The European Union’s In Vitro Diagnostics Regulation (IVDR) is set to take effect May 26, 2022, but a recent effort to amend the transitional provisions of the new regulation may bring some relief.
The Council of the European Union has adopted the European Commission’s proposal to allow for extended transitional provisions that, once published as EU law, will support the continued availability of devices currently on the market to patients, hospitals, laboratories, and other users, according to MedTech Europe.
“In order to address the shortage of notified body capacity more broadly, the transitional provisions will be extended by legislators specifically for devices that have to undergo a conformity assessment involving notified bodies for the first time under the IVD Regulation. The European Commission proposal therefore allows manufacturers without access to a notified body to continue marketing their tests for 3 to 6 years following the IVD Regulation’s date of application (the length of time depends on the device risk class),” according to the MedTech Europe statement provided to MD+DI.
Manufacturers should “draw up the EC Declaration of Conformity under the IVD Directive before the IVD Regulation date of application for any devices where they want to use the extended transitional provisions,” the association stated. “This is one of the main conditions for using the extended transitional provisions.”
And “manufacturers should be aware that devices cannot remain under the transitional provisions if they have significant changes to device design and intended purpose.” If there are significant changes, manufacturers should “drive any major changes before the date of application or plan in sufficient timelines for making changes and contracting with a notified body to certify the updated device under the IVD Regulation.”
To help characterize what “significant change” means for IVDs, the Medical Devices Coordination Group is developing guidance expected to be published before the end of March, MedTech Europe explained.
However, any device that is considered “new” and that “falls under class B, C, D, or A sterile will need to be certified under the IVD regulation after the date of application in order to be placed on the market.” Where possible, manufacturers “should anticipate the development of the new product and contract with a notified body to certify it under the IVD Regulation.”
Notified bodies have been quite busy given last year’s Medical Device Regulation coming into force as well as preparations for the IVDR. “Given the current lack of notified body resources and the impressively greater amount of certification work that notified bodies need to do in total for the IVD sector under the IVD Regulation relative to the IVD Directive, manufacturers should consider planning certification work when access to a notified body becomes possible rather than waiting until late in the transitional provisions,” MedTech Europe advised. “It should also be considered that the time to contract with a notified body, complete certification work, and market the device can be 12-24 months or longer.”
In addition, the number of IVDs for detecting SARS-CoV-2 have also complicated the IVDR roll out. As a potential solution, the Medical Devices Coordination Group is expected to publish common specifications for SARS-CoV-2 under the IVDR in the first quarter of 2022. “These will be important for manufacturers to consider,” MedTech Europe explained in the statement. “When new variants are detected, the manufacturer is obligated to monitor the performance of their devices on any variants of SARS-CoV-2 and to take action as appropriate, including updating IFUs and technical documentation, issuing FSCAs and reporting any incidents.” They also advise that IVD manufacturers consult MDCG notice 2021-7.
When MD+DI asked whether MedTech Europe expects a delay in the new IVDR, we were referred to the European Commission. “We note that the legislators agreed to extend the transitional provisions rather than postpone the IVDR date of application,” the association stated.