Europe

CE Mark Certification for Medical Devices

A medical device can only be sold in Europe with a CE Mark. By placing the CE mark on a product, the manufacturer declares that their product complies with all applicable European Medical Device Regulations. As a full scope Medical Device Consultancy, we can support CE certification for your Class 1, Class 2a, Class 2b or Class 3 devices.

Medical Device Regulation and IVD Regulation

The final texts of the new European Medical Devices Regulation (MDR) and IVD Regulation (IVDR) have  been published in the Official Journal of the European Union. Entry into force commenced on May 25th 2017, marking the start of the transition period for manufacturers selling medical devices into Europe. The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three years. The IVDR, which replaces the IVD Directive (98/79/EC), has a transition period of five years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.



The Qserve roadmap to EU-MDR Implementation

 

All manufacturers needs to start considering the impact of the EU MDR on their activities, and what they need to do to be compliant with the revised requirements. Implementing the MDR requires a structural approach since the transition to the new MDR CE certificates can last over several years. The Qserve EU-MDR roadmap can be tailored to specific needs of manufacturers.

Qserve Roadmap implementation steps

Scope & Plan: A quick scan of critical impact elements. The plan defines scope, timelines, methods, resources, structures, and tools.Check also the Qserve app.

GAP Assessment: will include device, clinical and QMS related issues, addressing all aspects of the MDR

Portfolio Rationalization: This plan will outline the strategies per device family including cost breakdown.

Global Impact Analysis: The impact on your global registrations can be significantly and the Global Impact Analysis will help as a basis for discussions.

Master Compliance Roadmap: The business organizational structure of the manufacturer and the plan with charters, will be designed.

Regulatory Training: Training ensures that employees are properly aligned with the new regulations. We offer Medical Device Regulation training  

Implementation of Roadmap: The charters have a charter definition sheet with objectives, budget, milestones team members and follow a standardized working method.

Effectiveness Check: The verification of the project charters output is an effectivity check.

EU-MDR Compliance: The final check for compliance with the MDR will be performed by your Notified Body

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