Medical Device Regulation (MDR)

The Medical Device Regulation (MDR), or EU 2019/745, becomes law throughout the European Union on 26 May 2021 and Pretorian Technologies is ready. This page explains the background to the new standard and what it means for us as a provider of AT and you as our customer.

Background

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.

Pretorian 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 are the requirements on us as a manufacturer?

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

Pretorian has been investing in MDR preparations for more than 18 months in readiness for the May 26th deadline and now has all the necessary systems and documentation in place. All 1100 pages of it!

Because the UK is unfortunately no longer an EU member state, Pretorian is required to nominate a Representative within the EU and we have appointed the following Regulatory Affairs company to take on this role:


European Healthcare & Device Solutions Ltd
Stratton House,
Bishopstown Road.
Cork.
Republic of Ireland.

Attention Paul Rowden

They have registered our products with the Health Products Regulatory Authority (HPRA) in the Republic of Ireland.


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 are the same as they have always been.


What does it mean for our EU distributors and resellers?

If you are a distributor or reseller in the European Union, there are a number of things that will be different. First of all, you need to keep on file our Declarations of Conformity for all the products you carry. Please click on the button below and fill in the form and we’ll send them to you.





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:


Example Data Matrix MDR
Example Data Matrix

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.

Although the MDR burden falls mainly on us as the manufacturer, you as a distributor or reseller also have responsibilities and these are mainly described in Article 14 of the MDR. Please make sure you have read this thoroughly and refer any questions to us.

As part of our responsibility to conduct on-going Post Market Surveillance, we will also contact you at least annually to request market information by way of a questionnaire. We ask that you please complete this and return it to us in a timely manner.