Arion brands are compliant with the Medical Device Regulation 2021!
The Medical Device Regulation (MDR) is the latest EU legislation detailing manufacturers’ requirements to sell medical devices on the European Union market.
MDR (EU 2017/745) replaces the former Medical Device Directive (MDD, 93/42/EEC) implemented in the ’90s.
Why did the EU decide to change the legislation about medical devices?
The change was linked to divergent interpretations of the current Directives and incidents concerning product performance, highlighting certain legal system weaknesses.
Besides that, the EU institutions revised the laws governing medical devices and in-vitro diagnostics to align with the sector’s developments over the last 20 years.
The revision aimed to guarantee a robust, transparent, and sustainable regulatory framework and maintain a high level of safety while supporting innovation. As a result, in May 2017, two new regulations on medical devices entered into force.
The plan was to progressively replace the existing directives through a transition period of three years until May 2020. Due to the covid crisis, the EU decided to postpone the transition (EU2020/561) until the 26th of May 2021.
What are the main differences between MDD and MDR?
MDR is a regulation adopted in the same exact format for all EU member states. MDD (MDD, 93/42/EEC) was a European Directive that members states had to translate and implement in their national law.
Additionally, the Medical Device Regulation prioritizes the life-cycle approach to the medical device and focuses less on the pre-approval phase of medical device manufacturing.
What changes did the MDR bring?
• improved transparency through a comprehensive EU database and a device traceability system based on a unique device identification (UDI);
• reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorising multi-center clinical investigations;
• strengthened post-market surveillance requirements for manufacturers; Backing up marketing claims by actual data is mandatory for medical devices.
• improved coordination mechanisms between EU countries;
• product scope expansion: definition of a medical device or an active implantable medical device is significantly expanded to include devices with no medical intended purpose.
• identification of “qualified person” – manufacturers have to identify one person within their organization formally responsible for all aspects of compliance with the new regulation requirements.
How can a customer know if a product complies with the MDR?
A product that complies with the MDR has a CE and an MD mark on its package. The marks indicate the manufacturer has signed a Declaration of Conformity specifying the product’s intended purpose as a Medical Device.
Under the MDR, all previously approved medical devices must follow the new requirements to keep the CE mark. Medical Devices manufacturers can still place medical devices compliant with MDD instead of MDR if the products have a production date before the 26th of May 2021.
Arion and the new Medical Device Regulation
Arion has chosen to have most of its Swash® and Arion Slide Solutions products notified as Medical Devices due to the higher standards adopted in the manufacturing process. Medical Device compliance offers extended guarantees to the users of Arion Slide Solutions and Swash®. For instance, the requirements for quality assurance in production are much higher for Medical Devices than for Cosmetics. Moreover, the Good Manufacturing Practice principles under ISO 13485 (medical devices) go further than under ISO 22716 (cosmetics).
As a Medical Devices manufacturer, we must endorse every claim (whether for application or safety) with actual data. Hence, we must continuously monitor that no problems occur with the product (e.g., allergic reactions). Furthermore, we must conduct continuous risk-benefit analysis to demonstrate that the product is safe and that the benefits outweigh the risks associated with the product.
If problems do occur, the manufacturer must:
– demonstrate that these reactions were unforeseen and could not have been prevented;
– document the complaint (risks): the company has to take corrective and preventive actions;
– demonstrate planned measures for system improvements;
– update the risk assessment report regarding the product;
– continuous improvements in product quality, safety and efficacy.
As manufacturers of medical device class I, Arion has a transition period to implement UDI until 2025, when the UDI becomes mandatory.
MDR provides the right framework for a more uniform and equal standard in the European Medical Devices market. The improvements brought by the new regulation contribute to better quality in healthcare for patients and medical device users.