The medtech industry “remains concerned” new EU IVD regulations will not be workable under existing infrastructures, according to MedTech Europe.
The European trade association said medical technology companies will welcome the IVDR (In Vitro Diagnostic Regulation), which is set to come into play on 26 May 2022.
But, in a statement, the trade association also announced it is “raising the alarm” after progress in implementing these regulations was halted earlier this year due to the Covid-19 pandemic.
Many of the critical building blocks needed to implement new regulatory policies in Europe — including guidance documents, EU reference laboratories and common specifications — do not currently exist, according to MedTech Europe.
It also claimed notified bodies, which assess whether manufacturers and their medical devices meet European regulations, must be re-designated due to the “considerably strengthened requirements” that will come with the new IVDR.
Serge Bernasconi, CEO of MedTech Europe, said: “The diagnostics industry continues to be committed to helping Europe combat Covid-19 and works towards recovery from the crisis.
“However, the pandemic impact on the IVDR implementation has been considerable, and this must be neither underestimated nor ignored.
“MedTech Europe and the diagnostics industry are ready to fully engage in discussions with authorities and stakeholders to find workable solutions, and make the implementation of the new IVD framework successful.”
New EU IVD regulations
The EU’s new MDR (Medical Device Regulation) was set to become part of European Union legislation in May 2020, with the IVDR scheduled to follow suit two years later, in May 2022.
Both entered into their respective three- and five-year transition periods after being adopted by the EU on 26 May 2017.
However, while the implementation of the MDR was recently delayed by an extra year until May 2021, due to the impact of the Covid-19 crisis, the start date for the IVDR has not been changed.
MedTech Europe said the pandemic has shifted the focus of authorities in EU member states, laboratories, health institutions and IVD manufacturers away from implementing these new regulations in 2022.
The trade association has therefore encouraged an “immediate dialogue” with stakeholders to ensure the public health challenge is addressed, and IVDR implementation activities are adjusted appropriately.
MedTech Europe also published a paper on 9 July outlining growing concerns over this within the medical technology sector.
