The IVD industry is about to undergo significant change. The final text of the European IVD Regulation is undergoing legal-linguistic review; this legislation will replace the current IVD Directive (98/79/EC), and brings with it an increase not only in the requirements of manufacturers wishing to sell devices in Europe, but also in the number of manufacturers that will be required to use a Notified Body to do so.
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, once adopted by the European Parliament and by the Council, replaces the existing three Medical Device Directives.
The original proposal documents can be found via the following pages:
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 As the industry has evolved, the Directive has become outdated.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 Diagnostic Directive changing?
The Council has planned to approve the agreement at ministers' level in September 2016. Following their legal-linguistic review, the draft regulation will be then adopted by the Parliament and the Council, probably in early 2017.
The new rules will apply 5 years after publication for IVDs. 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.
Changes to the way In Vitro Diagnostics are regulated in Europe
IVD Factsheet: for further information
The IVD Regulation will bring significant changes. This is a list of web links and documents that may be useful to address the Regulation.
BSI Webinar programme will enable you to prepare for changes:
The role of the Person Responsible for Regulatory Compliance under the future Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
The new Medical Device and In Vitro Diagnostic Regulations will be published in the coming months. One of the novelties introduced as part of this major regulatory change in Europe is the concept of the Person Responsible for Regulatory Compliance. This was inspired by the pharmaceutical “Qualified Person” role and has been dramatically reviewed and diluted down since the original draft regulation proposal. However, the basic principles remain.
This webinar will discuss the concept of the Person Responsible for Regulatory Compliance as described in the current draft version of the Medical Device Regulation and the IVD Regulation, provide a brief background on the Pharma Qualified Person duties and how this concept is translated into the Medical Device and IVD world, and will cover some of the practical aspects of the implementation of this new requirement for manufacturers.
The In Vitro Diagnostic Regulation - Changes to the IVD regulatory landscape
The upcoming changes to the regulatory requirements for IVDs will require a thorough understanding from manufacturers to ensure a smooth transition from the IVD Directive to the IVD Regulation. Robust and timely plans should be made, and to do so, manufacturers need to be aware of the magnitude of changes and the activity that lies ahead.
This webinar discussed the key requirements that IVD manufacturers will need to be aware of, highlighting the areas that are most changed vs. the current IVD Directive. There is an explanation of the current position and expected timelines, and acknowledgement of the role of the Notified Body, with emphasis on the next steps for manufacturers.
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.