Final Draft Text of IVDR now published
The IVD industry is about to undergo significant change. The final text of the European IVD Regulation is published; 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:
The final Februrary 2017 EU Commission draft can be found here
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 As the industry has evolved, the Directive has become outdated.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, expected in May or June 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.
Informative BSI white papers
White paper: 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.
Download your copy now.
White paper: 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 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:
Roles and responsibilities in the Medical Device and IVD Regulations
The new Medical Device and In-Vitro Diagnostic Regulations are expected to be adopted in the first half of 2017. Within the new Regulations articles 10-15 outline the roles and responsibilities of the various actors involved in the manufacture and supply of products into Europe.
This webinar will help you to consider what actions you need to start now to be prepared for the change in requirements; the webinar will outline the actions required, for each of the roles outlined in the new Regulations.
Post Market Surveillance and Vigilance - do you know the requirements?
The new Medical Device Regulation is expected to be adopted in the first half of 2017. The Regulation contains significant changes in requirements in the post-market area, including PMS planning and implementation, vigilance reporting and handling field safety corrective actions.
This webinar will help you to consider what actions you need to start now to be prepared for the change in requirements; the webinar will allow you to start planning how to meet the new requirements in this area.
Listen back to our informative webinars
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.
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
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
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.