Medical Devices

All devices identified for medical purposes are required to meet the requirements specified in the EU Medical Device Regulation (MDR) 2017/745 or the UK Medical Devices Regulations 2002 and is applicable for all intended environments of operation including Professional Healthcare environments (e.g. hospitals) and Home Health Care environments (e.g. public spaces, transport) and Special Environments such as industrial or military locations.

EMC is a vital component in meeting the requirements of the MDR and forms a key part of the technical documentation, ensuring the device has a legal right to be on the market.

The applicable standard for medical EMC is IEC 60601-1-2 (currently Edition 4.1). Compliance with this standard provides a "presumption of conformity" with legal requirements. 

Under the EU MDR 2017/745 and UK MDR 2002, electrical medical devices are classified by their risk to the patient. For IEC 60601-1-2, this classification determines the level of scrutiny the EMC test reports receive from a Notified Body. 

The following classifications have a mandatory requirement for Notified Body approval.

Class IIa: Moderate Risk

These devices often have a physical interaction with the body for less than 30 days or provide non-critical diagnostic data. 

• Examples: Hearing aids, diagnostic ultrasound equipment, dental filling materials, blood pressure monitors, and electronic thermometers.

Class IIb: Moderate to High Risk 

These are often life-supporting or invasive devices used long-term (over 30 days). EMC failure in this class could lead to serious injury. 

• Examples: Lung ventilators, infusion pumps, surgical lasers, intensive care monitors, and X-ray machines. 

Class III: High Risk 

The highest risk category, including devices that sustain life or are permanently implanted. EMC testing for these must be exhaustive as any interference can be fatal. 

• Examples: Implantable pacemakers, prosthetic heart valves, defibrillators, and cochlear implants. 

Medical devices are often highly technical devices and often have connectivity with EMI sensitive systems or sensors. EMC Hire recognises and understands the complexities of these devices and the difficulties of taking a concept design through to compliance.

EMC Hire are here to help! We can support you with EMC design and all pre-compliance EMC testing activities and avoid costly repeat compliance testing.

EMC can support you in a number of ways to suit your needs:

·        Technical support with the generation of test requirements, test planning and technical documentation

·        Test Systems: Bespoke and pre-configured test systems, allowing you to de-risk and perform pre-compliance testing at your premises. Testing can be performed by yourself, or we can support with an on-site EMC Test Engineer who can undertake the testing or train staff to configure and operate the test system themselves. Note, all test systems are supplied with clear and precise instructions on how to configure and use the test system.

·        Development Room: EMC Hire has an EMC Development Room that will allow you access to all the test systems specified by IEC 60601-1-2. Again, an EMC Test Engineer can be present to run all testing, or you have the freedom to run the tests yourselves. Test equipment will already be configured and ready upon your arrival. The Development Room is unique as it can switch between different test methods at very short notice. This allows verification of an EMC fix and have confidence it will work for all different test requirements in a short amount of time.

The On-Site test systems or the Development Room are a perfect solutions for the following scenarios:

·        Development of new devices or sub-systems

·        Pre-compliance testing to gain confidence before undertaking compliance testing

·        Investigate failures and events seen during compliance testing and developing modifications and design changes

·        Validation of design changes against all required test methods

EMC Hire are the perfect partner to assist and support you through the EMC process in the most cost and time efficient way possible!