What are the regulations for medical devices?
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 mark 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 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 MDR. 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.
The Government have recently published guidelines on the new UKCA mark, that will be used to replace the CE mark from January 2021. However, CE marking will continue to be recognised in Great Britain for medical devices until 30th June 2023.
What standards do I need 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.
How much does testing of medical devices cost?
As each product varies, we provide quotes based on your specific project details.
Get in touch with our team to discuss how we can help you with your medical device testing.
