When the European Medical Device Regulation (MDR) goes into effect on May 26th, 2020, you can rest assured continuing use of your regular ABENA products.
The products are the same, but since 2017, we have been working behind the scenes, making sure all medical devices live up to the new requirements for transparency and documentation.
Facts about MDR: Standards and regulations for medical devices
- Since 2017, manufacturers, importers, and distributors of medical devices have been in the so-called ‘transitional phase’, preparing their products to comply with the European Medical Device Regulation (MDR) of 2017 (Regulation (EU) 2017/745)
- "Medical Device" means any instrument, apparatus, appliance, software, implant, reagent, materials or other articles intended by the manufacturer to be used, alone or in combination, for medical purposes for human beings (from article 2 in MDR). This includes incontinence products, bed protection, wound care and gloves.
Why MDR?
MDR is meant to ensure patient safety thanks to the high standards for transparency, documentation, tracking, and feedback loops. Regulating medical devices is nothing new. Since 1993, MDD (the Medical Device Directive) has been the governing body for safety and efficacy of medical devices in Europe.
With more than 500,000 types of medical devices on the EU market, safety regulations for medical devices affects millions of users all over Europe. With the onset of MDR, European legislation and medical devices now live up to the latest advances in science, technology, and product safety.
What does it mean to be MDR compliant?
MDR is for your safety. The rules have been strengthened and reevaluated to protect the users of medical devices through increased transparency throughout the value chain.
A few of the most important changes that will ensure transparency and patient safety include:
- Increased documentation: To make sure products are safe to use, documentation and risk analysis plays an increased role in MDR.
- Stronger feedback loops: The increased focus on documentation also requires manufacturers to actively listen and react to consumer and customer feedback. Processes must be in place to actively take feedback and complaints into account when reevaluating a products function.
- Improved tracking of products: The EUDAMED database, used for tracking products throughout the value chain from manufacturer to end-user, is being updated. It will include stronger requirements for documentation and transparency, including optimized processes for when products are recalled.
Important to know regarding existing stock:
- Medical Class 1 devices (compliant with MDD) produced UNTIL and INCLUDING the 25th of May, 2020, may still be distributed and sold. The production date is the essential element.
- See the official statement from Abena here.
You don't have to know everything about MDR - because we do
Because we care, patient safety has been an integrated part of ABENA’s culture in the nearly 50 years we have been in the health care sector. From working actively with MDD since 1993, we have the experience to confidently say we are ready for MDR to step into full effect on May 26, 2020.
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