While every In Vitro Diagnostics brand journey, mission and merchandise are different, the regulatory compliance efforts and the major challenges that the IVDR transition poses are a shared experience.
On Wednesday 12th of April, during the IVDR Roundtable organized by Obelis Group, Sandra Ferretti, Chief Compliance Officer at Obelis Group and Marta Carnielli, IVD Technical Officer at TÜV SÜD, discussed the best practices to avoid market disruption and allow a smooth IVDR transition.
“One of the biggest questions that we continually get from manufacturers is, how long it takes to select the right notified body?“ said Marta Carnielli, who works for TÜV SÜD, one of the few designated Notified Bodies under the new In Vitro Diagnostics Regulation (IVDR). “The IVDR demand is higher than the Notified Bodies. While selecting the right NB for your company might be one of the most important steps to selling your products in Europe, the progress on Notified Body designation continues to raise IVDR capacity concerns. For the moment, there are six NB, hopefully, to become nine soon. My advice to IVD companies is to hurry up and choose wisely, as it is a lengthy process with a limited number of experts available to support you.”
Regarding Regulatory infrastructure & guidance documents, Marta Carnielli highlighted that critical guidance is missing and implementing acts need to be approved by the EU Commission in the next quarter.
Sandra Ferretti chimed in, “Another challenge is the EUDAMED database. As of today, it hasn’t been used regularly as some modules and functionalities need to be added. In addition, even though manufacturers have access to the database, it doesn’t guarantee an easy navigation and device registration due to its complexity. Finally, especially for non-EU manufacturers, some concepts like the UDI number might be challenging. So, make sure you find the right stakeholders to support your compliance efforts and familiarize yourself with the new concepts that IVDR brings forward.”
“The UK and Switzerland follow their own regulatory framework. Non-UK based manufacturers need to appoint a UK RP, and non-Swiss manufacturers a CH-REP. Many manufacturers are still unaware of this need, and it’s crucial to ensure that your business access to the market is not held up due to failure to meet legal and other requirements.”
With the IVDR DoA being 43 days away, whether you are a manufacturer that needs to comply with the IVDR or a brand that wants to expand in the UK and Swiss markets, we hope you found this conversation helpful.
Thank you for joining us & stay tuned for the upcoming webinars.
To watch the replay of this Roundtable discussion on IVDR, click here.