With so many IVD firms still to submit, the deadline is now closer than you might realise…
I’ve seen lots of articles, in the trade press and IVD forums, about the fast-approaching EU IVDR 2017/746 deadline. So when I was asked to bring my previous IVDR blog up to date, I feared that our IVD readers were already well in the picture and likely to be merely anaesthetised by more of my IVD ramblings. However, having read in a recent survey that over half the population of IVD companies sampled felt that they needed more guidance before embarking on their IVDR journey, I realised that I could put my knowledge to good use after all.
IMed’s Business Development team further informed me that many IVD clients canvassed to book their IVDR space in our pipeline, say that they are ‘still scoping out’ their IVDR task. I found this equally alarming! With notified bodies already jammed up and just 11 months to go I was immediately galvanised into determining where the confidence and knowledge gaps are and how I can help.
The transition date is less than a year away and the EU commission is showing no signs of blinking first, when it comes to a possible extension. Let’s accept we have a job to do and set about breaking down exactly what needs to be done.
Having consulted on IVDR for over 2 years now, I’ve had the opportunity to conduct quite a few gap assessments of a variety of Quality Management Systems (QMS) and IVD device technical files. Fortunately, I’ve been able to spot trends on where the new regulations give us the most work to do and the many areas of the IVDR, which Economic Operators (Manufacturers, Authorised Reps, Importers and Distributors) might be struggling with.
In the coming weeks I’m going to use this experience to guide you through the IVDR from A to Z. No information overload; I’ll simply go through all the necessary sections individually – in nice, digestible chunks – and you can by all means email me if you want further help.
Whether you are new to IVD regulation or IVDR, or are mid-way through your current transition, I’m sure you’ll find some helpful tips and advice which are relevant to your task and will point you to the most efficient route to the regulatory finish, whilst still ensuring that your IVD device remains as safe and effective as possible for patients.
So, broadly speaking, the IVDR consists of the following elements:
I know that the number of sections initially seems quite daunting, but it’s more straightforward than it looks;
General Performance Requirements
Split into 3 separate chapters, there are now 20 requirements, as opposed to just 13 in the current IVDD. Chapter I is more focused on risk management, i.e; must demonstrate that the benefits outweigh the risks; must reduce risk as far as possible. Chapter II calls for more detailed information concerning the analytical and clinical performance of the device. Chapter III contains 108 sub-paragraphs regarding the device label and instructions for use.
New to the IVD industry in the EU, the manufacturer must sufficiently demonstrate that their device can achieve the intended clinical benefit and safety, when used as intended. This evidence is now required in accordance with a Performance Evaluation Plan and collated as a report. This will need to be continuous during the lifetime of the device.
With the requirement for Post-Market Performance Follow-up, the scope for Post-Market Surveillance has been broadened. As a result, class C and D IVDs must have an annual update, as part of a Periodic Safety Update Report (PSUR). Class A and B IVDs only need an update to reflect a change.
According to the new EU IVDR Article 30, the databases established under the new EU IVDR will contain comprehensive data on the devices themselves, including the Unique Device Identification (UDI) data, as well as data on all the economic operators associated with those devices. They will also contain data on the Notified Bodies and the certificates they issue AND data on performance studies conducted in Europe, as well as vigilance and post-market surveillance data.
Any technical files which you have for a legacy device will need to be dusted off and revised, fairly extensively. Annexes II and III provide a very detailed set of requirements for completing this activity. Compared with what currently exists for a device under the IVDD, there is more needed under IVDR. Examples include UDI labelling, a thorough intended purpose, GSPR, a thorough documentation of the clinical evidence and expansion of requirements for PMS.
In order to bring your QMS up to speed with the IVDR requirements it is recommended to conduct a gap assessment of your current documentation, as there are several elements which will very likely require revision, or in some cases; new procedures for the first time. Examples include: supplier control, PMS, risk management, UDI labelling and vigilance.
These are just the highlights, as I said earlier, and I’ll get into further detail on each part of the regulations in future blogs. So please do look out for my IVDR blog series to follow, where I’ll expand on these key areas individually.
Author: Stephen Quinn IMed QA and IVDR Consultant
Article written by Medilink Midlands member IMed Consultancy. For further information please contact: Alison Mills, Business Development at email@example.com.