How do manufacturers prepare for MDR?

Recently, the European Union passed the resolution about the extension transition period of MDR until 2027 or 2028. The new deadlines depend on the type and risk class of medical devices.  The implementation of extension is due to many reasons, such as pandemic, long-term review time, much higher requirements of clinical data and evaluation. All of the above reasons cause the medical device with MDD certificate can’t meet MDR requirements on time then going off the market.

What’s MDR?

Medical Device Regulation (MDR) took effect in May 2017 which replace Medical Device Directive (MDD) and Aim Implantable Medical Devices Directive (AIMDD).

What’s the difference between MDD and MDR?

• Mandatory: Regulations have binding legal force throughout every member state and enter into force on a set date in all the member states. Directives require certain results that must be achieved but each member state is free to decide how/when transpose directives into their own national laws.
• Scope: MDR does not only include MDD and AIMDD, but also some non-medical purpose products, such as clean, sterilizing and beauty products.
• Classification has four more classification rules than the MDD. It is based on the potential risks of the medical device.
• Unique Device Identification: or UDI, MDR requires manufacturer add a UDI to medical device and packaging. UDI has two parts which are Device Identifier (DI) and Production Identifier (PI). Manufacturer needs to upload UDI database on EUDAMED, which can link product information or recall.
• European database on Medical Devices: EUDAMED for short. To improve transparency of medical device information. Manufacturers need to regularly update all information in the life cycle of medical devices. Such as SSCP, PMCF, UDI database etc.
• Manufacturer notified body and economic operator's obligations：MDR adds more roles and requirements.
• Sufficient clinical data: In addition to updating technical documents, it needs more clinical data which proves the safety and efficacy of medical devices, like SSCP, PMCF, clinical investigation etc.
• Essential Requirements changed to General Safety and Performance Requirements: ER is changed to GSPR. Basically, the structure of documents has not significantly changed, but the scope and details have increased. Other items newly incorporated in the GSPR requirements, such as risk management and labeling etc.

What manufacturers have to do：

• Confirm the classification of device.
• Collect relevant data about all substances, materials, accessories in production.
• Update Technical document with collect data then provide to NB to submit.
• Provide the device information in life cycle on EUDAMED for reference.

According to TALENT’s experience, we are able to provide you with consultation and solutions for regulation and document preparation.

Contact us for more information.