The Irish NSAI expects approval to get the EU MedTech Certification to carry out certifications under new EU criteria for medical equipment. This would be by the middle of the year. NSAI stands for National Standards Authority of Ireland.
The European Commission must appoint inspectors to conduct assessments and certify devices for use. In fact, they do so according to new legislation. The new In Vitro Diagnostic Regulation (IVDR) regulates devices that use biological samples to make diagnoses. You can think of pregnancy and diabetes tests, for example. It will go into effect next month. It requires the European Commission to appoint inspectors – known as notified bodies – to carry out examinations in order to certify devices for use.
This includes a number of new criteria, such as:
- updated risk-based criteria for evaluating devices,
- improved communication across member states, and
- more stringent post-market surveillance to track how gadgets are used in practice.
Officially, the laws go into force next month. However, the transition periods for specific devices have been extended by many years, depending on their danger level.
“We’re on schedule for designation this summer, but there’s no specific date yet,” an NSAI spokesman said.
Slow Process of the Selection of Notified Bodies
On the other hand, the medical device sector has criticized the new regulation’s process for selecting notified organizations as being excessively slow. Consequently, there are only six notified bodies as of yet. This raises concerns that there may be a capacity shortage in Europe to certify devices under the new framework. Under the prior rules, there were 19 notified bodies.The IVDR rules will take effect on May 26th, however the European Commission has delayed the transition period, staggered the dates for specific devices, and given some of them a 2028 extension.
“Member states, manufacturers and notified bodies must now use the additional time to build up the necessary capacities, and manufacturers must prepare to transition to the new requirements“.
“There is no time to rest,” EU health commissioner Stella Kyriakides said. The Medical Device Regulation, which is designated for all other devices, is a sister regulation to the IVDR.
Irish NSAI Expects Approval to get EU MedTech Certification: sources, links and download
- Jonathan Keane from Independant.ie
- Medical Device New Regulations, Official page from the EU
- Download MDR, available in 24 languages
- French & German warning: EU must extend MDR transition period (Blog)