Keeping up with regulatory changes: EU MDR and IVDR
Web content editor Ian Bolland discussed with Angela Brown, director of regulatory affairs at ICON, what manufacturers can learn from Medical Device Regulation (MDR) preparations, the effect it will have on the In Vitro Diagnostic (IVD) landscape, and why preparation is the key to success.
Most recently, the EU introduction of MDR has been postponed for one year to 26th May 2021 due to the global Covid-19 pandemic, and many manufacturers might be wondering if the In Vitro Diagnostic Regulation (IVDR) will also be delayed. Brown explained how the disruption of the present pandemic is being realised by the medical device industry, with IVD manufacturers being no exception to this.
Yet as global processes change in order to treat Covid-19, there is an overwhelming need for industry to provide the basics, including personal protective equipment, medical devices and IVDs. Although these essentials are available, supply does not meet the immediate demand.
To specifically address Covid-19, the European Commission is allowing individual member states to temporarily permit access for products that have not met the required conformity assessments to apply the CE mark. These are temporary measures and are only valid during the pandemic.
Prior to the Covid-19 outbreak, Brown presented at the Outsourcing Clinical Trials meeting at Medical Devices Europe in Munich in February. Here, she covered the urgent need for manufacturers to contract with a notified body, prepare compliant documentation, and establish a process for post-market activities.
Brown felt that IVDR manufacturers were behind in terms of preparation, were struggling, and had a lot of work to do to bring their existing products that are already on the market into compliance. She said: “They may have documentation that’s either outdated or not up to the current standards to meet the new requirements or the better explained requirements stated in the IVDR that wasn’t there previously. Although IVD manufacturers had awareness of these requirements from the IVD Device, IVDR gives more clear and defined steps to complete the requirements.
“I feel they have all of the information they need to bring their technical documentation into compliance but they’re struggling because they just don’t know how to put it all together.”
Brown explained how she hopes to see an increase in the amount of IVD notified bodies and urges manufacturers to start working with one as soon as possible. Currently only 10% of products require notified body involvement prior to being brought to market, but this will rise to 90% under the new regulation. However, the Covid-19 stay-at-home orders directly impacts further designations of additional IVDR notified bodies by limiting the necessary face-to-face required audits.
Brown felt that IVD manufacturers should be working towards obtaining or co-ordinating with a notified body to set expectations and timelines as well as determining their EU product portfolio. These efforts should be completed with a sense of urgency as manufacturers may already be behind: “It’s a lot of work they have to do. Many manufacturers have never had their documentation reviewed or audited by a regulatory agency in order to meet the market compliance requirements, so they are learning as they start working with their notified body.”
There’s a key difference for IVD manufacturers compared to those who prepared for MDR, as Brown explained they had the benefit of needing notified body involvement for most devices placed on the EU market, while IVD manufacturers haven’t since the majority of the products are self-declared.
In the worst case scenario, what are the consequences if manufacturers haven’t adequately prepared for IVDR’s implementation? “What we are anticipating is that notified bodies that are designated for the IVDR will be significantly reduced from the notified bodies that are available for IVDD,” Brown explains, “and there’s potential for products to be removed from the market.” This could lead to concerning knock-on effects.
Amid uncertainty and an ever-changing regulatory landscape, Brown recommends that IVD manufacturers should continue with current plans to certify under IVDR according to the 26th May 2022 date.