Everything you need to know about the MDR at Dr. Schumacher
Malsfeld – The Medical Device Regulation (EU) 2017/745 (MDR) entered into force in May 2017. Dr. Schumacher, as a manufacturer of medical devices, has been hard at work preparing for the new regulations, and all the necessary measures to implement the wide-ranging requirements have been initiated. The MDR replaces the existing Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD). Its aim is to increase the safety of medical devices, to better protect patients, and to provide greater transparency and traceability of medical devices.
Implementing the MDR poses major challenges for many medical device manufacturers. A recent survey shows that 81% of manufacturers consider the MDR to be “very challenging”. In addition to conformity to the new regulations, companies must also assure the availability and range of their portfolio. These demands, together with patient and user safety, are also the focus of attention at Dr. Schumacher. A project team is managing all the necessary measures to implement the increased requirements of the MDR and to transfer all medical devices safely and on time to the MDR.
Marketability of the Dr. Schumacher portfolio guaranteed
The following applies from May 26, 2021. Class I medical devices must be MDR-compliant. Dr. Schumacher fulfills this requirement and will place Class I medical devices on the market from May 26, 2021 in accordance with the legal requirements. For example, cleaning agents and care products for instruments fall under this regulation.
For medical devices in other classes, including risk classes IIa and IIb, there is a transition period until May 26, 2024. Within the framework of this legal deadline and the term of Dr. Schumacher GmbH’s MDD certificate (valid until June 11, 2023), Class IIa and IIb medical devices, such as surface and instrument disinfectants, can continue to be marketed in compliance with the MDD. At the same time, Dr. Schumacher is converting its medical devices in these classes so that the entire portfolio will comply with the requirements of the MDR before the deadline.
Comprehensive solutions for infection prevention
The Dr. Schumacher portfolio remains available in its entirety, without any restrictions. The range offers solutions for all tasks: quality products for cleaning, disinfection and hygiene, both in daily routine and for stricter requirements. The portfolio provides a broad selection of products for every required spectrum of action – short contact times, economical application concentrations and very good compatibility.
The reliable supply of medical devices for cleaning, disinfection and hygiene is guaranteed despite the changeover to the new MDR. Dr Schumacher was already able to prove that it is a very reliable supplier during the peak of the Covid pandemic. In a survey regarding supplier performance, Dr. Schumacher, along with one other supplier, came top of the list of assessed disinfectant manufacturers.
If you have any questions regarding the implementation of MDR at Dr. Schumacher, please contact your Dr. Schumacher technical advisor at mdr(at)schumacher-online.com
You can view the full MDR here: Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017
FAQ on the MDR
- With the new MDR, the EU is reacting to scandals involving defective medical devices by tightening the requirements for medical devices throughout Europe.
- The new MDR replaces previously applicable national directives such as the MDD, and therefore contributes to the harmonization of rules in the EU.
What are the aims?
- Increased protection of patient safety
- Greater transparency and traceability for all medical devices
- Better control and accessibility of the documentation
What are the most important changes?
- New classification rules for medical devices
- Stricter requirements for clinical evaluation, technical documentation, market surveillance and the vigilance system
- More comprehensive labeling of devices (e.g. UDI code) and reporting of device data to the European database EUDAMED
What is a UDI code?
- UDI stands for Unique Device Identifier
- UDI labeling is used for unambiguous identification and traceability of medical devices
- The UDI code consists of two parts: a device-specific identifier (UDI-DI) to identify the medical device and manufacturer, and a production identifier (UDI-PI) to identify the unit of device production.
- The date from which medical devices must be labeled with the UDI code depends on the product class: Class III as early as May 26, 2021, Class II by May 26, 2022, Class I by May 26, 2025 at the latest.
What is EUDAMED?
- EUDAMED stands for European Database for Medical Devices
- The database is used to manage all important information on medical devices
- EUDAMED improves the market surveillance of medical devices and ensures rapid access to all medical device data
- The MDR specifies which data on medical devices are stored centrally in EUDAMED.
- EUDAMED ensures greater product transparency for all market participants and the general public
- Survey: One year after the MDR was postponed – continued lack of clarity, analogue processes and high costs for manufacturers, BVMed - Bundesverband Medizintechnologie e.V., https://www.bvmed.de/de/recht/eu-medizinprodukte-verordnung-mdr/umfrage-ein-jahr-nach-der-mdr-verschiebung-weiterhin-fehlende-klarheit-analoge-prozesse-und-hohe-kosten-fuer-hersteller (retrieved May 11, 2021).
- Satisfaction survey carried out by Prospitalia GmbH to assess supplier performance among 581 acute hospitals during the COVID-19 pandemic (runtime: August 7 to September 11, 2020).