In Europe, all medical device companies (both legal manufacturers and distributors) who wish to market or sell their products in the European Economic Area (EEA) marketplace now have to comply with the European Medical Device Regulation (MDR). This is a new set of regulations that govern the production and distribution of medical devices in Europe.
3 of Nipro’s legal manufacturers for medical devices in Europe – Nipro Pure Water (NPW) in Germany, Nipro Renal Solutions (NRS) in Spain, and MTN Neubrandenburg in Germany – successfully completed their audits in 2022-23, and have received the MDR certification, allowing them to continue supplying the European market with Nipro’s extensive portfolio of value-added medical devices.
In 2018, Nipro initiated the project to gain MDR certification and worked on it over the next 4-5 years, performing a gap analysis of the new regulations and Nipro’s position then. A project plan was developed including new testing according to the new regulatory requirements and the establishment of new procedures. A conformity assessment of Nipro’s products with the notified body also took place.
Nipro’s RA/QA Manager (NME Plants), Ivan Canal, shares how teamwork across the 3 legal manufacturers was essential for Nipro’s success:
The European Medical Device Regulation (MDR) has proven a major challenge for the medical devices industry in Europe. In order to continue placing medical devices on the market in Europe under the new legal framework, medical device companies have had to make a significant effort to update their Quality Management System (QMS) and upgrade their Technical Documentation (TD). Furthermore, companies needed to interpret new and tightened rules prior to the audit without any guidance from the notified body.
The MDR certificate was awarded to each of Nipro’s legal manufacturers for medical devices in Europe separately: NRS was awarded in March 2022; MTN was awarded in August 2023; and NPW was awarded in September 2023. The MDR certificates are valid for 5 years and will be renewed following another audit.
