What is the MDR?
On the 26th of May the new Medical Device Regulation (MDR) comes into force.
This is a replacement for the old Medical Device Directive (MDD) and governs the production and distribution of medical devices in Europe. While originally something the UK was part of as part of the EU, the UK have now signed up to meet those regulations alongside the EU to provide standardised processes and standards for manufacturers and distributors.
Here at Harvest we are proud to say all our medical devices are in line with the MDR, and we will continue to supply all our products without any break in supply.
What Changes is the MDR Making for Customers?
Our customers are unlikely to notice any changes in the products, beyond some simple changes in the labelling such as the addition of more barcodes.
With all our products up to scratch, we won’t have any break in trading for our medical devices, and our suppliers for the products we don’t make in house are all also certified.
We always love feedback on our products, but this is becoming more front and centre with the new MDR. What you may find is that we ask you for more feedback, and we would be really grateful for your support as always.
What Changes is the MDR Making for Suppliers?
The new MDR is a lot more comprehensive than the old MDD. Where the old MDD had 23 articles, the MDR has a hefty 123, and comes in at nearly three times as many pages! While nothing from the old MDD has been lost, a lot has been added in, including:
• A unique device identification system
• Changes in the classes of some major product groups
• More stringent requirements for clinical evaluations and investigations
• Upgraded requirements for post-market surveillance.
We have been working hard to be ready and waiting for the MDR and are thrilled we can say we have full compliance. Naturally, an increase in regulation leads to improvements for everyone in the supply chain, and we are really excited to be part of this new chapter for medical devices.
Did You Know?
We are dedicated to the best regulatory compliance at Harvest, but also help our customers meet their regulatory needs too!
Side rail height regulations are an area we regularly support our customers with. Put in place by the government and checked by the Care Quality Commission (CQC) in order to prevent entrapment, these regulations can be a minefield for organisations with lots of bed and mattress combinations. Thankfully, any Harvest mattress is compliant when on any Harvest Woburn bed – how’s that for peace of mind?
Have a look at our comprehensive guide to bed rail regulations more information on how we can help you >> Bed Rail Regulations: Your Guide
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