The Regulation on Medical Devices (MDR) and the Regulation on in-vitro Diagnostic Medical Devices (IVDR) went into effect in May of 2017, effectively replacing decades-old legislation and creating new quality and transparency requirements for medical device companies in the European Union.
The Official Journal of the European Union published the MDR and IVDR. The new rules replace Med Device Directive (93/42/EEC), the Active Implantable Medical Device Directive (90/385/EEC) and the In-Vitro Diagnostic Medical Device Directive (98/79/EC).
Although the MDR and IVDR are both technically “in effect,” there will be a transitional period of up to five years for companies to fully comply with the directives.
The new regulations outline stricter quality requirements as well as enhanced transparency for medical devices manufactured or imported to the EU. The new regulations represent an opportunity for medical device manufacturers and sellers to tap into a million-dollar market while also increasing the chances of positive patient outcomes.
Below we’ll look at some of the most salient changes put forth by the MDR and IVDR.
Quality System Updates
The MDR outlines new quality and risk management obligations for medical device companies. Specifically, the new regulation lays out more specific guidelines for the production and quality procedures associated with devices.
The MDR requires that a company create a documented risk management plan for medical devices that identifies possible risks associated with the device’s use, and thoroughly evaluates the information gained from a device’s production phase to identify possible hazards.
On top of updates to quality and risk management systems, medical device manufacturers must also create a post-market surveillance plan. These regulations will be checked randomly by inspectors.
Classification Changes for Medical Devices
The MDR brings slight changes to the classification of medical devices. Medical devices are currently classified as either Class I, Class IIa, Class IIb, or Class III. The higher the class level, the higher the risk.
MDR will move certain devices that come into contact with the spinal cord into Class III. In addition, certain changes have been made to some apps for medical devices used on smartphones.
As a result of these changes, medical device manufacturers will need to make sure they are compliant with the new classification rules.
Eudamed Database
In an attempt to make medical device information more accessible, MDR will make certain information regarding medical devices accessible to the public through the European Database on Medical Devices, or “Eudamed.”
The Eudamed database will include information on devices’ market surveillance, clinical investigation information, and safety and clinical performance.
Medical devices in the EU will also be tracked online with a Unique Device Identification (UDI) number, making it easier to glean information on individual products. These UDI numbers will be located in Eudamed.
Increasing Safety and Transparency with the MDR and IVDR
The goal of these new regulations is to improve safety, quality and transparency for medical devices across the EU. Regulations for both the MDR and the IVDR will not become applicable right away. There is a transition period of three years for the MDR and five years for the IVDR.
All medical device manufacturers and distributors will have to abide by the new regulations. No company will be “grandfathered” in.
You can view the MDR here. The full text of the IVDR can be found here.
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