MDR Information
Bellman & Symfon is in compliance with the essential requirements of the Medical Device Regulation EU 2017/745
In 2017, The European Medical Device Regulation, ´MDR´, came into force, replacing the Medical Device Directive, ´MDD´. Bellman & Symfon is well prepared for the MDR transition. The internal MDR transition program has been in place since 2019, working to secure compliance with the MDR obligations. Class I medical devices must be MDR certified by May 26, 2021, the MDR date of application to remain on the market.
Bellman & Symfon MDD-certificated medical device class I, that have lawfully been placed on the European market before the MDR date of application 26 May 2021, will continue to be made available on the market up until latest the 27 May 2025.
Timeline:
2019
Bellman & Symfon initiate the MDR compliance program.
2020
Updating QMS procedure, MDR training and updates of technical and clinical documentation. Registered at Bellman & Symfon Group AB, as MDR manufacturer at Läkemedelsverket.
2021
May 26, MDR date of application for Class I medical devices transitioned to MDR. Assigning basic UDI.
2022
Bellman & Symfon Group AB will be registered in Eudamed as manufacturer and list all Medical Device products.
2025
MDD class 1 devices already placed on the market before MDR date of application, May 26th 2021, can continue to be made available until May 27th 2025.
Medical Device Information
Updated IFU’s (Instruction for use) is found per respective product under resources on our product pages. DoC’s (Declaration of conformity) is listed below per product assortment family.
Our offer
We develop innovative and high-quality solutions within audio and alerting that empower people to stay safe, independent, and socially active.
Our Medical devices are designed, manufactured, distributed, and tracked according to MDR requirements and develop according to MDR-compliant regulatory systems, processes, and documents for the safety and performance of our products.
What does the MDR regulation mean?
The main three objectives for the new regulation:
1 Improve the health and safety level
2 Continue to enhance the free trade of medical devices in the EU
3 Ensure products are current to state of the art technology and scientific knowledge
We do this because we care!
Customer Centric
We take the complete customer experience into consideration and go beyond the features of a physical product.
Quality driven
We strive to continuously improve the way of working to maximize customer satisfaction and minimize waste of resources.
Solution oriented
We don’t sell products. We are providing solutions to our customers’ problems. Our products and services are the tools.
