Several devices not covered by the previous Medical Device Directive (MDD) requirements now fall under the MDR requirements, and in many cases, the devices need to be re-classified.
MDR will replace the existing Medical Device Directive (92/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD).
The main reason for MDR is to ensure high standards of quality and safety for medical devices being produced in or supplied into Europe.
The regulation holds amongst other several new requirements that must be adhered to:
- Even for Class I devices, an ISO 13485:2016 compliant Quality Management System (QMS) is now required.
- New Medical Device Classifications and system supported by the Conformity Assessment
- Registration and communication related to the Authorized Notified Body with an agreed mandate
- Registration in the European database on medical devices (EUDAMED)
Labelling (CE) and UDI (Unique Device Identification) documentation and maintenance.
- Post-Market activities, such as implementing a surveillance system and a system for reporting incidents and safety corrective actions.
Reliant can offer a scalable turn-key solution and services that will support and enable startups, spinoffs, small and medium-sized medical device companies to comply with the new regulations listed above. We are ready to support the new quality and regulatory requirements that must be met throughout the medical device lifecycle.
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How to determine if one of the standards under your quality management system is recognized under the European Medical Device Regulation or EU MDR.
The timeline can be a bit confusing. Here are a few pointers on how to find the registration date for your products.
for EU MDR
The deadline to transition to the EU MDR is May 26, 2024.
Are you looking for information on how to start the transition
or how to best structure your organization?
Reliant Life Sciences has partnered with MDR Consultants
and Isabel Osorio to offer hands-on training.
To learn more and to sign up, please visit their website.