Medical Devices Regulation – What You Need To Know
Two years ago the new Medical Device Regulations (MDR) were introduced – sweeping legislation designed to ensure that all medical equipment is safe and performs as intended.
The 2017 legislation slipped many people by, but the deadline is looming for when the regulations really take effect and must be fully applied. From May 26 next year, all equipment deemed a “medical device” in the EU will need to undergo a conformity assessment or self-assessment to demonstrate it meets legal requirements. The aim of the new legislation is to improve the quality, safety and reliability of medical devices, while also making information more transparent for consumers. In the wake of various scandals, such as those involving breast implants and metal hip replacements, the definition of “medical devices” has also been significantly expanded in the new Regulations.
Under the new legislation, regulatory authorities will be free to conduct audits at manufacturer’s premises at any time, including unannounced visits. What’s really significant though is that everyone involved in the supply chain will now, have potential responsibility for device defects – that is, any person or company who is placing a product on the market or into service in their own name.
Not all equipment used in a healthcare environment or used by a healthcare professional is a medical device. According to the MHRA, the determining factor for borderline products will be whether or not there is a direct link between the corrective function of the equipment and the individual concerned and that there is a stated medical purpose.
All this means that it’s vital that Occupational Therapists and other health practitioners source equipment from suppliers and manufacturers that are – or will be – MDR-compliant. Ask questions and insist on proof – the all-important CE mark demonstrates that the product has passed the conformity assessment. And don’t assume that Brexit will mean the UK is off the hook: if we do leave the EU, then the MDR regulations and CE marking will be adopted & aligned into UK legislation – the main difference being that we will be considered a 3rd country i.e. outside of the EU27.
At Bakare, many of our products – including our beds – are defined as a “medical device” under the new Regulations. But we’re well ahead of the curve in making sure that these products are fully compliant. It’s not just about certification either – the MDR has also made transparency a priority and we’re covered there too. While many manufacturers are still not even sure whether or not their product would be considered a medical device and are dangerously behind when it comes to becoming compliant, Bakare’s manufacturers, based in Germany & the UK are already carrying out the necessary conformity assessments and have all the processes in place to demonstrate that their medical device meets MDR requirements. The conformity assessment includes an audit of the manufacturer’s quality system and, depending on the type of device, a review of technical documentation regarding safety and performance. Once a product is passed, manufacturers can give it the all-important CE mark.
Back in 2004 as part of a contract to supply Hampshire County Council, Bakare Beds introduced quality management systems that enables tracking & tracing of all products out in the field and issue field safety notices or recalls as required.
To put it another way, at Bakare, you’re in safe hands. This includes all our medical beds, which are considered “low risk” Class 1a products under the new legislation, along with other equipment and accessories. Since the Regulations were introduced, we’ve been working closely with all our trusted suppliers to ensure that all our products meet the requirements and are fully compliant. Don’t let next May take you by surprise! Talk to your suppliers now and find out what they’re doing to ensure they’re MDR-compliant. For further information, do check out the European Medicines Agency overview and MHRA guide.