EU Medical Device Regulation(MDR) Registration

In today's global medical device market, the EU is one of the most important markets, and its regulatory compliance is crucial for manufacturers. The implementation of the EU Medical Device Regulation (MDR) 2017/745 not only improves the safety, effectiveness, and performance of medical devices, but also puts forward stricter requirements for manufacturers.

About Us

As a professional medical device regulatory compliance service provider, Proregulations has deep regulatory knowledge and rich practical experience. We provide a full range of EU MDR registration services, specializing in ensuring that your products comply with the latest regulatory requirements, quickly and efficiently obtain the CE mark, and legally enter the EU common market.

Our Services

Guidance on the Classification of Medical Devices

According to the MDR, medical devices are divided into four categories, and each category of device needs to meet different evaluation pathways and technical requirements. We help customers accurately define product categories and avoid registration delays caused by misclassification.

• Class I

Low-risk devices, including sterile conditions, measuring functions, and reusable surgical instruments. Although the device's risk is low, it still needs to meet certain technical requirements.

• Class IIa

Intermediate-risk devices such as catheters, hearing AIDS, and short-term contact lenses. Manufacturers of such devices are required to obtain a declaration of conformity from a designated body following a conformity assessment.

• Class IIb

Medium-high risk devices, such as incubators, insulin pens, and long-term contact lenses. The CE pathway for Class IIb devices requires the involvement of designated institutions.

• Class III

High-risk devices, such as pacemakers, prosthetic heart valves, and breast implants, require rigorous clinical evaluation.

Preparation and Review of Technical Documents

Under the EU MDR, medical device manufacturers are required to prepare a series of technical documents to demonstrate the safety and efficacy of the product. To ensure that our clients' documents comply with regulatory requirements, we provide comprehensive technical documentation preparation and review services, including:

• Clinical Evaluation Report (CER)
• Post-marketing Surveillance (PMS) plan and report
• Periodic Security Update Report (PSUR)
• Post-marketing Clinical Follow-up (PMCF) plan and report
• Safety and Clinical Presentation Summary (SSCP)

Registration Process Management

The registration process for MDR products in the EU is complex, involving multiple links and the submission of numerous documents. Our team of regulatory experts has thoroughly studied the provisions of the EU MDR and is committed to managing and coordinating the entire registration process for you to ensure that your application goes smoothly.

• Product strategy planning
• Registration scheme development
• Communication and coordination
• Approval status tracking and feedback

Regulatory Interpretation and Training Support

We offer our clients the latest regulatory developments and standards interpretations, and customize regulatory training courses according to your needs to help your team improve regulatory awareness and compliance.

We understand the importance of your products entering the EU market, so we offer you the best service. Our goal is to be your reliable partner on the EU market, to help your medical device products quickly enter the EU market and win more business opportunities. If you need help or have any questions, please feel free to contact us.