The European Medical Device Regulation (MDR) officially took over for MDD on May 26, 2021. Since 2017, ABENA has been working behind the scenes to ensure that all medical devices live up to the newer requirements for transparency and documentation.
Thanks to our years of experience with documentation and sourcing the world, you can trust that our medical products meet relevant MDR legislation and regulations.
Why MDR?
MDR is meant to ensure patient safety, thanks to its 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 the 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 affect 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.
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.
What does it mean to be MDR compliant?
MDR is for your safety. The rules are 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 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 re-evaluating a products function.
- Improved tracking of products: The EUDAMED database, used for tracking products throughout the value chain from manufacturer to end-user, has been updated. It includes stronger requirements for documentation and transparency, including optimized processes for when products are recalled.
Are you looking for MDR documentation on your ABENA products?
Quality assurance
As a part of complying with MDR, ABENA has certified our Quality Management System according to ISO13485.
A strong quality assurance system is an essential part of MDR. ABENA has gone through internal procedures and requirements for documentation and quality assurance to ensure that products meet existing regulations.
ABOUT ISO13485
ISO13485 is an internationally acknowledged standard for quality assurance of medical devices.
ISO13485 has built-in mechanisms that allow for traceability of devices. It has been harmonized to MDR, so by being ISO13485 certified ABENA comply to quality assurance requirements set out by MDR.
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 more than 50 years we have been in the healthcare sector. From working actively with MDD since 1993 to stepping into MDR in 2021 and carrying on with the same high standard that is in compliance with current regulations.
