Procedures allowing medical implant manufacturers to demonstrate compliance with MRI safety regulations

Short Name: MIMAS, Project Number: 17IND01

Procedures allowing medical implant manufacturers to demonstrate compliance with MRI safety regulations

Image showing radiologist examining a patient's scan results

In the EU alone, the market for medical implants is worth 3 billion Euros. Of the 50 million European citizens carrying such devices, the majority will at some point receive an MRI scan (Magnetic Resonance Imaging). Due to MRI magnetic field and radio wave interactions with some implants, product compatibility is a key consideration for patient safety.

Scanning interference hazards could be further reduced with updated regulations, and currently time-consuming compliance testing methods discourage manufacturers from creating new products for the implant market.

 

This project developed the test methods needed to demonstrate implant compatibility with MRI scanning for improved patient safety.

By improving models of human subjects with implants, and validation of computer modelling by comparison with test implant measurements, the project results feed into new and existing international standards for MRI safety regulations.

With an additional, simpler compliance-checking process for small implants (< 10 cm), many European manufacturers will benefit from the outcomes of this project.

 

MRI‐Related Heating of Implants and Devices: A Review
2020

Journal of Magnetic Resonance Imaging

Participating EURAMET NMIs and DIs

INRIM (Italy)

NPL (United Kingdom)

PTB (Germany)

Other Participants

Istituto Ortopedico Rizzoli (Italy)
ZMT Zurich MedTech AG (Switzerland)

Information

Programme
EMPIR
Field
Industry
Status
completed
Call
2017
Duration
2018-2021
Project website