GroupMedical Device Regulation
Wassenburg Medical B.V. leads the way as one of the very first manufacturers of Endoscope washer-disinfectors to be certified under MDR (2017/745)
Wassenburg Medical B.V., a leading developer and manufacturer of Automated Endoscope Reprocessors (AER), is happy to announce it has received the Medical Device Regulation (MDR) certification from its Notified Body, the British Standards Institution (BSI), ensuring continuous market access of their equipment in the European Union (EU). The certification has been received for all AER models in the company´s portfolio.
Wassenburg Medical was granted the EU Quality Management System (QMS) Certificate confirming that the Company’s QMS and its equipment is compliant with the latest regulatory standards required for medical devices in Europe.
Alexander Vermeulen, Director Compliance at Wassenburg Medical, commented: “Achieving the MDR certification is another major milestone and the result of our early adaption to the new and more stringent regulatory requirements in Europe. This achievement would not have been possible without the extensive and diligent work of the entire Wassenburg Medical team.”
Ronald Wassenburg, President at Wassenburg Medical, also added: “Without doubt, MDR has raised the standards for medical device regulation and we are excited to be one of the very first Endoscope washer-disinfector manufacturers to receive this certification. It shows our strong commitment to complying with the highest regulatory standards for medical devices. Our early certification also offers assurance that Wassenburg Medical is committed and ready to be the long-term partner of choice to our customers.”
About European Medical Device Regulation (MDR)
The MDR (Regulation (EU) 2017/745) replaces the former European Medical Device Directive (93/42/EEC), and includes more stringent standards and requirements in both clinical and post-market areas. The new Regulation is intended to create a robust, transparent, sustainable and international recognized regulatory framework for improved clinical safety and fair market access for manufacturers. The MDR ensures alignment among European member states, and is applicable for the entire lifecycle of the products and the processes supporting the solution delivery.
It represents the biggest change in European medical device compliance standards for more than 20 years.
For every patient a safe endoscope: for now and in the future.
About Wassenburg Medical
Wassenburg Medical B.V., originally a family company, was established in 1984 by Gerrit Wassenburg and has developed into a highly regarded specialist in all aspects of automated endoscope reprocessing. The Vision of Wassenburg Medical is to provide a safe endoscope for every patient, while the ultimate goal is infection-free patient treatment and a safe, user friendly, efficient, and innovative endoscope reprocessing process at every hospital or clinic.
At Wassenburg, we are passionate about designing and delivering safe and innovative products and services. We want to raise the bar and the standards within the international endoscope reprocessing industry.
Wassenburg Medical is part of the HOYA corporation and is headquartered in Dodewaard, the Netherlands.
Dodewaard, the Netherlands – December 2023