The new Regulation on in vitro medical devices (IVDR) will start to apply on May 26, 2022. For manufacturers, we want to highlight two crucial points. The first aspect concerns the transition periods: manufacturers can place their IVD compliant devices after May 26, 2022 under certain conditions and only until the respective (delete: different) different transition periods end (the so-called “grace period”). The second key information regards the characteristics and requirements under which manufacturers can place their devices on the EU market after IVDR date of application. Whereas the transition periods and the key characteristics of legacy devices were already known, the Medical Device Coordination Group just published a new Guidance with further specifications regarding IVD legacy devices. Specifically, the new document provides clarification on the concept of “significant changes in the design and intended purpose” under IVDR.
Key characteristics of legacy IVD medical devices
Up until the various deadlines specified in Article 110(3) IVDR, IVD legacy devices must have the following characteristics to be placed on the market as such:
- a valid certificate issued by a notified body under the Directive 98/79/EC on in vitro diagnostic medical devices (IVDD),
- a declaration of conformity drawn up before May 26, 2022, following the IVDD and for which the conformity assessment procedure according to the IVDR (contrary to the IVDD) requires the involvement of a notified body.
When the deadline comes, IVD medical devices cannot be considered anymore as legacy devices, even if they meet the two requirements described above. In addition, manufacturers cannot place legacy devices on the market anymore as soon as there are significant changes in their design or intended purpose after May 26, 2022.
How to assess significant changes in design and intended purpose
Significant changes would lead to new a notification, whereas non-significant would not. However, the manufacturer is responsible for proving that the changes to the device affect neither the design nor the intended purpose. The manufacturer must document such changes and made the documentation available to Competent Authorities when requested. Moreover, a Notified Body will verify such changes and their implementation. This verification aims to assess if the changes can be considered non-significant and, thus, no new notification is necessary.
Which changes do not concern the design or intended purpose?
Changes not concerning the design or intended purpose are changes related to the manufacturer’s organisation (administrative changes) or the manufacturing process. Such amendments include:
- changes of the manufacturer’s name, address, or legal form;
- changes concerning the authorised representative;
- relocation or addition of new manufacturing sites;
- changes of the supplier of material, ingredient, or component;
What are changes in the design or intended purpose?
When placed on the market as legacy devices, the benchmark to determine the design and purpose of an IVD medical device is still the Directive (IVDD), not the upcoming VDR. While IVDD does not specify the “design”, it defines the “intended purpose” as “the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use and/or in promotional materials”. To understand whether a change to the design or intended purpose is significant, this MDCG Guidance provides an Annex. This Annex is structured in form of questions. If the answer to every question leads to “non-significant change”, then a change is not considered as significant.
Some examples of non-significant changes in the design or intended purpose are:
- changes related to corrective actions assessed and accepted by competent authority;
- correction of spelling errors or editorial changes;
- updates of the information to be supplied with the device if required by law other than IVDR.
Some examples of significant changes to the intended purpose:
- extension of the intended purpose (e.g., additional functions, extension of the target population, additions of what is detected or measured, etc.);
- any other major change of the intended purpose (change of essay type, intended user, specimen type, etc.)
Some examples of significant changes to the design:
- changes that alter the device’s operating principle;
- changes that adversely affect the safety or performance and negatively affect the risk/benefit ratio of the device
Changes to software, to an ingredient or material, and sterilization
Some significant changes to the software of an IVD device are new or major changes to the operating system or any component, the addition of a new database with new content used for the test results, and similar.
Significant changes to an ingredient or material concern changes of an ingredient or material that is essential for the operating principle of the device, and that negatively affect safety or performance as well as the risk/benefit ratio of the device.
Eventually, significant changes to sterilization are amendments to the sterilization method and in the design or packaging when negatively impacting the sterility of the device.
You can find the full text of the MDCG Guidance in our dedicated Library – IVDR- MDCG.
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