Regulatory affairs

New Medical Device Regulation for medical devices

Nearly everything will change
Are you "MDR-ready"? We certainly are, and we will help you to make your medical devices MDR-compatible.
The Medical Device Regulation (MDR 2017/745) changes the requirements for manufacturers selling medical devices within the EU. The new directive aims to increase the levels of quality and traceability of medical products. It impacts the processes involved in manufacturing your products and will mean more testing and more documentation.

Adaptation of QM system and technical documentation
Manufacturers of medical devices must adapt their QM system to the new MDR and provide a considerable amount of new information.
Moreover, the requirements have increased regarding product documentation, which will become far more comprehensive and will also need to include documentation from the suppliers of components used.
This refers to all manufacturers who market medical products within the EU.

Fast track to an MDR-compatible user interface

The MDR-compatible documentation must also include the user interface. The supplier must provide, amongst other things, product specifications, process information, risk analyses and certificates. This proves that the development, production and quality control of these components all meet the MDR requirements.
If you buy hand and/or foot controls from steute, we can optionally provide you with comprehensive product documentation which you can then include in your complete device documentation. This will make the approval process for your overall system – including the user interface – considerably simpler.

With steute Meditec you will be "MDR-ready" on time
With us as a partner by your side, you can present the manufacturing process of your user interface in a manner which is both clear and in accordance with the MDR. The approval for your overall system is then quicker and easier – and you are "MDR-ready" sooner.

Simplified approval also for the US-American market

We support your device approvals not only in Europe, but also for the US-American market. We at steute Meditec are FDA-registered within the FDA Establishment Registration (21 CFR 807) framework as a "Contract Manufacturer". We can therefore optionally provide you with FDA-compatible documentation and manufacturing of your user interface.
This has the following advantage for your device approval in the USA: we are already known to the FDA as a listed supplier and manufacturer. If you apply for approval for a medical system which is fitted with a steute Meditec user interface, we can optionally register as a "Contract Manufacturer" with the FDA Device Listing for your medical system. In this way we can work together to prove that your components and accessories are also manufactured at an FDA-registered production site.

"All inclusive"

Our QM documentation is comprehensive. Depending on the customer wishes and technologies used, it includes:

Process information

  • Process flowchart
  • Final inspection plan
  • Inspection sheet for final inspection

Risk analysis

  • Risk management (DIN EN ISO 14971)
  • Design FMEA
  • Process FMEA

Certificates & annotations

  • Certificate EN ISO 13485:2016
  • Certificate IEC 60601 issued by the CSA
  • Software validation (EN IEC 62304)

As an optional extra we can provide a CB certificate to IEC 60601, issued by the CSA and complying with the "CB scheme" established for electromedicine and accepted by international approval bodies.