WHAT IS THE MEDICAL DEVICES REGULATION?
The Medical Device Regulation (MDR) is a new regulation in the EU that came into force on 26 May 2021. It helps make medical devices even safer and more reliable by enforcing stricter requirements. The MDR replaces the old directive and introduces stricter safety and performance requirements. This means that all products, including those already on the market, need to be retested and re-evaluated. The same goes for washer-disinfectors from MEIKO – for professional infection control solutions in medical settings. New medical devices may only be placed on the EU market if they have MDR certification.
WHY IS THAT IMPORTANT?
MEIKO viewed the transition to the new MDR as a rapid process. It demonstrates the company's ability to adapt swiftly to new regulations while continuing to deliver top quality, safe products without incurring long waits for customers.
‘MEIKO has demonstrated yet again that MEIKO customers can rely on us. Every customer who purchases a washer-disinfector from MEIKO can be confident that it meets all legal, hygiene and technical requirements – both now and in the future.’
Martin Schömezler, Head of Professional Business Unit MEIKO Care
WHAT DOES THIS MEAN FOR CUSTOMERS AND PARTNERS?
For customers and partners of MEIKO, the MDR certification* means one thing above all else: Confidence. You can be confident the products confirm to the latest standards and deliver the highest quality. As Ingo Wiegand, Head of Product Compliance Management at MEIKO, explains: ‘Being among the first in our field to receive MDR certification demonstrates our ability to quickly adapt to new regulations and continue to bring safe, high-quality, safe MEIKO products to market without delay.’
MEIKO continues to lead the way in the medical device industry with its washer-disinfectors. Being awarded MDR certification at an early stage highlights the company's commitment to quality, safety and compliance.
The successful transition to MDR certification is a significant milestone for us in gaining approval for our washer-disinfectors in the EU and bringing them to that market. It also highlights our commitment to the safety and reliable availability of our products.
Dr.-Ing. Thomas Peukert, CEO of the MEIKO Group
HOW DO MEIKO CUSTOMERS BENEFIT?
There have been no technical modifications to MEIKO washer-disinfectors. That said, the MDR certification process did involve more rigorous tests, which they passed with flying colours. Hospitals and care facilities benefit from this directly and indirectly in a number of ways:
- Enhanced hygiene safety: The more stringent safety and performance requirements of the MDR ensure that our washer-disinfectors, and the reprocessed urine bottles and care utensils, are even safer and more reliable. This can help to reduce the risk of infection and minimise nosocomial infections.
- Confidence in product quality: The MDR certification confirms that our products comply with the statutory requirements of the Medical Device Regulation (MDR), which is essential to distribution in the EU. This gives care facilities the assurance that the appliances they are using are safe and effective.
- Efficient hygiene management process: Certified washer-disinfectors mean that hospitals and care homes can organise their cleaning, disinfection and reprocessing of bedpans and care utensils more efficiently. This contributes to a seamless bedpan management process.
- Compliance with statutory regulations: MDR certification* signifies that the products meet the latest regulatory requirements, which is essential to compliance with healthcare and hospital hygiene regulations.
SUMMARY
MEIKO is your trusted partner when it comes to providing top-quality, safe medical devices like the washer-disinfectors from MEIKO.The successful transition to MDR certification* further demonstrates our ongoing commitment to compliance and adaptation to statutory requirements, ensuring the highest quality and safety of our medical devices. And users reap the benefits every day – across hospitals, care facilities and the healthcare sector as a whole.
* MDR certification does not imply any warranty or liability claims going beyond the statutory regulations. For more information on our warranty and liability terms, please get in touch with our customer service team.
