Welcome for Euro IVD amendment

Head of regulatory affairs at InnoScot Health, Elaine Gemmell commented after the European Council agreed an amendment to its In Vitro Diagnostic Medical Device Regulation legislation.

Manufacturers must now provide six-month notifications to relevant authorities, health institutions if they foresee interruption in the supply of devices which may result in harm to patients.

The Council move also addresses the requirement for manufacturers to provide information to the European database on medical devices (EUDAMED) about their products to six so-called ‘module’ registration categories.

Modules include: ‘actor’ registration, encompassing all economic operators along the supply chain; device registration; certificates gained and relevant certification authorities; clinical investigations and performance studies; vigilance and post-market surveillance; and market surveillance – covering non-compliant products and corrective actions taken.

Previously, producers were not required to register their devices on EUDAMED until all six modules details were available. Now, they will be required to register information in any modules for which they currently hold details.

Said Gemmell: “This is a positive change aimed at preventing interruption of supply of IVDs due to changes in the regulations.

“Extending the deadline for transitioning to the new system while taking steps to avoid shortages of critical IVDs is to be welcomed amid recurrent concerns that products were not transitioning quickly enough to IVDR under the previous deadlines."

She added it was welcome to see the European Commission’s proposals for updating the IVDR deadlines endorsed by the EU Council after agreement was reached with the European Parliament. This in turn would give manufacturers more time to recertify their products, she stated.

However, she cautioned: “At the same time, it is clear that much work is yet to be done, and it has to be said that this fourth extension represents a temporary solution – particularly considering a number of products which are currently on the market are yet to comply with the new IVDR rules.

“We also echo others’ concerns over challenges persisting and practical solutions being required rather than further extensions.”

The amended regulation stipulates that class D devices need to come into conformance by 31 December 2027, class C devices by 31 December 2028, and class B and class A sterile devices by 31 December 2029.

Currently, IVDs compliant with the EU in vitro diagnostic medical devices directive (IVDD) can be placed on the Great Britain market  until the expiry of certificate or 30 June 2030. General medical devices compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the IVDR can be placed on the Great Britain market up until 30 June 2030.