01 May 2020
Posted in Medical Devices
IVDR delay unlikely as quality of new diagnostic devices become compromised
Following an announcement by MedTech Europe, requesting the European Commission to delay the implementation of the new In Vitro Diagnostics Regulations (IVDR) by a year;
Aliyah Farouk, Medical Device Analyst at GlobalData, a leading data and analytics company, offers her view:
“As the delay of the Medical Device Regulations (MDR) has taken full effect, attention is now on the In Vitro Diagnostics Regulations (IVDR), due to come into action in May 2022. MedTech Europe believes the time frame set for the implementation of the new regulatory system to be insufficient, considering COVID-19 disruptions. The IVDR comes with many stringent requirements, therefore a delay will ease the pressure on manufacturers as supplying diagnostics on the COVID-19 frontline becomes a priority. However, concerns are rising over the poor performance of numerous diagnostic products currently on the market.
“Fast track approvals for devices has been widespread since the COVID-19 outbreak with manufacturers getting exemptions from certain regulations. Many diagnostic companies have been attaining the CE mark certification for their devices as a rapid response to the pandemic, often self-certifying to meet the requirements. According to GlobalData estimates, over 200 COVID-19 diagnostic products gained the CE mark approval since the outbreak.
“The lax in regulations has made the EU a lucrative market for often faulty devices. The UK Government recently bought two million diagnostics kits for detecting antibodies which turned out to be ineffective. GlobalData expects an IVDR delay will therefore be unlikely as device quality takes precedence. As the IVDR increases the responsibility of manufacturers when it comes to the clinical use of their products, companies will likely be under more scrutiny to ensure regulations are effectively met.”