant, mandatory changes on your business.
Changes to the way In Vitro Diagnostics are regulated in Europe
IVD Factsheet: for further information
The IVD Directive will soon be replaced by the IVD Regulation and this is a list of web links and documents that may be useful to address the regulations both now and in the future.
Develop your understanding with BSI training courses
BSI offers a range of training courses, suitable for those new to regulatory affairs through to those wanting to develop their knowledge and understanding on particular topics. See our IVD-specific courses below, or visit our training pages for more information.
Technical files and design dossiers for In Vitro Diagnostics (BSI Global site)
A required part of conformity assessment and CE-marking is the need for a Technical File (called a Design Dossier for high risk devices), which includes the collation of supporting information about your IVD device. Learn how to assemble this and other types of required information, so you can CE Mark your device in Europe. You’ll also learn potential changes that may impact your Technical Documentation under the proposed future IVDR.
Performance evaluation and clinical evidence for In Vitro Diagnostics (BSI Global site)
When placing an IVD device on the European market, you must demonstrate that it complies with necessary regulatory requirements through appropriate conformity assessment procedures. Learn how to plan for appropriate performance studies for your IVD device and gather required information and data needed for a body of clinical evidence under the proposed future IVDR.
Where can I find further information?
This transition page will be updated regularly with the latest facts. BSI will run a series of webinars and white papers to ensure we share valuable information with you regarding these significant changes.
The official non-BSI websites can also provide additional background and detailed information:
Competent authority, MHRA
If you have questions regarding the changes please contact your BSI Scheme Manager for initial questions.