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Everything you need to know about MDR at Dr. Schumacher
With the entry into force of Regulation (EU) 2017/745 on medical devices (MDR) in May 2017, Dr. Schumacher has been preparing intensively for the new regulations as a manufacturer of medical devices.
Everything you need to know about MDR at Dr. Schumacher
With the entry into force of Regulation (EU) 2017/745 on medical devices (MDR) in May 2017, Dr. Schumacher has been preparing intensively for the new regulations as a manufacturer of medical devices.
Malsfeld – With the entry into force of Regulation (EU) 2017/745 on medical devices (MDR) in May 2017, Dr. Schumacher has been preparing intensively for the new regulations as a manufacturer of medical devices. All necessary measures to implement the comprehensive requirements have been initiated. The MDR replaces the existing Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD). The aim of the MDR is to increase the safety of medical devices, better protect patients, and provide greater transparency and easy traceability of medical devices.
Marketability of the Dr. Schumacher portfolio ensured
From 26 May 2021, Class I medical devices must be MDR compliant. Dr. Schumacher meets this requirement and will place Class I medical devices on the market from 26 May 2021 in accordance with statutory requirements. This regulation applies, for example, to cleaners and care products for instruments.
For medical devices in other classes, including risk classes IIa and IIb, a transition period until 26 May 2024 is provided. Within this statutory period and the term of Dr. Schumacher GmbH's MDD certificate (until 11 June 2023), medical devices in classes IIa and IIb, such as surface and instrument disinfectants, can continue to be marketed as MDD compliant. In parallel, Dr. Schumacher is transitioning medical devices in these classes so that the entire portfolio will meet MDR requirements before the deadline expires.
Comprehensive solutions for infection prevention
The Dr. Schumacher portfolio remains fully available without restrictions. The range offers solutions for all tasks: quality products for cleaning, disinfection and hygiene in both routine use and when requirements are increased. The portfolio therefore offers a broad selection of products for every required spectrum of activity – including short contact times, economical in-use concentrations and very good compatibility.
Supply capability ensured
Reliable supply of medical devices for cleaning, disinfection and hygiene is ensured despite the new MDR transition. Dr. Schumacher demonstrated that it is a reliable supplier during the peak phase of the coronavirus pandemic. In a supplier performance survey, Dr. Schumacher ranked at the top among assessed disinfectant manufacturers together with one other provider.[2]
If you have questions about implementing the MDR at Dr. Schumacher, please contact your Dr. Schumacher specialist advisor or mdr@schumacher-online.com
You can view the full MDR here: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017
Why MDR?
- The EU is responding to scandals involving faulty medical devices with the new MDR and is tightening requirements for medical devices across Europe.
- The new MDR replaces previously applicable national directives such as the MDD and thus helps harmonise rules in the EU.
What are the objectives?
- Increased protection of patient safety
- Greater transparency and traceability of all medical devices
- Better monitoring options and access to documentation
What are the most important changes?
- New classification rules for products
- Increased requirements for clinical evaluation, technical documentation, market surveillance and the vigilance system
- More comprehensive product labelling (e.g. UDI code) and reporting of product data to the European EUDAMED database
What is a UDI code?
- UDI stands for Unique Device Identifier
- The identifier serves the unique identification and traceability of medical devices
- The UDI code consists of two parts: a product-specific identifier (UDI-DI) to identify the product and manufacturer, and a production identifier (UDI-PI) to identify the production unit
- When medical devices must be labelled with the UDI code depends on the respective product class: Class III from 26 May 2021, Class II by 26 May 2022, Class I by 26 May 2025 at the latest
What is EUDAMED?
- EUDAMED stands for the European Database on Medical Devices
- The database is used to manage all important information on medical devices
- EUDAMED improves market surveillance of medical devices and ensures rapid access to all data on medical devices
- The MDR defines which data on medical devices are stored centrally in EUDAMED
- EUDAMED provides greater product transparency for all market participants and the public
Sources:
1. Survey: One year after the MDR postponement – still a lack of clarity, analogue processes and high costs for manufacturers, BVMed - German Medical Technology Association, 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 (accessed on 11 May 2021).
2. Prospitalia GmbH satisfaction survey on supplier performance among 581 acute care hospitals during the COVID-19 pandemic (period: 7 August to 11 September 2020).