In Vitro Diagnostic (IVD) Medical Device means any medical device intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, to provide information regarding a physiological or pathological process or state, concern congenital physical or mental impairments, concerning the predisposition to a medical condition or a disease, to determine the safety and compatibility with potential recipients, to predict treatment response or reactions, or to define or monitor therapeutic measures.
IVD medical devices can be a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software, or system, whether used alone or in combination. For example, the most common IVD medical devices that we all are aware of are the testing kit for Covid-19, Pregnancy Test Kit, and a glucometer.
There was a “fallout” due to the breast implant scandal, where a manufacturer deliberately used industrial-grade silicone to make breast implants. Hence, moving from a Directive to a Regulation was essential. The aim was to ensure broad scope of protection, more effective implementation of the rules, and to provide transparency.
The scope of the IVDR regulation has not expanded notably. The range of products covered by the IVDR has remained the same; however, the depth and the expectations for the documentation and review have significantly increased.
REGULATION (EU) 2017/746 (IVDR) aims to ensure a high level of protection of health of patients and users by setting high standards of quality and safety for in vitro diagnostic medical devices.
The most significant change in IVDR is the classification of devices. Where the devices are divided into two lists i.e., List A and List B in IVDD, the devices in the IVDR are divided into four classes i.e., Class A, Class B, Class C, and Class D. Class D devices have the highest risk while Class A devices have the lowest. The devices are further categorized as devices for near-patient testing, devices for self-testing, and companion diagnostic devices.
IVDR has been effective since May 26, 2017. As it is applicable within the territory of the European Union, it is necessary for any medical device manufacturer that is going to distribute its products in the European market to comply with the appropriate regulations.
However, for medical devices that are already present in the market, special transition periods are provided. These devices can be defined by two terms: “Legacy Devices” and “Old Devices”. So, first let’s get a clear understanding of the terms.
Legacy Devices are the devices covered by a valid EC certificate issued by a notified body in accordance with Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) prior to 26 May 2022; or the devices for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with the IVDD and for which the conformity assessment procedure pursuant to the IVDR (contrary to the IVDD) requires the involvement of a notified body.
The devices that were placed on the market or put into service before 26 May 2022 in accordance with the IVDD or the applicable national rules before the IVDD had become applicable and which are still on the market or in use after 26 May 2022.
So, now that you have understood the terms. Let’s move forward with the Transition periods: –
For devices covered by a valid EC certificate issued in accordance with the IVDD (i.e., devices listed in Annex II IVDD and devices for self-testing), prior to 26 May 2022, the transition period ends on 26 May 2025.
If placed on the market before 26 May 2025, those devices may continue to be made available until 26 May 2026.
As per the class of the device:
Devices for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with the IVDD and for which the conformity assessment procedure pursuant to the IVDR (contrary to the IVDD) requires the involvement of a notified body, the transition period ends on:
Even though the device may continue to be made available in the market as per the timelines, still there are some of the essential requirements of IVDR for legacy devices and old devices that needs to be met.
In addition to the requirements set out above, also other IVDR requirements should apply to ‘legacy devices’, provided that those requirements relate to post-market surveillance, market surveillance, vigilance or registration of economic operators and devices and support a well-functioning vigilance and market surveillance system as well as proper registration of economic operators and devices.
Regarding ‘legacy devices’ covered by certificates issued under the IVDD, the notified bodies that issued the respective certificates conduct the ‘appropriate surveillance’, which essentially is a continuation of the previous surveillance activities under the IVDD. In the framework of their surveillance activities, notified bodies will take into account the new requirements that apply to manufacturers resulting from the transitional provisions.
While this new regulatory environment can improve patient satisfaction and the accuracy of treatment decisions, in the long run, the development of in vitro diagnostic devices will not be as smooth as it once was. From stricter documentation processes to the involvement of Notified Bodies and the associated additional costs, stringent compliance requirements and guidelines will place a heavy burden on IVD manufacturers.
Manufacturers of in vitro diagnostics who wish to sell their products in the European market, need to fulfill the requirements of IVDR to be fully compliant, and now will be the time to get ready. If the preparation is put off until the end of the transition phase, there are chances of experiencing many challenges. So, start now and if you need any assistance, contact us, we would be happy to cater to your needs.
Author: Divyanshi Jethva
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