Cranage EMC &
Safety offers one of the most comprehensive testing and evaluation services for
both highly sophisticated medical equipment and manual and electrical equipment,
from ECG monitors, mass spectrometers, baby breathing monitors through to
patient trolleys, hoists, ventilators, wheelchairs and autoclaves.
Medical Device EMC Testing - What are the regulations?
Within the EU, the Medical Devices Directive 93/42/EEC (MDD) details the essential requirements that manufacturers must meet in order to gain a CE marking and sell their device within Europe. However, the Medical Device Regulation 2017/745 (MDR) will replace the MDD, as well as the Active Implantable Medical Devices 90/385/EEC (AIMD), and manufacturers have until 26th May 2021 to comply with the MDR. Within the MDD, medical devices are categorised into 4, based on their risk. These are:
• Class I - considered to be the lowest risk.
• Class IIa - usually low to medium risk and not used for long periods of time, for example tracheotomy tubes.
• Class IIb - medium to high risk and may be used for longer than 30 days, such as ventilators.
• Class III - these are the highest risk, an example being pacemakers.
There have been some changes to classifications within the new MDR, and therefore changes to the process of assessing conformity. It is imperative that manufacturers review these and classify their products appropriately.
Most manufacturers of Class I devices (unless sterile or those with a measurement function) may self-declare their product confirms with the MDR. Class IIa, Class IIb and Class III must have the involvement of a Medical Notified Body to approve their Declaration of Conformity (DOC). Cranage EMC and Safety has a vast range of testing experience in the medical field, and our test results form part of the assessment by the appropriate Notified Body. All manufacturers must produce a Technical File to show compliance and the level of detail required has changed in the new MDR.
How much does CE Marking for Medical Devices cost?
Testing is product specific, due to the range of medical devices and therefore the cost of testing varies. We are UKAS accredited for the standards IEC/EN 60601-1 and IEC/EN 60601-1-2, showing we have been assessed as technically competent for these standards. Get in touch with our team to discuss the cost of testing your medical device
How do I get my medical device CE marked?
CE marking is the responsibility of the manufacturer and is used to confirm the medical device meets the essential requirements of the MDD. A CE mark cannot be applied on Class IIa, Class IIb or Class III devices until a certificate has been issued by a Notified Body.
Manufacturers must also register their device with the relevant Competent Authority, which is the Medicine and Healthcare products Regulatory Agency (MHRA) in the UK.
What standards do I need to my medical device to be tested for?
Medical devices must be tested for the relevant product safety and EMC standards to ensure they are safe to use. The most common standards are IEC/EN 60601-1 and IEC/EN 60601-1-2, covering the basic safety and essential performance of medical electrical equipment. Cranage EMC and Safety is a UKAS accredited test laboratory for these standards and our team of experienced engineers can test a vast range of medical devices, with our previous tests including hospital beds, prosthetic limbs, blood pressure monitors, ultrasound devices and pulse oximetry.
Using state of the art equipment to test your medical equipment Cranage EMC & Safety is here to ensure all of your testing and evaluation needs are met in full.
IEC 60601 testing
Our engineers also have a vast experience in testing and evaluating equipment for compensation or alleviation of injury, disease or disability.
Cranage has core competency in all areas of MDD and IVD and constantly strives to provide absolute testing certainty, accurately and reliably, so whether your needs are for testing blood sampling equipment, gas pressure monitoring equipment or a simple weighing machine we offer a service you can trust.
Medical Products and Equipment include but not limited to:
|• Medical Electrical Simulator for IVF
• Blood Sampling Equipment
• Gas Pressure Monitoring Equipment
• Baby Breathing Monitors
• Mass Spectrometers
• Wheelchairs and Stair Lifts
• Weighing Machines
|• Cardio Respiratory
• ECG Monitors
• Hospital Beds
• Patient Trolleys
• Syringe Pumps
Get in touch with our team to discuss how we can help you with your medical device testing.
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
|Monday||- 09:00 to 17:00|
|Tuesday||- 09:00 to 17:00|
|Wednesday||- 09:00 to 17:00|
|Thursday||- 09:00 to 17:00|
|Friday||- 09:00 to 17:00|
Marketing and Sales
Tel: 01630 658568
Rated 5 out of 1 reviews
Leave a review!
We have always found Cranage to be professional and flexible, willing to respond at short notice to changing scenarios and able to provide positive contributions when developing compliant solutions.