3 Months to the IVDR Deadline, are you ready?

26th May 2022 sees the implementation of the new EU IVDR, bringing with it one of the most significant changes to medical device regulation in 24 years.

In our many conversations with clients about the new EU IVDR the question everyone asks is; “Is it really going to happen in 2022?”  The answer is yes.. at least partially.

Throughout the first few months of 2022 we have seen speculation on the date of application being pushed back with the European Commission’s proposal to amend the transitional provisions, now adopted, plus a longer list of harmonised standards but the key takeaway is, despite the breathing space these updates afford, the transition deadline of 26th May 2022 remains for aspects of the regulation.

So, what is most urgent?

Our interpretation of Article 112 on the repeal provisions mean that certain requirements of the existing Directive will remain in force, notably, requirements for Performance Evaluations.

The requirements of the Directive for Performance Evaluations will remain in force until either;

a) 26th May 2022 or

b) the date of publication in OJEU of the full functionality of Eudamed + 6 months.

In addition, according to article 113, Articles 56-65 of the IVDR will also come in to force by the current Date of Application, 26th May 2022.

What you need to consider for your IVD development

• For CE marked devices already on the market / put into service – are there any substantial changes planned?  How would you deal with substantial changes that are unplanned?
• Have you got any new devices planned for launch? If so, they will need to be CE marked before 26th May 2022 to avail of the amended transitional provisions.
• For IVD devices in development – what are the timelines for your conformity assessment?  Do they go beyond the date of application?
• Clinical evidence and performance evaluations – do you understand the transitional provisions?  While the requirements cannot be implemented without EUDAMED being ready, there are others that can and will be. You still need to document your performance evaluation and prepare the documents required of Annex XIV for interventional and high-risk studies, even if you are not conducting performance evaluations in line with all of the requirements of the new regulations.
• Engaging with a notifying body; has this been factored into your timelines?
• Are you prepared for a Quality Management System (QMS) assessment?  This is part of the process of CE marking, another QMS inspection will be undertaken to ensure that the requirements have been incorporated.
• Do you have processes for post market surveillance and vigilance in place?

In summary, although the route to compliance has simplified slightly with more harmonisation of standards, and delays to implementation of certain requirements; there is still much to be done to ensure that your devices comply and remain on the market.  It’s imperative that you act now to avoid any disruption to supply or launch of your IVD products.

Keep updated with our IVDR Series

We will walk you through some of the main impacts you need to prepare for with our IVDR series over the coming weeks; meanwhile you can subscribe to be alerted of any updates as and when we share them, or connect with us on social media.

Not sure where to start? Our consultants are on hand to support you in navigating this complex and changing landscape of regulation, please get in touch for an introductory call to discuss your requirements.