The ‘New Year’s resolution’ is a tradition almost all of us are familiar with, in which a person resolves to accomplish a personal goal, continue good habits or change undesirable ones all with the intention of self-improvement. A study of over 800 million activity data points on the exercise platform Strava found that today, January 19th, is the most common day for a New Year’s resolution to be abandoned (1). If you are reading this acutely aware that you didn’t make your run this morning, or with the leftover Christmas chocolates in hand, you can therefore be safe in the knowledge that you are not alone – and there’s always next year! However, for manufacturers and healthcare professionals there is one resolution that can’t be dropped in 2022 – readiness for IVDR.
The new In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR) is a Regulation from the European Commission intended to bring European (EU) legislation in line with recent technical and legal advancements in medical science. The Regulation “improves clinical safety and creates fair market access for manufacturers and healthcare professionals” (2). 2022 is the year that the EU will begin to enforce the transition from the old Regulation to IVDR, with an end date for readiness of May 26th 2022.
For medical device manufacturers, this date represents the deadline after which only in vitro devices (IVD) which are CE marked according to IVDR may be placed on the EU market for sale. All IVD products and solutions are affected by this resolution. Moreover, whilst the previous Regulation (IVDD 98/79/EC) makes significant exemptions for so called ‘in house’ laboratory developed tests (LDTs), IVDR does not.
LDTs by definition are manufactured and used within the same healthcare setting or institution. They are not marketed or sold, and do not bear CE marking (3). Under IVDD, LDTs were exempt from regulation excepting general safety and performance criteria. IVDR includes a very specific in-house exemption that allows for the manufacture, modification, and use of LDTs on a ‘nonindustrial scale’ to meet the needs of a given patient group if ‘an equivalent device available on the market cannot already meet these needs at the appropriate level of performance’ (4). There will also be several new standards for laboratories to make in terms of quality management frameworks. Test send out services (TSO), where a sample is sent to a lab and a result is sent back, are treated under IVDR as ‘Distance Sales’ and are as such subject to the same regulatory treatment as a commercial product (on the market for sale) (5). It is anticipated that very few LDTs will meet the exemption requirement. As such laboratories using LDTs (or those offering a TSO) should be prepared for IVDR, either by readying themselves and their LDTs for classification, or seeking alternative commercially available solutions.
Here To Help
Most people would agree that resolutions can be much more successful when appropriately and expertly supported. Much like how a person looking to improve their overall fitness might seek out a personal trainer, Yourgene Health are on hand to support laboratories who have IVDR readiness as a goal for 2022.
The Yourgene “IVDR Project” was initiated with the express goal of ensuring we are able to continue to supply our key products into IVDR regulated territories from May 2022. The project also considers other ways in which we can support our laboratory partners in the transition period and beyond. The implementation strategy includes but is not limited to:
- New risk-based classification system
- Consequent modified conformity assessment processes
- Designated IVDR notified body (BSI)
- ISO13485 compliant Quality Management System
- Re-Compilation of technical documentation
- Declarations of Conformity under the IVDR Certificate
At Yourgene Health we want to support our trusted laboratory partners across all their goals and resolutions for the year ahead, including helping you prepare for IVDR. See [here] for our IVDR Readiness Statement. Get in touch with our trusted Regulatory Affairs team using the contact form [here] for advice on we can help you be IVDR ready.
1: Inc article
2: European Commission article
4: AACC article