The EU MDR is the European Union Medical Device Regulation, with intent to ensure a high standard of safety and quality for medical devices that are produced in, or supplied to, the European Union. After an extensive audit and closing of all technical assessor questions Evercare Medical are pleased to state that the company now has all MDR certificates in place. This means that we are able to continue to offer safe, trustworthy and reliable medical supply products also after 2024, in compliance with our MDR quality control.
Our internal transition journey from Directive 93/42/EEC MDD towards Regulation 2017/745 MDR started in 2018 with a GAP analysis followed by hard work towards compliance with the MDR-obligations.
All documentation for Evercare Medical’s products is now updated based on one of the most efficient yet compliant quality management systems for medical devices and personal protective equipment on the market. This also means that we can now launch new products and improve existing towards a sustainable future together.
Seven assessors spent about 500 hours to review our MDR quality system and the details in our technical documentation for Class I sterile and Class IIa products. In all cases Evercare Medical showed to have good control and procedures, documentation, and traceability in place.
In parallel with the work towards MDR certification Evercare Medical managed to maintain high level of quality for all products during the pandemic, with higher demand, difficulties to source high quality materials and logistic challenges.
The quality management systems (CMS) audit was made by the Notified Body MDR in January 2022.
