MDR
New regulations for medical devices (MDR) are in place. The aim of these new regulations is to improve
Why?
To guarantee patient safety, new, stricter European regulations have been introduced to improve the safety of medical devices. These regulations naturally also apply in the Netherlands. The requirements for medical devices to be eligible for market authorization in the European Union have become stricter. This also applies to the requirements imposed on the authorities responsible for market authorization of devices (Notified Bodies) and on manufacturers, importers, and distributors.
Stricter rules will be introduced for the marketing of devices based on products already on the market. Patches, hip replacements, and pacemakers, as well as laboratory and pregnancy tests, all fall under the category of medical devices and in vitro diagnostics. Medical devices make a significant contribution to the quality of life and health of patients. The new regulations therefore create important conditions for a well-functioning internal market for the 25,000 medical device manufacturers in the European Union.
When?
The European legislation and regulations, known as the Medical Device Directory (MDR), has com into effect on May 26, 2021. This will replace the current MDD. This new MDR applies to all medical devices manufactured, marketed, and/or processed within the European Community. From scalpels and syringes to pacemakers, from contact lenses to prostheses, the same European legislation applies to all these devices. The introduction of the MDR was originally scheduled for May 26, 2020, but due to the global COVID-19 pandemic, it has been postponed until May 2021.
What?
The new legislation imposes stricter requirements on the market authorization of medical devices and clearly defines responsibilities for all economic operators. The MDR includes clear rules for manufacturers to monitor the quality, performance, and safety of devices after market authorization. The basic principle is that the manufacturer remains responsible for the quality of its devices throughout the entire product lifecycle. Defects in devices often only become apparent over time. The new rules allow for faster intervention in the event of incidents.
Information about product performance can also be used for product improvements. Manufacturers, authorized representatives, and other market participants will also have other clear responsibilities. Finally, the new rules provide greater clarity about who is liable if a device is defective.
Who?
For the first time, the MDR has also designated the distributor as an economic operator and imposed obligations on their role. These are clearly defined in Article 14 of the MDR, “Obligations of the Distributor,” and can be divided into due diligence, monitoring, and information. Our tip: Be familiar with the regulations in your own industry. Within the MDR’s regulatory framework, Varodem fulfills the role of manufacturer. If you are a supplier of one of the medical devices listed below, you fulfill the role of distributor.
Varodem is a manufacturer of medical devices. All our products are medical devices classified as risk class I, meaning they fall into the lowest risk class according to the MDR. As a manufacturer of low-risk medical devices, we are authorized to determine whether the devices comply with the applicable requirements of the regulation and issue the declaration of conformity in accordance with Annex VIII of EU Regulation 2017/745 on medical devices.
Interplay
The interaction between manufacturer and distributor is defined by a clear set of rules and responsibilities, allowing each to fulfill its own role. For example, when placing a product on the market, the distributor must exercise due care in relation to the applicable provisions of the MDR. This means that the new requirements arising from the MDR, such as the monitoring and information obligations described below, must be taken into account in the context of business activities.
What does Varodem do?
Our medical compression products are CE certified. This is clearly indicated on our product and packaging labels.
Varodem has registered the required EU Declaration of Conformity with the Centre for Certification. This is a necessary requirement for inclusion of our products on the
Declaration of Conformity – Duits / Engels
Declaration of Conformity – Nederlands / Engels
Declaration of Conformity – Frans / Engels
Declaration of Conformity – Duits / Engels (VaroLiner)
Declaration of Conformity – Nederlands / Engels (VaroLiner)
Declaration of Conformity – Frans / Engels (VaroLiner)
All our product labels and packaging labels provide the correct information (MDR-compliant). You will also find the mandatory UDI code (on the packaging labels).