The Medical Device Regulation (MDR), or EU 2019/745, becomes law throughout the European Union on 26 May 2021 and Safe Care Technologies has made the appropriate preparations.
This page explains the background to the new standard and what it means for us as a provider of AT, and to you, our customer.
The MDR is an updated and expanded version of the earlier Medical Device Directive (MDD) and the most significant change for the assistive technology industry is contained in the definition, which now includes the clause…
Medical Devices means any instrument, apparatus, appliance, software…. or other article intended to be used for the diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability.
This means that our industry is now ‘in scope’ for the first time and our need to comply is unequivocal.
Safe Care Technologies embraces the improved standards and subscribes to the view that compliance will improve the whole industry through increased quality, reliability and traceability of all assistive devices offered both by us and other AT vendors.
What does this mean for the devices we sell?
The MDR is built around several core tenets:
A rigid Quality Management System
Registration of all products on an EU-wide product database
Full traceability through a worldwide standardised marking system
On-going Clinical Evaluation of all devices
On-going Post Market Surveillance and Risk Management
Safe Care Technologies has been investigating all the appropriate MDR preparations to ensure the devices we sell conform to these regulations. We keep on file the Declarations of Conformity of all products we sell.
All the products we sell are registered with the Health Products Regulatory Authority (HPRA).
The representative in Ireland is:
European Healthcare & Device Solutions Ltd
Republic of Ireland.
Attention Paul Rowden
What does it mean for our end users?
If you are an end-user, these changes won’t affect you directly. You will see some small changes to the product labelling and instructions, but otherwise, the products remain the same.
The other big difference is that you will start to see new product markings on all our products. This takes the form of a Data Matrix (similar to a QR code in appearance) and a series of numbers alongside it. A typical numbering scheme looks like this:
The number beginning (01) is the UDI-DI and is an internationally recognised unique number for each product type. When you receive the Declarations of Conformity you will be able to look up each of these numbers from the certificates. These have been registered with HPRA through our EU Representative and will be registered with EUDAMED once it comes into being.
The number beginning (11) is the manufacturing date and is in yymmdd format. This will help you with determining which products are in warranty and differs from our previous wwyy format.
The number beginning (21) is our usual serial number and is unique for every product shipped. It is always seven characters long and begins with a letter. The date code and serial number make up the UDI-PI. In any correspondence about a particular product, please quote all three numbers where possible.
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