The National Standards Authority of Ireland (NSAI) expects approval to carry out certifications according to the new EU regulations for medical devices by the middle of the year.
The new In Vitro Diagnostics Regulation (IVDR) oversees devices that use biological samples to make a diagnosis, such as B. Pregnancy or diabetes tests. It will come into effect next month.
It requires inspectors – independent organizations known as notified bodies – to be appointed by the European Commission to conduct assessments to certify devices for use.
These include new criteria for risk-based assessment of devices, increased communication between Member States and stricter post-market surveillance to monitor how devices are used in practice.
Officially, the rules will come into effect next month, but the transition periods for various devices have been extended by several years depending on the risk level.
“We are on track for deportation this summer, no confirmed date yet,” said an NSAI spokesman.
However, the process of designating notified bodies under the new regulation has been criticized by the medical device industry as being too slow.
Currently, only six Notified Bodies have been designated, raising concerns that there will be a lack of capacity across Europe to certify equipment under the new regime. Under the old regulations there are 19 notified bodies.
The IVDR rules are due to apply from May 26, but the European Commission has extended the transition period and staggered the deadlines for various devices, with some getting an extension to 2028.
“Member States, manufacturers and Notified Bodies must now use the additional time to build the necessary capacities and manufacturers must prepare to adapt to the new requirements.
“There is no time to rest,” said EU Health Commissioner Stella Kyriakides at the time.
IVDR has a sister regulation called the Medical Device Regulation for all other devices for which the NSAI has been designated.
https://www.independent.ie/business/irish/national-standards-authority-to-get-eu-medtech-certification-approval-41557951.html National Standardization Agency to obtain EU Medtech Certification approval