Country websites:

Medical Device Regulation (MDR)

Regulation (EU) 2017/745

EU MDR requirements

Fresenius Medical Care is committed to ensuring that all our medical devices meet the applicable MDR requirements in accordance with the respective transitional timelines. ​

Questions and answers

  • Fulfillment of MDR requirements
  • MDR transition timelines
  • Timelines for MDR product conformity
  • Expected changes in labeling
  • Product traceability / UDI
  • Relevance of EUDAMED

Does Fresenius Medical Care fulfil the MDR requirements?​

What are the transition timelines from the former Medical Device Directive (MDD) to the MDR applicable for Fresenius Medical Care?​

For the general timelines related to MDR transitional provisions see the illustration. ​

For specific risk classes of medical devices, stricter timelines may apply in accordance with the applicable regulations. ​

However, the MDR timelines are subject to review and possible modification as deemed necessary by the EU Commission. Prominent examples: ​

  • Due to the COVID-19 crisis the MDR date of application has been postponed by the EU Commission by one year to 26 May 2021 (Regulation (EU) 2020/561).​

  • The transitional timeline for certification obligations for specific class I products has been postponed from originally May 2020 to May 2024. Concerned product groups are e.g. medical device software applications being subject to up-classification (Corrigendum to Regulation (EU) 2017/745 from 25 Nov. 2019)​

Transitional timelines of the Medical Device Regulation EU 2017/745
Transitional timelines of the Medical Device Regulation (EU) 2017/745 considering the postponement of MDR date of application as defined by Regulation (EU) 2020/561 Source: Modified infographic from the EU Commission

When will all affected Fresenius Medical Care products conform with the new MDR requirements?​

Which changes in labelling are expected for MDR certified products?​

What extent of product traceability must customers ensure regarding our medical devices after implementation of the UDI labelling requirement? ​

What is the relevance of the EUDAMED database?​

Download of Instructions for Use

For MDR certified Fresenius Medical Care products, instructions for use (IFU) will be provided online, in addition to the printed version. The instructions for use of MDR certified products can be found here.

Background information on the MDR ​

*Factsheets by EU Commission​ for UDI, for Authorized Representatives / Distributors / Importers, and for Healthcare Professionals by EU Commission