Even higher quality standards thanks to the Medical Device Regulation (MDR) 

Even higher quality standards thanks to the Medical Device Regulation (MDR)

On the safe side with seca

In Spring 2020 seca was one of the first manufacturers in the medical technology sector to receive MDR certification. In fact, seca is the first company in medical weighing and measuring whose production and quality management has been MDR certified

This means that with seca - as per usual - you are on the safe side, and can use seca products and services in the long term. As far as medical weighing and measuring with seca is concerned, you do not have to worry about anything else regarding the MDR.

What the MDR means

What the MDR means

MDR certification is not easy to obtain and poses challenges to many medical technology companies.  Bottlenecks in the supply of medical technology products can be expected. Due to our early MDR certification, measuring and weighing solutions as well as the medical body composition analysis from seca will continue to be available in the future.

Reliable supply with seca measuring and weighing solutions

The EU is seeking to increase patient safety with the Medical Device Regulation. For us this means that our processes, our hardware and software as well as our services must meet the additional requirements of the MDR. For you this means that the products that you put into operation for the first time must be MDR compliant after the end of the transition period on 31 December 2028.

May 26, 2017
The MDR comes into effect.

May 26, 2020
The MDR becomes valid. Due to COVID 19, the transitional period was extended by another year.

May 26, 2021
No new MDD EU approvals. New approved products must meet the MDR requirements. The MDR EU certificate must be available.

2021 – 2028
Transition periods for putting into circulation and making available on the market and putting into operation.

December 31, 2028
End of the transition period for MDD EU approvals. After the end of the transition period, only MDR compliant products from the manufacturer can be put into circulation.

You can find the MDR certificates here

A Declaration of Conformity (DoC) is issued for every seca product in accordance with the MDR. At seca these are available on the relevant product page under Downloads, or here under Downloads. Since we are currently within the MDR transition period, the MDR certificates will be progressively added until they are all available online by 2023 at the latest.